Zanaflex

ABSTRACT

Background and Purpose: Impaired walking ability, balance, and fatigue are common problems for people with multiple sclerosis (MS).The purpose of this case report is to describe the use of plan of care that included locomotor training using both a body weight support (BWS) with a treadmill (TM) and overground walking as well as a virtual reality (VR)-based balance intervention to improve walking ability, balance, and endurance for an individual with MS. case Description: The client was a 48-year-old female with a 10-year history of MS. Her main goals were to improve walking ability, balance, and endurance. She presented with impaired gait, balance, motor function, and increased fatigue. Locomotor training using a BWS/TM system and overground and VR-based balance interventions were implemented 2 days a week for 12 weeks. Outcomes: The client demonstrated improvements in gait speed, gait endurance, and balance postintervention and maintained the improvements at a 2-month follow up. Discussion:This case report is the first to report on the use of locomotor training with BWS/TM system and overground and VRbased balance interventions for a client with MS. The plan of care was formulated based on the patient's goals and the available literature on the use of the interventions with other patients with neurologic conditions to provide an intervention that was task-oriented, skilled, and intensive.

Key Words: multiple sclerosis, locomotor training, body weight support, virtual reality, gait, balance

INTRODUCTION

There are approximately 400,000 individuals in the United States living with Multiple Sclerosis (MS).1 Multiple Sclerosis is a chronic, progressive neurological disease with a clinical course that may result in severe disability. Common symptoms for individuals with MS include paresis, sensory impairment, spasticity, balance deficits, and fatigue.2 These impairments often lead to gait disturbances and difficulty walking. Approximately 50% of individuals with MS will require assistance and/or an assistive device to ambulate short distances within 15 years of onset of the disease.1 Between 50% and 60% of people with MS identify fatigue as the worst symptom that they experience.4,5 Increased fatigue may affect the functional walking endurance of individuals with MS. It is therefore important to develop effective rehabilitation interventions to address gait, balance, and endurance in individuals with MS.

Different authors have compared the effectiveness of task-oriented physical therapy interventions to a facilitation-based approach to improve walking ability and balance in individuals with MS.6,7 Both methods have been shown to improve functional mobility, walking speed, and balance.6,7 However, neither approach was shown to be more beneficial than the other.6,7

Aerobic training utilizing an ergometer also has been evaluated with individuals with MS.8,9 One group of researchers found that 3 to 4 weeks of lower extremity (LE) training in combination with in-patient rehabilitation produced significant improvements in aerobic threshold, health perception, and activity level compared to in-patient rehabilitation alone." Rodgers and colleagues1' found that a 6-month aerobic training program consisting of a combined upper extremity GJE) and LE ergometer had minimal effects on gait characteristics. After the training period, the subjects demonstrated a decrease in gait velocity, ankle dorsiflexion, and maximum hip extension.9

Locomotor training using a body weight support (BWS) and treadmill (TM) system is a task-oriented intervention that has shown promise in improving walking ability in individuals who have experienced neurological injuries such as a spinal cord injury,10-13 Parkinson disease," and stroke.15-18 Locomotor training with a BWS/TM involves suspending the client in a parachute-like harness over a treadmill, which allows for a percentage of the client's weight to be relieved. Therapists are able to provide manual assistance to facilitate a normal walking pattern. This training modality allows for repetitive locomotor training throughout a complete gait cycle.

The use of virtual reality (VR)-based rehabilitation interventions has more recently been advocated as a potentially effective technique to improve function, gait, and balance in individuals with traumatic brain injury19,20 and stroke.21-24 Although both of these interventions-locomotor training with a BWS/TM system and VR based interventions-have shown promise with individuals with various neurological disorders, the literature has not reported on their use with individuals with MS. The purpose of this case report is to describe an intervention program consisting of locomotor training utilizing a BWS/TM system and overground and VRbased balance training with the goal of improving walking ability, balance, and endurance in a client with MS.

