Spinal Cord Injury
Conditions
Keywords
Spinal Cord Injury, Denervation, Electrical Stimulation
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.
Interventions
DEVICEElectrical Stimulation
Sponsors
Swiss Paraplegic Research, Nottwil
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Magnetic Resonance Imaging to determine the thickness of the gluteal muscle and fat tissue of the buttock. | 45 min. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Measuring of the seating pressure to determine the distribution of the middle and maximal seating pressure | 15 min. | — |
| Questionnaire on subjective wellbeing | 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. |
Countries
Switzerland
Outcome results
None listed