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

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON29014

Enrollment

Registered

2020-09-09

Start date

2020-10-19

Completion date

Unknown

Last updated

2024-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

• spinal cord injury (ASIA / AIS score C or D) • Spastic paresis / paralysis in the calf or wrist / hand region

Interventions

During this study (featuring a multiple single case experimental design (A-B-A) with a randomized intervention starting point) a five patients are treated in the wrist / hand region and five patients

Eligibility

Inclusion criteria

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

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.

Design outcomes

Primary

Measure	Time frame
An improvement in the performance of specific ADL tasks for the upper or lower extremities is measured using the Goal Attainment Scaling (GAS).	—

Secondary

Measure	Time frame
Secondary outcome measures are: • Active range of motion (AROM) • Passive range of motion (PROM) • 10 meter walk test (10MLT) • Pain perception in the treatment area (VAS) • Short version of the Van Lieshout arm dexterity test for Tetraplegia (VLT-sf) that will be reported descriptively.	—

Contacts

Public ContactBoris Hellenbrand

Adelante Zorggroep

b.hellenbrand@adelante-zorggroep.nl+31.(0)45 5282828

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)