Clinical trial NCT01087918: Lokomat Versus Strength Training in Chronic Incomplete Spinal Cord Injury
Official title: Effects of Automated Treadmill Training and Lower Extremity Strength Training on Walking-related and Other Outcomes in Subjects With Chronic Incomplete Spinal Cord Injury
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Spinal Cord Injury
Keywords: ASIA C and D
Lead sponsor: University of Zurich
Sponsor class: OTHER
First posted: 2010-03-16
Enrollment: 9
Sex: ALL
Minimum age (years): 16
Maximum age (years): 70
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

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.

Eligibility criteria: 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

Primary outcomes:
measure: 10 Meter Walking at Preferred Speed
timeFrame: Baseline, after intervention (4 weeks)
measure: 10 Meter Walking at Maximal Speed
timeFrame: Baseline, after intervention (4 weeks)
Secondary outcomes:
measure: Walking Index for Spinal Cord Injury II
timeFrame: Baseline, after intervention (4 weeks)
measure: Berg Balance Scale
timeFrame: Baseline, after intervention (4 weeks)
measure: Spinal Cord Independence Measure III
timeFrame: Baseline, after intervention (4 weeks)
measure: Mean Latency of the Averaged Motor Evoked Potentials of the Right and the Left M. Tibialis
timeFrame: Baseline, after intervention (4 weeks)
measure: Manual Muscle Test of the Lower Extremity
timeFrame: Baseline, after intervention (4 weeks)
measure: Pain on a Visual Analogue Scale
timeFrame: Baseline, after intervention (4 weeks)
measure: Response Time of the Lower Extremities
timeFrame: Baseline, after intervention (4 weeks)
measure: Falls Efficacy Scale
timeFrame: Baseline, after intervention (4 weeks)
measure: Figure of Eight Test
timeFrame: Baseline, after intervention (4 weeks)
Other outcomes:
Locations:
city: Zurich
country: Switzerland
facility: Balgrist University Hospital
Study officials:
affiliation: University of Zurich
name: Huub van Hedel, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Labruyere R, van Hedel HJ. Strength training versus robot-assisted gait training after incomplete spinal cord injury: a randomized pilot study in patients depending on walking assistance. J Neuroeng Rehabil. 2014 Jan 9;11:4. doi: 10.1186/1743-0003-11-4.