Multiple Sclerosis
Conditions
Keywords
impaired ambulation
Brief summary
Locomotor training is a new exercise modality that emphasizes task specificity to promote learning and neural plasticity. It has been reported to improve walking in patients with stroke, spinal cord injury and cerebral palsy. In this study, 40 patients with impaired ambulation due to Multiple Sclerosis will be randomized to receive 36 sessions of either locomotor training or an standard resistive exercise intervention.The locomotor training will be accomplished via a robotic device, the Lokomat, which will move the patient's legs on a treadmill while they are suspended in a harness.
Detailed description
In this study, subjects with confirmed diagnosis of Multiple Sclerosis were randomized into one of two treatment arms. Subjects in the Lokomat arm trained on the Lokomat with a supervising physical therapist for 20-30 minutes/session 3 times/week. The Lokomat is a robotic exoskeleton which enables the subject to step on a moving treadmill. Subjects were suspended in a harness while in the Lokomat with full to partial body weight support as needed. After the training in the Lokomat, they practiced overground walking for 10 minutes. The other treatment arm had subjects engage in resistance training with weights and resistance elastic bands matched to the Lokomat group for intensity, duration and frequency. they did not practice overground walking. Primary outcome measure was speed to accomplish 25' timed walk.
Interventions
DEVICELokomat
locomotor training using body weight support on a treadmill
PROCEDUREresistive training
resistive training using theraband and/or weights
Sponsors
National Multiple Sclerosis Society
University of California, Los Angeles
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* Persons with Secondary progressive or Primary Progressive Multiple Sclerosis who are ambulatory with difficulty and /or assistive device
Exclusion criteria
* Ataxia * Unable to ambulate * Within 3 months of exacerbation
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Walking Speed as Assessed by 25' Timed Walk | at beginning,mid point, end and 12 weeks after intervention | This is the time needed for participant to walk 25 feet. Participant walks on a level surface. the walk from start to finish is timed with a stop watch three measures are done and the average value is entered. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Distance | baseline, mid point, end and 12 weeks after training | distance assessed by 6 minute walk test |
| Fatigue | baseline, mid, completetion, 3 months post | fatigue assessed by modified fatigue impact scale. This is a 21 item questionnaire which has a range from 0-84. Higher scores indicate more impact of fatigue on physical and cognitive functioning. |
| PASAT | baseline, mid, completion, 3 months post training | Cognitive measure of attention and information processing speed. Score goes from 0-60 with higher number indicating better performance. Scores are expressed as mean chamge rfom baseline; negative numbers indicate worse performance |
Countries
United States
Participant flow
Recruitment details
Prospective subjects were recruited from the MS clinic population of the UCLA Dep't/ of Neurology and from the general MS population in Los Angeles between 2007-2009. Recruitment flyers were approved by the UCLA Institutional Review board.
Pre-assignment details
38 subjects were consented and randomized; two subjects volitionally dropped out before participating in the study; this accounts for the discrepancy..
Participants by arm
| Arm | Count |
|---|---|
| Lokomat Training Using Body Weight Support on a Treadmill Locomotor training using body weight support on a treadmill, using robotic device to provide locomotor training. Locomotor training will be done using the Lokomat device. The Lokomat device is a robotic exoskeleton which fits over the patient's legs while they are suspended in a harness over a standard treadmill. the patient is suspended over a treadmill while their legs are in the Lokomat, which moves the legs on the treadmill. Patient had to be ambulatory with or without an assistive device. The amount of body weight support is gradually increased or decreased as needed.Partients were also given feedback by the physical therapist while they were walking on the treadmill. Patients trained for 30-40 minutes per session, for 3X/week. The average speed of training was 2.4km.hr. After lokomat training, the patients practiced over ground walking with the therapist for 15 minutes after each session. | 17 |
| Resistive Training resistive training using weights and therabands
This group trained for the same amount of time as the Lokomat group, i.e.3X/week for 30-40 minutes per session. they used resistive weights and /or theraband resistive bands to accomplish training. Exercises were done in supine, lying sitting and standing positions. Large muscle groups in both upper and lower extremities were trained. Patients completed 3 sets of 8-12 reps of each exercise, and performed 8-10 different exercises in each session. | 19 |
| Total | 36 |
Baseline characteristics
| Characteristic | Lokomat Training Using Body Weight Support on a Treadmill | Resistive Training | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 17 Participants | 19 Participants | 36 Participants |
| EDSS | 6.5 units on a scale | 6.0 units on a scale | 6.3 units on a scale |
| Region of Enrollment United States | 17 participants | 19 participants | 36 participants |
| Sex: Female, Male Female | 9 Participants | 14 Participants | 23 Participants |
| Sex: Female, Male Male | 8 Participants | 5 Participants | 13 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 17 | 0 / 19 |
| serious Total, serious adverse events | 0 / 17 | 0 / 19 |
Outcome results
Primary
Walking Speed as Assessed by 25' Timed Walk
This is the time needed for participant to walk 25 feet. Participant walks on a level surface. the walk from start to finish is timed with a stop watch three measures are done and the average value is entered.
