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Clinical Trials/NCT02080039
NCT02080039
Terminated
Not Applicable

Clinical Pilot Study of the Effect of Electrical Stimulation of Denervated Muscles After Spinal Cord Injury

Swiss Paraplegic Research, Nottwil1 site in 1 country5 target enrollmentSeptember 2012
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ConditionsSpinal Cord Injury

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Spinal Cord Injury
Sponsor
Swiss Paraplegic Research, Nottwil
Enrollment
5
Locations
1
Primary Endpoint
Magnetic Resonance Imaging to determine the thickness of the gluteal muscle and fat tissue of the buttock.
Status
Terminated
Last Updated
11 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSitesSimilar Trials

Overview

Brief Summary

In this study the following hypotheses will be tested:

Electrical stimulation of the gluteal muscle (buttocks) leads to

  1. an increase in the thickness of the gluteal muscle
  2. a decrease in the thickness of the fat of the buttock area
  3. a change in the distribution of the middle and maximal seating pressure to a more consistent pressure
  4. an increase in well-being of the patients.
Registry
clinicaltrials.gov
Start Date
September 2012
End Date
November 2014
Last Updated
11 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Sponsor
Swiss Paraplegic Research, Nottwil
Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • •Duration of palsy: minimum two years after traumatic or non-traumatic spinal cord injury
  • •Level of lesion: T 10 to L 5, AIS A, classified by the American Spinal Injury Association (AISA)

Exclusion Criteria

  • •Acute decubitus in the stimulated area
  • •Arteriosclerosis
  • •Less than three months after flap surgery or after decubitus in the stimulated area
  • •Infections or skin eczema in the stimulated area

Outcomes

Primary Outcomes

Magnetic Resonance Imaging to determine the thickness of the gluteal muscle and fat tissue of the buttock.

Time Frame: 45 min.

Secondary Outcomes

  • Measuring of the seating pressure to determine the distribution of the middle and maximal seating pressure(15 min.)
  • Questionnaire on subjective wellbeing(10 min.)

Study Sites (1)

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