SIRS-ESWT Trial: Shoulder Internal Rotator Spasticity Trial Treated With Extracorporeal Shock Wave Therapy Trial
- Conditions
- StrokeMuscle Spasticity
- Registration Number
- NCT06674785
- Lead Sponsor
- National Taiwan University Hospital
- 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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 40
- 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.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method 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
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.
ultrasound assessment pre-treatment; 1, 4, 12, and 24 weeks post-treatment used strain elastography to assess elasticity of shoulder muscles
Trial Locations
- Locations (1)
Department of Physical Medicine & Rehabilitation , National Taiwan University Hospital
🇨🇳Taipei, Taiwan