Time frame: at beginning,mid point, end and 12 weeks after intervention
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Lokomat Training Using Body Weight Support on a Treadmill | Walking Speed as Assessed by 25' Timed Walk | 25'TW post | 21.7 seconds | Standard Deviation 16.7 |
| Lokomat Training Using Body Weight Support on a Treadmill | Walking Speed as Assessed by 25' Timed Walk | 25'TW end point | 19.4 seconds | Standard Deviation 15.2 |
| Lokomat Training Using Body Weight Support on a Treadmill | Walking Speed as Assessed by 25' Timed Walk | 25TW baseline | 22.7 seconds | Standard Deviation 17.6 |
| Lokomat Training Using Body Weight Support on a Treadmill | Walking Speed as Assessed by 25' Timed Walk | 25'TW midpoint | 23.9 seconds | Standard Deviation 20.9 |
| Resistive Training | Walking Speed as Assessed by 25' Timed Walk | 25'TW midpoint | 9.8 seconds | Standard Deviation 4.3 |
| Resistive Training | Walking Speed as Assessed by 25' Timed Walk | 25TW baseline | 10.6 seconds | Standard Deviation 4.9 |
| Resistive Training | Walking Speed as Assessed by 25' Timed Walk | 25'TW end point | 9.6 seconds | Standard Deviation 3.7 |
| Resistive Training | Walking Speed as Assessed by 25' Timed Walk | 25'TW post | 10.5 seconds | Standard Deviation 4.3 |
Secondary
Distance
distance assessed by 6 minute walk test
Time frame: baseline, mid point, end and 12 weeks after training
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Lokomat Training Using Body Weight Support on a Treadmill | Distance | 6 min walk baseline | 367 feet | Standard Deviation 241 |
| Lokomat Training Using Body Weight Support on a Treadmill | Distance | 6 min walk midpoint | 474 feet | Standard Deviation 354 |
| Lokomat Training Using Body Weight Support on a Treadmill | Distance | 6 minute walk end point | 436 feet | Standard Deviation 288 |
| Lokomat Training Using Body Weight Support on a Treadmill | Distance | 6 minute walk post | 457 feet | Standard Deviation 300.5 |
| Resistive Training | Distance | 6 minute walk post | 742 feet | Standard Deviation 248.2 |
| Resistive Training | Distance | 6 min walk baseline | 753 feet | Standard Deviation 232.3 |
| Resistive Training | Distance | 6 minute walk end point | 769 feet | Standard Deviation 261.9 |
| Resistive Training | Distance | 6 min walk midpoint | 813 feet | Standard Deviation 253.8 |
Secondary
Fatigue
fatigue assessed by modified fatigue impact scale. This is a 21 item questionnaire which has a range from 0-84. Higher scores indicate more impact of fatigue on physical and cognitive functioning.
Time frame: baseline, mid, completetion, 3 months post
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Lokomat Training Using Body Weight Support on a Treadmill | Fatigue | MFIS baseline | 34.1 units on a scale | Standard Deviation 14.1 |
| Lokomat Training Using Body Weight Support on a Treadmill | Fatigue | MFIS mid point | 26.7 units on a scale | Standard Deviation 13.7 |
| Lokomat Training Using Body Weight Support on a Treadmill | Fatigue | MFIS end point | 26.8 units on a scale | Standard Deviation 16.6 |
| Lokomat Training Using Body Weight Support on a Treadmill | Fatigue | MFIS post | 27.4 units on a scale | Standard Deviation 19.8 |
| Resistive Training | Fatigue | MFIS post | 35.3 units on a scale | Standard Deviation 15.9 |
| Resistive Training | Fatigue | MFIS baseline | 37.7 units on a scale | Standard Deviation 15.6 |
| Resistive Training | Fatigue | MFIS end point | 29.9 units on a scale | Standard Deviation 17.7 |
| Resistive Training | Fatigue | MFIS mid point | 29.4 units on a scale | Standard Deviation 15 |
Secondary
PASAT
Cognitive measure of attention and information processing speed. Score goes from 0-60 with higher number indicating better performance. Scores are expressed as mean chamge rfom baseline; negative numbers indicate worse performance
Time frame: baseline, mid, completion, 3 months post training
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Lokomat Training Using Body Weight Support on a Treadmill | PASAT | PASAT Mid point | 0.06 units on a scale | Standard Error 1.17 |
| Lokomat Training Using Body Weight Support on a Treadmill | PASAT | PASAT baseline | 48.2 units on a scale | Standard Error 5.1 |
| Lokomat Training Using Body Weight Support on a Treadmill | PASAT | PASAT post | 1.90 units on a scale | Standard Error 1.13 |
| Lokomat Training Using Body Weight Support on a Treadmill | PASAT | PASAT end point | 1.3 units on a scale | Standard Error 1.13 |
| Resistive Training | PASAT | PASAT post | -0.91 units on a scale | Standard Error 1.13 |
| Resistive Training | PASAT | PASAT baseline | 46.8 units on a scale | Standard Error 3.8 |
| Resistive Training | PASAT | PASAT end point | 0.58 units on a scale | Standard Error 1.03 |
| Resistive Training | PASAT | PASAT Mid point | 0.42 units on a scale | Standard Error 1.03 |