Muscle Spasticity, Stroke
Conditions
Keywords
stroke, spasticity, shock wave, shoulder
Brief summary
Extracorporeal shock wave therapy (ESWT) has shown potential in reducing post-stroke limb spasticity. This study aims to evaluate the efficacy of focused ESWT on shoulder internal rotator spasticity in post-stroke patients.
Detailed description
This study aimed to evaluate the effects of focused extracorporeal shock wave therapy (ESWT) on shoulder internal rotator spasticity in stroke patients. Participants were randomized into two groups: an experimental group receiving targeted ESWT on specific shoulder internal rotators, and a control group receiving placebo treatments mimicking the shockwave therapy, with treatments administered twice weekly over two weeks for a total of four sessions. The efficacy of the treatment was measured using a comprehensive set of assessment tools, including range of motion, pain levels, spasticity scales, functional assessments, as well as measures of daily living activities, and ultrasound strain elastography. The outcomes were evaluated at multiple points in time: before treatment, and 1, 4, 12, and 24 weeks after the therapy concluded, to assess both immediate and sustained effects of the treatment on shoulder function and spasticity in stroke survivors.
Interventions
The focused shockwaves are directed at the affected muscles in the upper limb, specifically targeting the subscapularis, pectoralis major, latissimus dorsi, and teres major muscles.
Sponsors
National Taiwan University Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Masking description
Participant Care Provider Outcomes Assessor
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patients aged 18 years or older with unilateral cerebral stroke. * Restricted passive external rotation of the spastic shoulder by more than 20 degrees. * A Modified Ashworth Scale score of 1 or higher for shoulder internal rotator spasticity. * Stable medical condition and vital signs. * Clear consciousness, able to follow instructions.
Exclusion criteria
* History of two or more strokes, traumatic brain injury, brain tumors, or other cerebral disorders. * Coexisting central nervous system disorders (e.g., spinal cord injury, Parkinson's disease) or other musculoskeletal conditions affecting muscle tone assessment. * Ineligibility for shock wave intervention due to malignancies, coagulation disorders, localized infections, or presence of a pacemaker. * Prior shock wave intervention or botulinum toxin injection for post-stroke spasticity within the past three months. * Inability to participate in interventions or functional assessments due to cognitive, consciousness, or language impairments.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| passive range of motion for the shoulder joints | pre-treatment; 1, 4, 12, and 24 weeks post-treatment | the extent to which a joint can be moved without the patient actively participating in the movement |
| shoulder strength | pre-treatment; 1, 4, 12, and 24 weeks post-treatment | the muscle power generated by the shoulder muscles, quantified using the Medical Research Council (MRC) scale, which grades muscle strength from 0 (no visible contraction) to 5 (normal strength against full resistance) |
| Visual Analogue Scale (VAS) | pre-treatment; 1, 4, 12, and 24 weeks post-treatment | individuals rate their pain from 0 to 10, where 0 represents 'no pain' and 10 signifies 'the worst pain imaginable |
| modified Ashworth scale (MAS) | pre-treatment; 1, 4, 12, and 24 weeks post-treatment | Evaluate spasticity in individuals with neurological conditions. The scale ranges from 0, indicating no increase in muscle tone, to 4, which represents severe spasticity with affected parts rigid in flexion or extension. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Fugl-Meyer Assessment for the Upper Extremity (FMA-UE) | pre-treatment; 1, 4, 12, and 24 weeks post-treatment | range from 0 (complete paralysis) to 66 (full function), assessing motor recovery in post-stroke upper extremities |
| ultrasound assessment | pre-treatment; 1, 4, 12, and 24 weeks post-treatment | used strain elastography to assess elasticity of shoulder muscles |
| Action Research Arm Test (ARAT) | pre-treatment; 1, 4, 12, and 24 weeks post-treatment | a standardized measure evaluating upper limb motor ability in stroke patients, scoring from 0 (no movement) to 57 (normal arm function). It assesses grasp, grip, pinch, and gross arm movement. |
| Barthel index | pre-treatment; 1, 4, 12, and 24 weeks post-treatment | measures a person's daily living abilities, focusing on ten areas of self-care and mobility. Scores range from 0 to 100, with higher scores denoting greater independence. |
| Wolf Motor Function Test | pre-treatment; 1, 4, 12, and 24 weeks post-treatment | assess upper extremity function in individuals with neurological impairments, using 17 tasks divided into sections of time, functional ability, and strength. Scoring is on a 6-point ordinal scale, ranging from 0 (Does not attempt with upper extremity being tested, indicating severe impairment) to 5 (Movement appears to be normal, suggesting full functionality). Lower scores indicate greater impairment. |
Countries
Taiwan
Contacts
Primary ContactShu-mei Yang, MD
Outcome results
None listed