CASE DESCRIPTION

Examination

History

The client was a 48-year-old female with a diagnosis of MS. She had been diagnosed with MS 10 years earlier. The orders from the prescribing physician stated that the patient was being referred for physical therapy due to MS with lower extremity spasticity to improve ambulation. She reported that she was not going out as much with her family because she could not keep up with them and would become fatigued. However, she had not experienced an acute exacerbation of her symptoms at this time. She also stated that she was falling occasionally when doing yard work or walking on uneven surfaces. Her Expanded Disability Status Scale (EDSS)25,26 score was a 2.5. The EDSS is a 10-point scale, with scores ranging from O to 10, for rating overall disability in individuals with MS. The EDSS focuses on walking ability as the primary indicator of disability,- She was taking the following medications: Avonex, Baclofen, and Zanaflex. The appropriate institutional review board approved this case study and the client provided informed consent.

Physical therapy tests and measures

The client was able to ambulate independently without an assistive device. Her self-selected gait speed, as measured over the middle 10 m of a 14 m walk, was 0.95 m/s and her gait endurance as measured over a 6-minute walk at her self-selected speed was 329 meters. Gait speed is a valid and reliable measure of walking ability in individuals with MS.27-29 Although the 6-minute walk test has not been validated with individuals with MS, it is used with a variety of patient populations as a measure of walking endurance including those with cardiac disease,30,31 pulmonary disease,32 older adults,33,34 stroke,35-37 and brain injury.35 Since a primary complaint of the patient was her inability to keep up with her family when walking in the community it was decided that the 6-minute walk test would be a clinically useful method of measuring her walking endurance.

Balance was assessed using a variety of different tests and measures. She demonstrated a positive Romberg with feet together with eyes closed. She could stand in this position for 6 seconds. Her Berg Balance Scale38 (BBS) score was a 49/56. Although primarily used with geriatric clients and individuals with stroke, the BBS is a valid measure of balance for individuals with MS.39-41

The client's self-efficacy in her balance was assessed using the Activities-specific Balance Confidence (ABC) scale.42 The ABC scale is a 16-item questionnaire that is administered through an interview. Total scores range from 0% (no confidence) to 100% (completely confident) in maintaining balance while performing 16 functional tasks. The ABC scale was originally designed to measure balance self-efficacy in community dwelling elders and has been shown to be valid and reliable with this population.42 Although this outcome measure has not been used with people with MS, no comparable tool was found that had been validated with this population. The client's perception and confidence in her balance were one of the primary reasons the client sought out physical therapy services so it was decided that the ABC scale would be a clinically useful tool to measure this aspect of her balance. The client's initial score on the ABC scale was 73%.

Further balance testing was done using the sensory organization test (SOT) on the NeuroCom SMART Balance Master® (NeuroCom International, Inc., Clackamas, Ore). The platform posturography SOT of the Balance Master® has been shown to provide useful diagnostic information in patients with MS.43 The SOT identifies impairments in the 3 primary sensory systems that contribute to balance: vestibular, vision, and somatosensory. The composite equilibrium score quantifies the center of gravity sway under the 6 different sensory conditions of the SOT:(1) normal vision with fixed support surface, (2) absent vision with fixed support surface, (3) sway referenced vision with fixed support surface, (4) normal vision with sway support surface, (5) absent vision with sway support surface, and (6) sway referenced vision and support surface. The client's initial composite equilibrium score was 65 and her sensory analysis vestibular score was 38. Both of these scores were less than the score achieved by 95% of age-matched individuals with no history or symptoms of balance dysfunction reported by the manufacturer (Table 1).

Fatigue was assessed using the abbreviated Modified Fatigue Impact Scale (MFIS) 5-item version." The MFIS 5item version contains 5 statements that describe how fatigue may impact an individual with MS. For example, one of the statements is "I have had trouble maintaining physical effort for long periods of time." The client was asked to rate how her fatigue has affected her during the past 4 weeks for each of the 5 statements on a 5-point ordinal scale with O equal to 'never' and 4 equal to 'almost always.' Scores range from 0 to 20, with a lower score indicating less fatigue. The MFIS was designed and validated specifically for individuals with MS.5 The client's initial MFIS 5-item score was a 5/20.

The client's motor function in her UEs was within normal limits. The client exhibited impaired motor function in both of her LEs, with the left being more severely affected. The tone in her left knee extensors and plantar flexors was a 3 on the modified Ashworth scale's and it was a 2 in these same muscle groups in her right lower extremity. Muscle performance was measured using manual muscle testing procedures as described by Daniels and Worthingham.46 These ranged from 5/5 to 3+/5 in the right lower extremity and 4/5 to 3-/5 in the left lower extremity. The client's sensation was tested as described by Schmitz47 and was intact to light touch, pain, and proprioception in both lower extremities except for being impaired to light touch at the L5 dermatome in the left lower extremity. Passive range of motion (PROM) was grossly within functional limits in both lower extremities except for left hip extension was 5° from neutral.

