Electrical Stimulation of Denervated Muscles After Spinal Cord Injury

Study Overview
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Brief Summary
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In this study the following hypotheses will be tested: Electrical stimulation of the gluteal muscle (buttocks) leads to an increase in the thickness of the gluteal muscle a decrease in the thickness of the fat of the buttock area a change in the distribution of the middle and maximal seating pressure to a more consistent pressure an increase in well-being of the patients.

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

Conditions
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Spinal Cord Injury

Intervention / Treatment
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* Device: Electrical Stimulation


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Electrical Stimulation<br> | Device: Electrical Stimulation<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Magnetic Resonance Imaging to determine the thickness of the gluteal muscle and fat tissue of the buttock. |  | 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 |  | 15 min. | 
| Questionnaire on subjective wellbeing | 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. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Spinal Cord Injury, Denervation, Electrical Stimulation