SIRS-ESWT Trial: Shoulder Internal Rotator Spasticity Trial Treated With Extracorporeal Shock Wave Therapy Trial

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorNational Taiwan University Hospital

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 volunteers

Qualifiers

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

Design model

Parallel

Treatments tested in this trial

  • focused extracorporeal shock wave therapy (ESWT)

    Device

    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.

  • focused extracorporeal shock wave therapy (ESWT)

    Device

    Placebo shockwave therapy directed at subscapularis, pectoralis major, latissimus dorsi, and teres major muscles.

Treatment groups

40 Participants
are divided into 2 treatment groups
Group A: Focused Extracorporeal Shock WaveExperimental treatment 1 intervention
Group B: Placebo-Controlled Shockwave TherapyPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

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

Time frame
pre-treatment; 1, 4, 12, and 24 weeks post-treatment
2

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)

Time frame
pre-treatment; 1, 4, 12, and 24 weeks post-treatment
3

Visual Analogue Scale (VAS)

individuals rate their pain from 0 to 10, where 0 represents 'no pain' and 10 signifies 'the worst pain imaginable

Time frame
pre-treatment; 1, 4, 12, and 24 weeks post-treatment
4

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.

Time frame
pre-treatment; 1, 4, 12, and 24 weeks post-treatment

Secondary outcomes

1

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

Time frame
pre-treatment; 1, 4, 12, and 24 weeks post-treatment
2

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.

Time frame
pre-treatment; 1, 4, 12, and 24 weeks post-treatment
3

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.

Time frame
pre-treatment; 1, 4, 12, and 24 weeks post-treatment
4

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.

Time frame
pre-treatment; 1, 4, 12, and 24 weeks post-treatment

Other outcomes

Sponsors and contacts

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