The author, who had 9 years of experience working with clients with neurological disorders, performed all of the tests and measures during the client's first visit in the order presented above with the exception of the ABC] scale, MFIS5 item version, and the Balance Master* testing. The 2 questionnaires were administered at the end of the examination process on the first day and the Balance Master" testing was done during the client's second physical therapy session. Table 1 summarizes the relevant findings from the initial physical therapy examination.

Evaluation/Diagnosis/Prognosis

The data from the initial examination revealed impairments in endurance, motor function, strength, and PROM. Functional limitations were noted in the client's walking ability and balance. These findings agreed with the client's main concerns and reasons for seeking physical therapy services. Using the Guide to Physical Therapist Practice,*" the client was classified in the neuromuscular practice pattern EImpaired Motor Function and Sensory Integrity Associated With Progressive Disorders of the Central Nervous System.

Due to the chronic, progressive nature of MS the author and client discussed that although she may demonstrate improvement in walking ability, balance, and endurance over the course of her physical therapy she would likely still exhibit deficits in these areas after her treatment was completed. The client was very knowledgeable regarding the course of the disease and understood this. The primary goals established in conjunction with the client were to improve her gait speed, walking endurance, and balance.

The Guide to Physical Therapist Practice'" presents a range of 6 to 50 visits in this practice pattern. Based on the client's availability, review of the existing literature," "'* and insurance constraints the number of treatment sessions was set at 24. The client came to therapy 2 times per week for 12 weeks.

The plan of care was developed in collaboration with the client to address the impairments and functional limitations identified by the initial examination. Three main types of interventions were provided to address these areas: locomotor training using a BWS/TM system and overground, a VRbased balance system, and a home exercise program (HEP).

Locomotor training using a BWS/TM modality and overground is a task-oriented intervention that is based on neurophysiologieal prineiples of walking.49-51 There has been extensive and ongoing research primarily with individuals with SCI,10-13 stroke,15,16,18 and Parkinson disease" regarding its effectiveness. Although its use with individuals with MS has not been reported previously, the author thought that this intervention as part of the comprehensive plan of care might be beneficial for improving the client's walking ability because of its sound theoretical basis and effectiveness with individuals with other neurological disorders. Previous research with regards to other techniques to improve walking ability in individuals with MS has not shown one treatment approach to be more effective than another.

A VR-based balance intervention was chosen because the virtual environment provided a setting that encouraged and rewarded movement and was a method for practicing balance skills in a novel way. This intervention also made it necessary for the client to perform a cognitive task, ie, participate and interact with the game in the virtual world, while maintaining her balance.

A HEP was designed to supplement the interventions done in the clinic to ultimately improve the client's walking ability, balance, and endurance. The HEP consisted of riding a stationary combined UE and LE ergometer, LE and trunk strengthening exercises, and standing balance exercises.

Intervention

The interventions were provided by the author and when more than one person was necessary to provide the interventions physical therapist students who were in the second year of a 2 1/2-year program assisted. Each therapy session was approximately one hour long.

Locomotor Training

Locomotor training consisted of training in 2 environments: the BWS-TM environment, which was followed by overground walking. Initially a goal of a total of 15 minutes of walking in the BWS-TM environment and 10 minutes of overground walking was set. Locomotor training, in both environments, followed the principles developed by Behrman and Harkema11,52: (1) maximize weight bearing through the lower extremities and minimize or eliminate weight bearing through the arms; (2) provide sensory input consistent with normal walking; (3) promote trunk, limb, and pelvic kinematics associated with normal walking; (4) promote balance and upright control associated with normal walking; and (5) maximize the recovery and use of normal movement patterns and minimize the use of compensatory movement strategies. Another critical component was also included, educating the client to incorporate the strategies learned during the locomotor training into her everyday life.

