Lokomat Versus Strength Training in Chronic Incomplete Spinal Cord Injury

Phase 1

Completed

Conditions: Spinal Cord Injury

Interventions: Device: RAGT
Other: Strength Training

Registration Number: NCT01087918

Lead Sponsor: University of Zurich

Brief Summary: 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: 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.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 9

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

Study & Design

Study Type: INTERVENTIONAL

Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
First RAGT, then strength training	RAGT	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.
First RAGT, then strength training	Strength Training	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.
First strength training, then RAGT	RAGT	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.
First strength training, then RAGT	Strength Training	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.

Primary Outcome Measures

Name	Time	Method
10 Meter Walking at Preferred Speed	Baseline, after intervention (4 weeks)	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.
10 Meter Walking at Maximal Speed	Baseline, after intervention (4 weeks)	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.

Secondary Outcome Measures

Name	Time	Method
Mean Latency of the Averaged Motor Evoked Potentials of the Right and the Left M. Tibialis	Baseline, after intervention (4 weeks)	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.
Walking Index for Spinal Cord Injury II	Baseline, after intervention (4 weeks)	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.
Berg Balance Scale	Baseline, after intervention (4 weeks)	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.
Spinal Cord Independence Measure III	Baseline, after intervention (4 weeks)	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.
Manual Muscle Test of the Lower Extremity	Baseline, after intervention (4 weeks)	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.
Pain on a Visual Analogue Scale	Baseline, after intervention (4 weeks)	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.
Response Time of the Lower Extremities	Baseline, after intervention (4 weeks)	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.
Falls Efficacy Scale	Baseline, after intervention (4 weeks)	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.
Figure of Eight Test	Baseline, after intervention (4 weeks)	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.