Functional added value of shockwave therapy in persons with a spinal cord injury and spasticity: a multiple single case experimental design study
- Conditions
- • spinal cord injury (ASIA / AIS score C or D)• Spastic paresis / paralysis in the calf or wrist / hand region
- Registration Number
- NL-OMON29014
- Lead Sponsor
- Adelante Zorggroep
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- Not specified
- Target Recruitment
- 10
• Diagnosed with a spinal cord injury (ASIA / AIS score C or D) for more than 6 months.
• Spastic paresis / paralysis in the calf or wrist / hand region (MAS score = 1+).
• Age =18 years.
• No additional orthopedic, rheumatological or neurological co-morbidity that can obscure the answer to the research question.
• No cognitive problems that hinder the participant's understanding of the assignments during the research.
• Adequate knowledge of the Dutch language, i.e. being able to understand the (measurement) assignments.
• Being able to walk 10 meters; regarding ESWT of the calf region.
• Being able to, at least, operate an electric wheelchair with the arm in question; regarding ESWT of the wrist / hand region.
• Pregnancy.
• Tumor.
• Osteoporosis.
• Thrombosis.
• Polyneuropathy in diabetes.
• Neuromuscular disorders.
• Metal implants in the area to be treated.
• Infection or inflammation of the skin area to be treated.
• Oral anticoagulation medication like coumarine derivatives, DOAC’s or NOAC’s.
• administration of a BoNT injection in the area to be treated within the past 4 months.
• Cortisone therapy up to 6 weeks before the first treatment.
• Pacemaker or electronic implants.
• An intrathecal Baclofen pump.
• Presence of contractures where a reduction in spasticity does not show an improvement in passive range of motion (PROM) in the area to be treated
• No informed consent.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method An improvement in the performance of specific ADL tasks for the upper or lower extremities is measured using the Goal Attainment Scaling (GAS).
- Secondary Outcome Measures
Name Time Method Secondary outcome measures are: <br>• Active range of motion (AROM)<br>• Passive range of motion (PROM)<br>• 10 meter walk test (10MLT)<br>• Pain perception in the treatment area (VAS)<br>• Short version of the Van Lieshout arm dexterity test for Tetraplegia (VLT-sf) that will be reported descriptively.