Health Trialsby

FlexWave Trial: Efficacy of Extracorporeal Shock Wave Therapy in Post-Stroke Upper Limb Spasticity

ConditionsStroke Spasticity, Muscle

Trial statusRecruiting

Trial phaseNot applicable

Trial typeInterventional

Biological sexAll

Age18+

SponsorNational Taiwan University Hospital

About this trial

Extracorporeal shock wave therapy (ESWT) has emerged as an effective therapeutic intervention for addressing post-stroke limb spasticity. This research aims to explore the therapeutic implications of focused ESWT for wrist and finger flexor muscles in patients suffering from post-stroke upper limb spasticity.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Individuals aged 18 years or older with unilateral cerebral stroke.

Wrist and finger flexor muscle tone with a score greater than 1 on the Modified Ashworth Scale.

Stable medical condition and vital signs.

Conscious and able to comply with instructions.

Disqualifiers

History of more than one stroke, traumatic brain injury, or cerebral neoplasm.

Coexisting central nervous system disorders (e.g., spinal cord injury, Parkinson's disease) or other musculoskeletal diseases affecting muscle tone assessment.

Contraindications for shockwave intervention, such as malignancies, coagulopathies, local infections, or use of cardiac pacemakers.

Undergone shockwave therapy or botulinum toxin injections for post-stroke spasticity in 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 flexor carpi ulnaris, flexor carpi radialis, and flexor digitorum superficialis.

Treatment groups

40 Participants

are divided into 2 treatment groups

Group A: Focused Extracorporeal Shock Wave TherapyExperimental treatment 1 intervention

Group B: Placebo-Controlled Shockwave TherapyPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

passive range of motion for the wrist and finger 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

hand grip strength

use dynamometer to record the maximum force applied when the patient squeezes it

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

Functional Independence Measure (FIM)

assesses a patient's level of disability and tracks changes over time, with a focus on physical and cognitive functioning across 18 items, scored from 18 (total assistance required) to 126 (fully independent).

Time frame

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

Locations

1

Map coordinates are unavailable for these locations. Locations are shown below instead.

Department of Physical Medicine & Rehabilitation , National Taiwan University HospitalRecruiting100, Taipei, Taipei Taiwan

Taiwan

Taiwan

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

National Taiwan University Hospital

Lead sponsor

Source ClinicalTrials.gov