Locomotor Training in Persons With Multiple Sclerosis

• Sponsor: University of California, Los Angeles (Other)
• Overall Status: Completed
• CT.gov ID: NCT00607126
• Collaborator: National Multiple Sclerosis Society (Other)
• Enrollment: 38
• Location: 1
• Arms: 2
• Duration (Months): 37
• Patients Per Site Per Month: 1

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Multiple Sclerosis	Device: Lokomat; Procedure: resistive training	Phase 1/Phase 2

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.

Study Design

• Study Type: Interventional
• Actual Enrollment: 38 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: Robotic Locomotor Training in Persons With Multiple Sclerosis
• Study Start Date: Jul 1, 2006
• Actual Primary Completion Date: Aug 1, 2009
• Actual Study Completion Date: Aug 1, 2009

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 1 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 patient is suspended over a treadmill while their legs are in the Lokomat, which moves the legs on the treadmill.	Device: Lokomat; locomotor training using body weight support on a treadmill
Active Comparator: 2 resistive training using weights and therabands	Procedure: resistive training; resistive training using theraband and/or weights

Outcome Measures

Primary Outcome Measures

1. 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 Outcome Measures

1. Distance [baseline, mid point, end and 12 weeks after training]

   distance assessed by 6 minute walk test

2. 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.

3. 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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 65 Years
• Sexes Eligible for Study: All
• Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	UCLA	Los Angeles	California	United States	90095

Sponsors and Collaborators

• University of California, Los Angeles
• National Multiple Sclerosis Society

Investigators

• Principal Investigator: Barbara S Giesser, MD, University of California, Los Angeles

Study Documents (Full-Text)

None provided.

More Information

Publications

• Giesser B, Beres-Jones J, Budovitch A, Herlihy E, Harkema S. Locomotor training using body weight support on a treadmill improves mobility in persons with multiple sclerosis: a pilot study. Mult Scler. 2007 Mar;13(2):224-31.
• Giesser B, Herlihy E, Plummer D'Amato P et al. Randomized controlled trial of robotic locomotor training in persons with MS. Multiple Sclerosis Journal 17S481 ( 2011)

• Responsible Party: Barbara Giesser, Clinical Professor of Neurology, University of California, Los Angeles
• ClinicalTrials.gov Identifier: NCT00607126
• Other Study ID Numbers: 06-04-064-02; RG3724-A-4
• First Posted: Feb 5, 2008
• Last Update Posted: Aug 15, 2016
• Last Verified: Jul 1, 2016

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Keywords provided by Barbara Giesser, Clinical Professor of Neurology, University of California, Los Angeles: impaired ambulation
• Additional relevant MeSH terms: Multiple Sclerosis; Sclerosis

Study Results

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 Detail	38 subjects were consented and randomized; two subjects volitionally dropped out before participating in the study; this accounts for the discrepancy..

Arm/Group Title	Lokomat Training Using Body Weight Support on a Treadmill	Resistive Training
Arm/Group Description	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.	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.
Period Title: Overall Study
STARTED	17	19
COMPLETED	17	19
NOT COMPLETED	0	0

Baseline Characteristics

Arm/Group Title	Lokomat Training Using Body Weight Support on a Treadmill	Resistive Training	Total
Arm/Group Description	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.	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.	Total of all reporting groups
Overall Participants	17	19	36
Age (Count of Participants)
<=18 years	0 0%	0 0%	0 0%
Between 18 and 65 years	17 100%	19 100%	36 100%
>=65 years	0 0%	0 0%	0 0%
Sex: Female, Male (Count of Participants)
Female	9 52.9%	14 73.7%	23 63.9%
Male	8 47.1%	5 26.3%	13 36.1%
Region of Enrollment (participants) [Number]
United States	17 100%	19 100%	36 100%
EDSS (units on a scale) [Mean (Full Range) ]
Mean (Full Range) [units on a scale]	6.5	6.0	6.3

Outcome Measures

1. Primary Outcome

Title	Walking Speed as Assessed by 25' Timed Walk
Description	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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Lokomat Training Using Body Weight Support on a Treadmill	Resistive Training
Arm/Group Description	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.	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.
Measure Participants	17	19
25"TW baseline	22.7 (17.6)	10.6 (4.9)
25'TW midpoint	23.9 (20.9)	9.8 (4.3)
25'TW end point	19.4 (15.2)	9.6 (3.7)
25'TW post	21.7 (16.7)	10.5 (4.3)

2. Secondary Outcome

Title	Distance
Description	distance assessed by 6 minute walk test
Time Frame	baseline, mid point, end and 12 weeks after training

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Lokomat Training Using Body Weight Support on a Treadmill	Resistive Training
Arm/Group Description	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.	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.
Measure Participants	17	19
6 min walk baseline	367 (241)	753 (232.3)
6 min walk midpoint	474 (354)	813 (253.8)
6 minute walk end point	436 (288)	769 (261.9)
6 minute walk post	457 (300.5)	742 (248.2)

3. Secondary Outcome

Title	Fatigue
Description	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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Lokomat Training Using Body Weight Support on a Treadmill	Resistive Training
Arm/Group Description	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.	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.
Measure Participants	17	19
MFIS baseline	34.1 (14.1)	37.7 (15.6)
MFIS mid point	26.7 (13.7)	29.4 (15.0)
MFIS end point	26.8 (16.6)	29.9 (17.7)
MFIS post	27.4 (19.8)	35.3 (15.9)

4. Secondary Outcome

Title	PASAT
Description	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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Lokomat Training Using Body Weight Support on a Treadmill	Resistive Training
Arm/Group Description	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.	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.
Measure Participants	17	19
PASAT baseline	48.2 (5.1)	46.8 (3.8)
PASAT Mid point	0.06 (1.17)	0.42 (1.03)
PASAT end point	1.3 (1.13)	0.58 (1.03)
PASAT post	1.90 (1.13)	-0.91 (1.13)

Adverse Events

Arm/Group Title	Lokomat Training Using Body Weight Support on a Treadmill		Resistive Training
Arm/Group Description	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.		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.
All Cause Mortality
	Lokomat Training Using Body Weight Support on a Treadmill		Resistive Training
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)
Serious Adverse Events
	Lokomat Training Using Body Weight Support on a Treadmill		Resistive Training
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/17 (0%)		0/19 (0%)
Other (Not Including Serious) Adverse Events
	Lokomat Training Using Body Weight Support on a Treadmill		Resistive Training
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/17 (0%)		0/19 (0%)

Limitations/Caveats

This was a small study and the number of subjects enrolled may not have been sufficient to show an effect.

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.