Lokomat Versus Strength Training in Chronic Incomplete Spinal Cord Injury

Study Overview
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Brief Summary
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The purpose of this pilot study is to investigate whether gait specific robotic supported bodyweight supported treadmill training and lower extremity strength training have similar beneficial effects on walking function and other outcomes.

Detailed Description
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Although task-specific training has been promoted during the last years to improve function, recent studies showed that after an incomplete spinal cord injury, strength, but not complex movement coordination, is affected. In this randomized cross-over trial we investigate the effectiveness of a task-specific 4 week Lokomat training with a 4 week (unspecific) lower extremity muscle strength training on walking-related and other outcomes.

Official Title
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Effects of Automated Treadmill Training and Lower Extremity Strength Training on Walking-related and Other Outcomes in Subjects With Chronic Incomplete Spinal Cord Injury

Conditions
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Spinal Cord Injury

Intervention / Treatment
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* Device: RAGT
* Other: Strength Training


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Time since lesion > 1 year Outdoor mobility SCIM III < 5 Stable walking capacity Exclusion Criteria: participating on other training studies osteoporosis psychiatric diseases epilepsia body weight > 130 kg cardiac pacemaker

Ages Eligible for Study
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Minimum Age: 16 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: First RAGT, then strength training<br>16 sessions of 45 minutes of robot-assisted gait training 4 times a week in first intervention period and 16 sessions of 45 minutes of strength training 4 times a week in second intervention period. | Device: RAGT<br>* 16 sessions / 4 times/week / 45 minutes Lokomat training<br>Other: Strength Training<br>* 16 sessions / 4 times/week / 45 minutes lower extremity strength training<br>|
| Experimental: First strength training, then RAGT<br>16 sessions of 45 minutes of strength training 4 times a week in first intervention period and 16 sessions of 45 minutes of robot-assisted gait training 4 times a week in second intervention period. | Device: RAGT<br>* 16 sessions / 4 times/week / 45 minutes Lokomat training<br>Other: Strength Training<br>* 16 sessions / 4 times/week / 45 minutes lower extremity strength training<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 10 Meter Walking at Preferred Speed | The 10 meter walk test assesses the time required to walk 10 meters at the patient's preferred speed (in seconds). Results were converted to walking speed [m/s]. Displayed are values after each intervention (RAGT or strength training) minus value at baseline. Positive values denote improvements. | Baseline, after intervention (4 weeks) | 
| 10 Meter Walking at Maximal Speed | The 10 meter walking speed assesses the time needed to walk 10 meters at maximal speed (in seconds). Results were converted to walking speed [m/s]. Displayed are values after each intervention (RAGT or strength training) minus value at baseline. Positive values denote improvements. | Baseline, after intervention (4 weeks) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Walking Index for Spinal Cord Injury II | The WISCI II describes whether a patients requires waling aids, braces or personal assistance to walk 10 meters. It is an ordinal scale varying from 0 (= not able to walk 10 meters) to 20 (= able to walk 10 meters with no walking aids, braces or personal assistance). Displayed are values after each intervention (RAGT or strength training) minus value at baseline. Positive values denote improvements. | Baseline, after intervention (4 weeks) | 
| Berg Balance Scale | The Berg Balance Scale is a performance-based measure of balance. It is scored from 0 (= failed all items) to 56 points (= scored maximally in all items). Displayed are values after each intervention (RAGT or strength training) minus value at baseline. Positive values denote improvements. | Baseline, after intervention (4 weeks) | 
| Spinal Cord Independence Measure III | The SCIM assesses functional independence after spinal cord injury. It is scored from 0 (= total dependence in everyday life) to 100 points (= complete independence in everyday life). Displayed are values after each intervention (RAGT or strength training) minus value at baseline. Positive values denote improvements. | Baseline, after intervention (4 weeks) | 
| Mean Latency of the Averaged Motor Evoked Potentials of the Right and the Left M. Tibialis | Motor evoked potential was elicited by transcranial magnetic stimulation. Displayed are values after each intervention (RAGT or strength training) minus value at baseline. Negative values denote improvements. | Baseline, after intervention (4 weeks) | 
| Manual Muscle Test of the Lower Extremity | With the manual muscle test, we examined strength of the lower extremities. Five key muscles on each side are evaluated from 0 (= total paralysis) to 5 (= normal strength). Values for left and right were then averaged. Displayed are values after each intervention (RAGT or strength training) minus value at baseline. Positive values denote improvements. | Baseline, after intervention (4 weeks) | 
| Pain on a Visual Analogue Scale | Pain was scored on a visual analogue scale from 0 (= no pain) to 100 (= maximal pain). Displayed are values after each intervention (RAGT or strength training) minus value at baseline. Negative values denote improvements. | Baseline, after intervention (4 weeks) | 
| Response Time of the Lower Extremities | We measured choice stepping response time on a plate in a standing position. Participant had to move their feet to flashing LEDs as fast as possible. Valid values of the right and the left foot were averaged. Displayed are values after each intervention (RAGT or strength training) minus value at baseline. Negative values denote improvements. | Baseline, after intervention (4 weeks) | 
| Falls Efficacy Scale | The Falls Efficacy Scale evaluates fear of falling in everyday life situations. It is scored from 16 (= no fear at all) to 64 points (= maximal fear in all items). Displayed are values after each intervention (RAGT or strength training) minus value at baseline. Negative values denote improvements. | Baseline, after intervention (4 weeks) | 
| Figure of Eight Test | The Figure of Eight Test is a 10m Walk Test in the shape of a figure of eight. Time for completion of one lap is recorded and converted to [m/s]. Displayed are values after each intervention (RAGT or strength training) minus value at baseline. Positive values denote improvements. | Baseline, after intervention (4 weeks) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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ASIA C and D