Spinal Cord Injury Clinical Trial
Official title:
Clinical Pilot Study of the Effect of Electrical Stimulation of Denervated Muscles After Spinal Cord Injury
Verified date | November 2014 |
Source | Swiss Paraplegic Centre Nottwil |
Contact | n/a |
Is FDA regulated | No |
Health authority | Switzerland: Ethikkommission |
Study type | Interventional |
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.
Status | Terminated |
Enrollment | 5 |
Est. completion date | November 2014 |
Est. primary completion date | November 2014 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years to 70 Years |
Eligibility |
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 |
Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Switzerland | Swiss Paraplegic Centre | Nottwil | LU |
Lead Sponsor | Collaborator |
---|---|
Swiss Paraplegic Centre Nottwil |
Switzerland,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Magnetic Resonance Imaging to determine the thickness of the gluteal muscle and fat tissue of the buttock. | 45 min. | No | |
Secondary | Measuring of the seating pressure to determine the distribution of the middle and maximal seating pressure | 15 min. | No | |
Secondary | 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. | No |
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