Locomotor training in the BWS-TM environment consisted of having the client suspended in a harness over aTM using a Biodex Unweighting system (Biodex Medical Systems, Inc., Shirley, NY). In order to promote the principles described above to facilitate improvement in walking ability the following variables were manipulated in the BWS-TM environment: (1) amount of BWS, (2) TM training speed, (3) duration of walks during each session, (4) manual assistance and verbal cues. Initially, 20% BWS was provided while training on the TM, with a goal of 0% BWS by the end of the 12 weeks. The goal with treadmill speed was to train as close as possible to normal walking speeds for this client's age, 1.02 m/s to 1.37 m/s." Three 5-minute walks were set as a goal for each session.

Initially, 3 trainers provided manual assistance while training in the BWS-TM environment. The team of trainers worked with the client during step training to promote a stepping pattern that closely resembled normal gait kinematics and sensory feedback associated with normal walking. The trunk/pelvic trainer provided manual assistance and verbal cues to maintain an upright trunk and head centered over the pelvis. This trainer also provided manual assistance at the pelvis to facilitate pelvic rotation and weight shifting during walking. The LE trainers provided manual assistance at the knees and ankles to facilitate stepping. The goal was to walk with improved gait kinematics without manual assistance.

Locomotor training overground consisted of gait training with the client on level surfaces in the clinic. The client held on to 2 crutches that were held parallel to the ground by 2 trainers, while one trainer stood behind the client to provide manual facilitation at the pelvis. The client would then walk overground while the 2 trainers swung the crutches back and forth to promote symmetrical arm swing. The third trainer, directly behind the client, provided manual cues to facilitate weight shifting and pelvic and lower trunk kinematics associated with a normal walking pattern. During each overground locomotor training session the client ambulated for 25 meters 4 to 6 times at her -selected speed for a total distance between 100 and 150 meters.

During training in both environments, educating the client through verbal cues while training and discussion during rest periods was incorporated. The 5 training principles listed above were described to the client. A particular emphasis was placed on maintaining an upright head and trunk posture while walking, improving left LE kinematics during swing, and minimizing compensatory movement. As the training progressed less feedback was provided and the client was asked to provide an analysis of how the session went. The therapist and client also discussed how to incorporate what she was learning into her walking during everyday life.

Balance Training

Balance intervention consisted of training in a virtual environment using the Interactive Rehabilitation and Exercise Systems (IREX) developed byJesterTek (JesterTek, Inc., Port Jefferson, NY). With the IREX system the client stood facing a television screen and camera. The camera captured the client's image and projected it onto the television screen in front of her. The client then saw her image in the virtual environment on the screen in front of her. The system calculates the position of the client to determine if they have contacted an object in the virtual environment or uses the position of the client's extremities and trunk to control movement in the virtual environment. IREX contains various virtual scenes with objects to block and courses to navigate. The speed and location at which the virtual objects appear in the different virtual scenarios can be modified to make the intervention more difficult or easier. For example, one balance intervention used was called 'Formula Racing.' In this virtual environment the client saw herself in a racecar on a track (Figure 1). By shifting her weight from side to side she could 'steer' the car around the track while trying to avoid and pass other cars on the track. The speed at which other cars appear on the virtual racetrack can be changed. Another virtual training game incorporated into her treatment was 'Sharkbait.' In this virtual environment the client saw herself submerged in a deep-sea environment. By shifting her weight to the left and right and squatting up and down, the client moved within the virtual scene. The goal of the game was to capture stars by moving into them while avoiding other objects such as sharks and eels. This game facilitated weight shifting side to side within her base of support while flexing and extending her knees and hips at the same time.

Other virtual scenarios in the IREX system that were used as balance intervention were 'Snowboard' and 'Soccer.' These scenarios were chosen to promote weight shifting on to the client's left LE. While performing all of the VR balance interventions the client stood on a 5-inch piece of dense foam and a trainer stood behind the client to facilitate weight shifting to the left and for safety.The use of foam was selected to challenge the vestibular component of balance training. Each balance training session lasted approximately 20 minutes.

