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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-04-15

Study Completion Date

2027-04-15

Brief Summary

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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.

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Detailed Description

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This study aimed to evaluate the effects of focused Extracorporeal Shock Wave Therapy (ESWT) on upper limb flexor spasticity in stroke patients. Participants were randomized into two groups: an experimental group receiving targeted ESWT on specific forearm flexor muscles, 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, hand grip strength, pain levels, spasticity scales, functional assessments, as well as measures of daily living activities, ultrasound strain elastography, and electromyography. 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 upper limb function and spasticity in stroke survivors.

Conditions

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Stroke Spasticity, Muscle

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Outcome Assessors

Study Groups

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Focused Extracorporeal Shock Wave Therapy

Participants in this arm will receive focused Extracorporeal Shock Wave Therapy (ESWT) targeting three specific muscles: the flexor carpi ulnaris, flexor carpi radialis, and flexor digitorum superficialis. Each muscle will receive 1,500 shockwave shots per session, accumulating to a total of 4,500 shots across all targeted muscles in each session. The treatment will be administered twice a week for two consecutive weeks, resulting in a total of four treatment sessions.

Group Type EXPERIMENTAL

focused extracorporeal shock wave therapy (ESWT)

Intervention Type 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.

Placebo-Controlled Shockwave Therapy

Participants in this arm will receive placebo-controlled focused ESWT, mirroring the treatment protocol of the experimental group but without the application of active shockwaves.

Group Type PLACEBO_COMPARATOR

focused extracorporeal shock wave therapy (ESWT)

Intervention Type 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.

Interventions

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focused extracorporeal shock wave therapy (ESWT)

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.

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* 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.

Exclusion Criteria

* 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.
* Cognitive, consciousness, or language impairments preventing participation in the intervention or functional assessments.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No