Electrical Stimulation of Denervated Muscles After Spinal Cord Injury

November 19, 2014 updated by: Swiss Paraplegic Centre Nottwil

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

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

5

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Switzerland
    • LU
      • Nottwil, LU, Switzerland, 6207
        • Swiss Paraplegic Centre

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Electrical Stimulation
Device: Electrical Stimulation

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Magnetic Resonance Imaging to determine the thickness of the gluteal muscle and fat tissue of the buttock.
Time Frame: 45 min.
45 min.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Measuring of the seating pressure to determine the distribution of the middle and maximal seating pressure
Time Frame: 15 min.
15 min.
Questionnaire on subjective wellbeing
Time Frame: 10 min.
The subjective effect of the electric stimulation will be assessed by an 5-item-questionnaire. Since no standardised questionnaire is available to assess the well-being in relation to sitting in a wheelchair, an individual non-validated questionnaire has been developed. It contains five questions: Question 1 and 2 address the number of resting phases while lying down and the respective overall duration of decompression each day. The questions 3 to 5 focus on the fear of pressure sores while sitting, every day limitations based on decompression phases and the subjective well-being while sitting in a wheelchair. The subjects answer the questions using a visual analog scale of 10 cm, indicating 0=no fear/no impairment/no well-being; 10=high fear/high impairment/high well-being. The subjects complete the questionnaire at baseline (start of intervention), after three and after six months.
10 min.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Swiss Paraplegic Centre Nottwil

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2012

Primary Completion (Actual)

November 1, 2014

Study Completion (Actual)

November 1, 2014

Study Registration Dates

First Submitted

February 24, 2014

First Submitted That Met QC Criteria

March 4, 2014

First Posted (Estimate)

March 6, 2014

Study Record Updates

Last Update Posted (Estimate)

November 20, 2014

Last Update Submitted That Met QC Criteria

November 19, 2014

Last Verified

November 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2012-13

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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