Functional added value of shockwave therapy in persons with a spinal cord injury and spasticity: a multiple single case experimental design study

Completed

Conditions: spasticity
spinal cord injury
10041543
10028302

Registration Number: NL-OMON55078

Lead Sponsor: Adelante Zorggroep

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 10

Inclusion Criteria

* 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.

Exclusion Criteria

* 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
<p>An improvement in the performance of specific ADL tasks for the upper or lower<br /><br>extremities is measured using the Goal attainment Scaling (GAS).</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Secondary outcome measures are: active range of motion (AROM), passive range of<br /><br>motion (PROM), 10 meter walk test (10MLT), pain perception in the treatment<br /><br>area (VAS) and the short version of the Van Lieshout arm dexterity test for<br /><br>Tetraplegia (VLT-sf) that will be reported descriptively.</p><br>