Home Exercise Program

The HEP was designed to address 5 areas: (1) endurance, (2) PROM, (3) balance, (4) LE and trunk strength, and (5) walking ability. On days that the client did not have therapy she began riding a stationary ergometer that combined both arm and leg pedaling. Initially she was able to pedal the bike for 3 minutes without stopping. She increased the time on the bike as tolerated throughout the intervention period. Due to her tight hip flexors and calf muscles, the client was instructed in a stretching program to perform twice a day. This entailed stretching these muscle groups while holding the stretch for at least 30 to 60 seconds 5 to 10 times. The balance exercises consisted of standing in a tandem position with eyes closed and attempting unilateral stance with eyes open on both LEs while maintaining her balance for 5 to 10 seconds or for as long as she was able. The client was instructed to stand near a countertop when performing these exercises. Pelvic and trunk stabilization and LE strengthening exercises were prescribed and done once a day. These consisted of wall squats, abdominal crunches, and various bridging exercises. These exercises were reviewed with the client in therapy, and she then performed them independently at home. The client was able to demonstrate the ability to do the exercises correctly at a later date in a therapy session.

Outcomes

Over the course of the 12-week intervention period, the client participated in a total of 20 out of a possible 24 sessions. The client had to cancel 4 sessions due to work-related issues. During the 20 sessions she completed 19 locomotor training sessions and 13 VR balance-training sessions. Locomotor and VR balance interventions were not completed every training session due to time constraints. The client reported that she performed the HEP on a daily basis during the 12-week intervention period. The client also returned 2 months after completing the 12-week intervention period for a follow up appointment. The client reported that she continued riding her stationary ergometer daily during this time. She performed the stretching, strengthening, and balance exercises as well, but not consistently.

During the first training session, the client was able to ambulate for a total of 10 minutes in the BWS-TM environment. By the fourth session, she was able to ambulate for the stated goal of a total of 15 minutes for each training session and stayed there for the rest of the intervention period. The amount of BWS and number of trainers was reduced over time. Initially she required 20% BWS, by the 12th session she was able to train with 0% BWS. For the first 8 training sessions, 3 trainers were required to assist the client. From session 9 through 16, 2 trainers were necessary, one at her trunk/pelvis and one at her left LE. For the last 3 training sessions only one trainer was required at her left LE. The progression of TM training speed and duration of individual walks during each session are provided in Figure 2a and 2b respectively.

Walking ability, balance, and fatigue outcomes are presented in Table 1. The client's gait speed over 10 m and 6-minute walk distance improved over the course of the 12 weeks by 21% and 24.6% respectively. Her scores on the BBS,ABC scale, and MFIS-5 item version also improved. The client was able to maintain these improvements 2 months after the treatment ended.

The client's performance on the Balance Master" SOT improved from pre- to postintervention (seeTable 1). These measures also stayed consistent at the 2-month follow-up except for a decrease in the composite equilibrium score and the visual preference ratio (see Table 1).

In an interview with the client at the end of the 12-week intervention period, she described improvements in her balance, walking ability, and endurance. She stated that she felt more comfortable and safer ambulating for longer distances in crowded areas. She no longer limited her social activities. For example, during the second to last week of the intervention period she went to a day-long function at her daughter's high school, which involved walking throughout the day in a crowded school. She reported that she felt safe and had no periods of fatigue or difficulties walking throughout the day, where as prior to completing the 12-week intervention period she stated she might not have gone to the function.

DISCUSSION

To date no literature has reported on the use of locomotor training -with a BWS/TM system and overground or VR-based balance interventions for individuals with MS to address walking and balance deficits. This client's walking ability as measured by a 10 m walk and 6-minute walk improved after 20 intervention sessions of a comprehensive physical therapy plan of care that incorporated both of these interventions as well as a targeted HEP. At the completion of the treatment program, the client's gait speed and gait endurance improved by 21% and 24.6%, respectively; and these gains were maintained 2 months later. Prior to starting the interventions, the client's gait speed was less than reported values for age-matched healthy women. At the end of the 12-week treatment period, the client's gait speed fell within reported normative values.vvil Although the change in her 6-minute walk distance was greater than reported minimal detectable change values," it still remained slightly less than would be expec-ted of a healthy woman the same age, height, and weight based on prediclive equations developed by Enright and Sherrill.56

The magnitude of change in gait velocity demonstrated by this client falls within the range of that in other studies. In a study by Lord and colleagues,6 patients with MS who received a facilitation-based approach to treatment improved their gait speed by 40%. Patients who received a task-oriented approach to treatment improved their gait speed by 35.5%.6 In a crossover design study, Wiles et al" reported an 8.6% and 5% increase in walking speed when patients received home-based physical and outpatient physical therapy respectively. It is difficult to directly compare these changes with the client in this case report as the client was higher functioning than the patients reported in these studies. The initial mean gait speed of patients in the study by Lord et al6 was 0.30 m/s for the group that received a facilitation-based approach and 0.41 m/s for the group that received task-oriented physical therapy, compared to 0.95 m/s for this client. In the study by Wiles et al" the mean EDSS score of the patients was 4.0, compared to 2.5 for this client.

