Effects of Extracorporeal Shock Wave Therapy on Shoulder Internal Rotator Spasticity in Post-Stroke Patients: A Randomized Controlled Trial
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Stroke
- Sponsor
- National Taiwan University Hospital
- Enrollment
- 40
- Locations
- 1
- Primary Endpoint
- passive range of motion for the shoulder joints
- Status
- Recruiting
- Last Updated
- 9 months ago
Overview
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.
Investigators
Eligibility Criteria
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.
Outcomes
Primary Outcomes
passive range of motion for the shoulder joints
Time Frame: 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
Time Frame: 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)
Time Frame: 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)
Time Frame: 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 Outcomes
- Fugl-Meyer Assessment for the Upper Extremity (FMA-UE)(pre-treatment; 1, 4, 12, and 24 weeks post-treatment)
- Action Research Arm Test (ARAT)(pre-treatment; 1, 4, 12, and 24 weeks post-treatment)
- Barthel index(pre-treatment; 1, 4, 12, and 24 weeks post-treatment)
- Wolf Motor Function Test(pre-treatment; 1, 4, 12, and 24 weeks post-treatment)
- ultrasound assessment(pre-treatment; 1, 4, 12, and 24 weeks post-treatment)