Spinal Cord Injury
Conditions
Brief summary
The aim of the study is to investigate whether there is an effect of electrical stimulation on the denervated gluteus muscle (buttocks) in individuals with chronic spinal cord injury. The expected outcome is an increase in muscle volume and a better pressure distribution during sitting. The stimulation of the gluteus muscle is performed daily for 35 minutes over a period of six months. The muscle volume and the pressure distribution are measured before stimulation, three months after having started stimulation and after six months.
Interventions
DEVICEStimulette
electrical stimulation device by Dr. Schuhfried Medizintechnik GmbH, Vienna, Austria
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
* chronic spinal cord injury (min. 2 years after injury) * lesion height from T10-L5 * ASIA (American Spinal Cord Injury Association) Impairment Scale A
Exclusion criteria
* acute pressure sore in stimulated area (M. gluteus) * arteriosclerosis * skin irritation or infection in stimulated area (M. gluteus) * \< 3 months after plastic surgery in stimulated area (M. gluteus)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| change in muscle volume | day 0 to 3 months | determination of muscle volume using magnetic resonance images |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| change in quality of life | day 0 to 3months | questionnaire |
| change in muscle volume | 3 months to 6 months | determination of muscle volume using magnetic resonance images |
| change in sitting pressure | day 0 to 3 months | pressure mapping system |
Countries
Switzerland
Outcome results
None listed