About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial design
Parallel
Treatments tested in this trial
focused extracorporeal shock wave therapy (ESWT)
DeviceThe focused shockwaves are directed at the affected muscles in the upper limb, specifically targeting the subscapularis, pectoralis major, latissimus dorsi, and teres major muscles.
focused extracorporeal shock wave therapy (ESWT)
DevicePlacebo shockwave therapy directed at subscapularis, pectoralis major, latissimus dorsi, and teres major muscles.
Treatment groups
Trial outcomes
Primary outcomes
passive range of motion for the shoulder joints
the extent to which a joint can be moved without the patient actively participating in the movement
shoulder strength
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)
individuals rate their pain from 0 to 10, where 0 represents 'no pain' and 10 signifies 'the worst pain imaginable
modified Ashworth scale (MAS)
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)
range from 0 (complete paralysis) to 66 (full function), assessing motor recovery in post-stroke upper extremities
Action Research Arm Test (ARAT)
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
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
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.
Sponsors and contacts
Click on the lead sponsor to view all of their trials.