Effectiveness of Extra-corporeal Shockwave Diathermy in the Management of Upper Limb Function Patients With Stroke.
1 other identifier
interventional
50
1 country
1
Brief Summary
Stroke is a leading cause of death and disability worldwide. A major complication of stroke is spasticity, marked by increased muscle tone and impaired movement. It affects majority stroke patients and complicates rehabilitation, affecting the upper limb function of survivors. While traditional treatments like oral medications and botulinum toxin injections offer some relief, they have notable limitations, causing the need for novel, non-invasive approaches. Extracorporeal shock wave therapy (ESWT), which uses acoustic waves for regeneration and neuromodulation, has shown promise in reducing spasticity with minimal side effects, though its precise mechanisms and ideal protocols need further study. Current evidence supports ESWT's efficacy and safety, often matching established treatments, but gaps remain regarding standardized application and long-term functional outcomes, highlighting the need for more robust research.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable stroke
Started Oct 2025
Shorter than P25 for not_applicable stroke
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 30, 2025
CompletedFirst Submitted
Initial submission to the registry
February 16, 2026
CompletedFirst Posted
Study publicly available on registry
April 9, 2026
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 30, 2026
CompletedStudy Completion
Last participant's last visit for all outcomes
June 30, 2026
ExpectedApril 9, 2026
April 1, 2026
7 months
February 16, 2026
April 6, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Upper limb function test
The upper limb function will be evaluated using the Neofect Smart Board test. The test will involve three different kinematic assessment programs: free exploration, point-to-point reaching, and circle-drawing.Data will be recorded as time taken to complete the evaluation (s) then the average of three tasks will serve to denote the upperlimb function. Each assessment program has a time limit of 60 s. (2)
Baseline, post intervention (6 week), 1 month followup (10 weeks)
Secondary Outcomes (2)
Electrical activation of muscle
Baseline, post intervention (6 week), 1 month followup (10 weeks)
Muscles force generating capacity
Baseline, post intervention (6 week), 1 month followup (10 weeks)
Study Arms (2)
Experimental group
EXPERIMENTALParticipants randomized in to experimental group will receive Extra-corporeal Shockwave therapy applied to the spastic upper limb muscles along with conventional upper limb physiotherapy program.
Control group
SHAM COMPARATORParticipants randomized in to control group will receive sham Extra-corporeal Shockwave therapy applied to the spastic upper limb muscles along with conventional upper limb physiotherapy program.
Interventions
Target muscles: biceps brachii, flexor carpi radialis, pronator teres, wrist and finger flexors. Protocol: 2000 shocks per muscle per session, energy flux density 0.03 mJ/mm², frequency 8 Hz, pressure \~0.2 MPa (2 bars).(1)
Sustained stretches held for 10 seconds, 3-5 repetitions per muscle group
Active and passive range of motion (ROM) exercises, 10-15 reps
Isometric/ Isotonic exercises for antagonist muscles, 3 sets of 10-15 reps
Task-oriented activities ADLs. Eg: grasping, reaching, manipulation, 20-30 minutes per session
Eligibility Criteria
You may qualify if:
- Diagnosed as 1st stroke incidence 6 months back
- Both male and female
- Age 25 to 65 years
- the ability to follow verbal instructions
- Modified Ashworth Scale score 1-4
You may not qualify if:
- Recurrent stroke.
- Severe contractures or deformities of upper extremity.
- Chronic pain affecting upper extremity function.
- malignant tumor, pacemakers, infection
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Gulf Medical University
Ajman, Ajman Emirate, United Arab Emirates
Related Publications (3)
Park M, Ko MH, Oh SW, Lee JY, Ham Y, Yi H, Choi Y, Ha D, Shin JH. Effects of virtual reality-based planar motion exercises on upper extremity function, range of motion, and health-related quality of life: a multicenter, single-blinded, randomized, controlled pilot study. J Neuroeng Rehabil. 2019 Oct 24;16(1):122. doi: 10.1186/s12984-019-0595-8.
BACKGROUNDDuan H, Lian Y, Jing Y, Xing J, Li Z. Research progress in extracorporeal shock wave therapy for upper limb spasticity after stroke. Front Neurol. 2023 Feb 9;14:1121026. doi: 10.3389/fneur.2023.1121026. eCollection 2023.
BACKGROUNDSilverman JD, Balbinot G, Masani K, Zariffa J, Eng P. Validity and Reliability of Surface Electromyography Features in Lower Extremity Muscle Contraction in Healthy and Spinal Cord-Injured Participants. Top Spinal Cord Inj Rehabil. 2021 Fall;27(4):14-27. doi: 10.46292/sci20-00001. Epub 2021 Feb 8.
PMID: 34866885BACKGROUND
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Sharmila banu Ali, DPT/MPT
Thumbay Physical Therapy and Rehabilitation Hospital
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 16, 2026
First Posted
April 9, 2026
Study Start
October 30, 2025
Primary Completion
May 30, 2026
Study Completion (Estimated)
June 30, 2026
Last Updated
April 9, 2026
Record last verified: 2026-04
Data Sharing
- IPD Sharing
- Will not share