The client's BBS also improved, but it is difficult to say whether this was a clinically significant change since it only improved by 4 points. Additionally, the client demonstrated relatively high scores on this test on all 3 occasions that it was taken. The BBS may not have been the most appropriate test to measure change in balance with this client.

Following the intervention period, the client's scores on the SOT of the Balance Master fell within age referenced norms reported by the manufacturer. This improvement was maintained at 2-month follow up except for a decrease in composite equilibrium and visual preference scores to below the reported age referenced norms. It is difficult to assess what may have caused these declines. The client may have experienced a temporary exacerbation of MS-related symptoms on the day of testing.

The client reported subjective improvements in her balance and level of fatigue as demonstrated by the change in the ABC scale and MFIS 5 item version. It is difficult to assess whether these are true changes as there are no reports in the literature as to what is considered a minimal detectable change with either of these outcome measures. The client made other subjective comments that may be indicative of improvements in walking ability, balance, and endurance. She reported that she went out in social situations more often and was better able to keep up with family members and friends when in the community. For example, she did not have to take repeated rests when going to the mall or to a baseball game.

It is not possible to determine the individual impact that each of the different interventions had on the changes in walking, balance, and endurance the client demonstrated. Locomotor training with the BWS/TM system and overground not only may have improved her walking ability it may have had an influence on her balance as well. Research with other populations has shown that this type of intervention has improved balance, as measured by the BBS, as well as gait.11,15 Because of the importance of balance for walking the VR-based balance interventions may have had an impact on her walking ability. The HEP may have affected her gait, balance, and endurance. The comprehensive plan of care was designed to address all of the areas of functional limitation and impairments identified by the findings of the initial examination and areas of greatest concern to the client. This is in line with clinical practice where physical therapists often use many different interventions within a comprehensive treatment plan to address the varied limitations that clients often present with.

An interesting aspect of the VR-based balance training and locomotor training interventions used in this case report was the cognitive demands during training that were reported by the client. During both of these interventions, the client would often comment on how hard she had to think about how she was moving. For example, while performing locomotor training the client would state that she never thought about how she walked before. During therapy she had to concentrate on how she moved her legs and trunk much more than she had ever done previously. She stated that this aspect of the training was almost as challenging as the physical demands. Further research into the cognitive demands of these interventions and its affect on outcomes may be warranted.

This case report has many limitations. Controlled clinical studies need to be done to examine the effectiveness of each of these intervention strategies separately. Research also should examine the effect of these interventions on clients with MS with varying degrees of walking and balance impairment and chronicity of the disease. The impact of these treatments on other factors such as disability and ability to perform activities of daily living should also be examined. These interventions may not be feasible in some clinical settings due to the cost of the VR and BWS/TM Systems and the increased personnel that was initially necessary to deliver the locomotor training.

SUMMARY

The purpose of this case report was to describe the use of locomotor training with a BWS/TM system and overground, VR-based balance training, and a HEP to address limitations in walking, balance, and endurance in an individual with MS. These interventions were chosen because they are task-oriented, require skill, and can promote intensive training as demonstrated by previous research with other populations with neurological disorders.The plan of care was formulated based on the goals of the client. This client's outcomes suggest that a comprehensive treatment program incorporating locomotor training with a BWS/TM and overground and VR-based balance training along with a targeted HEP were feasible and appropriate interventions to improve walking ability, balance, and endurance for this individual with MS. Further research is necessary to determine if these interventions are generalizable and effective for other individuals with MS.

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George D. Fulk, PT, MSPT

Instructor, Physical Therapy Department, Clarkson University, Potsdam, NY (gfulk@clarkson.edu)

Copyright Neurology Report Mar 2005
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