Aim of the study is to ascertain the order of magnitude to which ESWT may improve the performance of specific activities of daily living (ADL), measured by Goal Entertainment Scaling (GAS) in people with spinal cord injury and spasticity in the…
ID
Source
Brief title
Condition
- Muscle disorders
- Spinal cord and nerve root disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
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
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) and the short version of the Van Lieshout arm dexterity test for
Tetraplegia (VLT-sf) that will be reported descriptively.
Background summary
About 65-78% of people with spinal cord injury develop spasticity. In general,
27-40% of the spinal cord injury population find spasticity problematic and
functionally impairing. In (multi) focal spasticity, Botulinum toxin (BoNT),
peripheral nerve blocks and surgery are used. A new application is
extracorporeal shockwave therapy (ESWT). This therapy is considered a safe,
effective, practical and non-invasive method to reduce spasticity without
causing muscle weakness or unpleasant experiences. Studies in recent years show
that ESWT is a safe way of treating people with (multi) focal spasticity. These
studies were done in people with Cerebral Palsy (CP), Cerebro Vascular Accident
(CVA) and Multiple Sclerosis (MS). ESWT has not yet been used in people with
spinal cord injury.
Study objective
Aim of the study is to ascertain the order of magnitude to which ESWT may
improve the performance of specific activities of daily living (ADL), measured
by Goal Entertainment Scaling (GAS) in people with spinal cord injury and
spasticity in the chronic phase.
Study design
In this study, a multiple single case experimental design (A-B-A) with a
randomized intervention starting point is used.
Intervention
During the intervention period, 5 patients are treated in the wrist / hand
region and 5 patients in the calf region. In a time period of 3 weeks, each
patient receives 3 ESWT treatment sessions of (on average) 10 minutes, with an
intermediate period of at least 6 days.
Study burden and risks
Administration of the ESWT may reduce the symptoms of calf or wrist / hand
spasticity, enabling the patient to perform several ADL tasks better. A
rehabilitation physician assesses the medical indication for the administration
of ESWT. While participating in the study, the patient should not receive BoNT
or change spasm medications (dose). Also, the patient must undergo some
measurements that would be less frequent without participating in this study.
These measuring instruments belong to the *standard* measuring instruments of
physiotherapy or rehabilitation. Studies in recent years show that ESWT is a
safe way of treating people with (multi) focal spasticity. These studies were
done in people with Cerebral Palsy (CP), Cerebro Vascular Accident (CVA) and
Multiple Sclerosis (MS). However, such study has not yet been performed in
people with a spinal cord injury. It is a non-invasive method of treatment
without muscle weakness or unpleasant experiences. The ESWT is only applied in
the chronic phase after a spinal cord injury, so the ESWT does not hinder the
(prior) rehabilitation process.
Zandbergsweg 111
Hoensbroek 6432CC
NL
Zandbergsweg 111
Hoensbroek 6432CC
NL
Listed location countries
Age
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.
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL73561.015.20 |
| Other | Studie zal na METC goedkeuring nog bij NTR geregistreerd worden |