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Clinical Trials/NCT01087918
NCT01087918
Completed
Phase 1

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

University of Zurich1 site in 1 country9 target enrollmentJuly 2009

Overview

Phase
Phase 1
Intervention
Not specified
Conditions
Spinal Cord Injury
Sponsor
University of Zurich
Enrollment
9
Locations
1
Primary Endpoint
10 Meter Walking at Preferred Speed
Status
Completed
Last Updated
13 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
July 2009
End Date
September 2011
Last Updated
13 years ago
Study Type
Interventional
Study Design
Crossover
Sex
All

Investigators

Responsible Party
Sponsor

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

Outcomes

Primary Outcomes

10 Meter Walking at Preferred Speed

Time Frame: 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

Time Frame: 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 Outcomes

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

Study Sites (1)

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