Effectiveness of Extra-corporeal Shockwave Diathermy in the Management of Upper Limb Function Patients With Stroke.

Effectiveness of Extra-corporeal Shockwave Diathermy in the Management of Upper Limb Function Patients With Stroke: Randomized Controlled Trial.

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.

Study Overview

• Status: Recruiting
• Conditions: Stroke
• Intervention / Treatment: Other: ESWT; Other: Stretching; Other: Mobility; Other: Strengthening; Other: Functional training

Detailed Description

Stroke is one of the leading causes of mortality and long-term disability, with millions of new cases each year and a large proportion of survivors living with lasting impairments in movement and function. After a stroke, damage to the motor areas and descending pathways of the brain frequently leads to spasticity, a condition in which muscles become abnormally tight and resist passive stretch; this increase in muscle tone is velocity-dependent and often accompanied by weakness and loss of selective control. Spasticity develops in a substantial proportion of stroke survivors and is especially disabling when it involves the upper limb, where it interferes with reaching, grasping, releasing, and the performance of essential activities of daily living such as dressing, feeding, and personal care.

Upper limb involvement is particularly common because most strokes affect the middle cerebral artery (MCA) territory, which supplies key regions of the motor cortex and internal capsule responsible for control of the face and arm more than the leg. As a result, many patients present with the characteristic pattern of flexor spasticity in the shoulder, elbow, wrist, and fingers, while the lower limb may show relatively better recovery or a different pattern of impairment. Recovery of upper limb function is also typically slower and less complete than that of the lower limb: walking often returns earlier, whereas fine hand and arm movements require more complex cortical processing and richer sensorimotor integration, which are more vulnerable to damage and harder to reorganize. This slower recovery reflects, in part, the lower effective neuroplasticity or more limited spontaneous re-organization in upper limb networks after stroke, meaning that more intensive, targeted, and often multimodal interventions are needed to restore arm and hand function.

Because of these factors, the upper limb frequently remains a limitation for independence even when a patient can walk, and persistent spasticity in the arm can further block functional gains by causing abnormal postures, contractures, and pain. Traditional approaches to spasticity management; such as oral antispastic medications and botulinum toxin injections can reduce muscle tone, but they often provide only temporary relief, may have systemic or local side effects, and do not always translate into meaningful functional improvements. These limitations have driven interest in innovative, non-invasive options that can modulate muscle tone and support neuroplasticity while fitting into comprehensive rehabilitation programs.

Extracorporeal shock wave therapy (ESWT) is one such emerging modality as it delivers controlled acoustic waves to targeted muscles and soft tissues and is thought to act through a combination of mechanical, vascular, and neuromodulator mechanisms. Experimental and clinical studies suggest that ESWT may reduce spasticity by altering reflex excitability, influencing neuromuscular junction function, and promoting tissue regeneration and remodeling, with reported side effects generally mild and transient. Early and mid-term clinical evidence indicates that ESWT can safely decrease spasticity and, in some trials, achieve functional gains comparable to more established treatments, but the exact mechanisms, optimal parameters (energy, frequency, number of shocks, treatment sites, and session frequency), and long-term functional impact are not yet fully defined.

This study focuses on the upper limb spasticity as it is the region where disability is often greatest, recovery is slowest, and current options are imperfect. By targeting key flexor muscle groups of the affected upper limb with ESWT, the aim is to reduce pathological muscle overactivity and spasticity, thereby creating a more favorable biomechanical and neurophysiological environment for active training and functional use. The study plan hypothesizes that systematically applied ESWT, integrated with structured rehabilitation, can meaningfully improve upper limb function in stroke, addressing a critical unmet need in post-stroke care and contributing evidence toward standardized, parameter-based ESWT protocols.

• Study Type: Interventional
• Enrollment (Estimated): 50
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Sharmila banu Ali, DPT; Phone Number: 1906 067031555; Email: sharmieashak@gmail.com
• Study Contact Backup: Name: Ramprasad Muthukrishnan, Phd/; Phone Number: 1551 +971 6 7431333; Email: mrp@gmu.ac.ae

Study Locations

• United Arab Emirates
  • Ajman Emirate
    • Ajman, Ajman Emirate, United Arab Emirates
      • Recruiting
      • Gulf Medical University
      • Contact: Dr. Ramprasad Muthukrishnan, Ph.D; Phone Number: 1551 971-555917250; Email: mrp@gmu.ac.ae
      • Contact: Sateesh Durairaj, PhD; Phone Number: 971-551808474

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion criteria:

1. Diagnosed as 1st stroke incidence 6 months back
2. Both male and female
3. Age 25 to 65 years
4. the ability to follow verbal instructions
5. Modified Ashworth Scale score 1-4

Exclusion criteria:

1. Recurrent stroke.
2. Severe contractures or deformities of upper extremity.
3. Chronic pain affecting upper extremity function.
4. malignant tumor, pacemakers, infection

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Experimental group; Participants 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.	Other: ESWT; 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); Other: Stretching; Sustained stretches held for 10 seconds, 3-5 repetitions per muscle group; Other: Mobility; Active and passive range of motion (ROM) exercises, 10-15 reps; Other: Strengthening; Isometric/ Isotonic exercises for antagonist muscles, 3 sets of 10-15 reps; Other: Functional training; Task-oriented activities ADLs. Eg: grasping, reaching, manipulation, 20-30 minutes per session
Sham Comparator: Control group; Participants 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.	Other: Stretching; Sustained stretches held for 10 seconds, 3-5 repetitions per muscle group; Other: Mobility; Active and passive range of motion (ROM) exercises, 10-15 reps; Other: Strengthening; Isometric/ Isotonic exercises for antagonist muscles, 3 sets of 10-15 reps; Other: Functional training; Task-oriented activities ADLs. Eg: grasping, reaching, manipulation, 20-30 minutes per session

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Electrical activation of muscle	Muscle activity will be objectively assessed using using the BTS, Electromyography (EMG) system to measure amplitude of root mean square (RMS) (µV).(3) RMS reflects the overall level at rest and during movement.The subject will be asked to be seated comfortably on a chair with his/her arm rested on a table, elbow extension at 110°-120°, and the wrist placed in the neutral position. The subject will be requested four motion patterns spherical grasp, hand opening, tripod pinch , and hook grip. Each movement will be performed 3 times in pair, for accuracy. During this process six EMG sensors will placed on the six muscles: flexor digitorum superficialis (FDS), flexor digitorum Profundus (FDP), medial head of extensor digitorum (EDM), lateral head of extensor digitorum (EDL), extensor pollicis longus (EPL), and extensor carpi radialis longus (ECR) muscle on the tested side.(3)	Baseline, post intervention (6 week), 1 month followup (10 weeks)
Muscles force generating capacity	Muscle's highest force-generating capacity during voluntary effort will be recorded with maximum voluntary contraction (MVC) (expressed as %).(3). The subject will be asked to follow the same EMG procedure denoted for recording the overall electrical activity of the muscle. Except in each pair of movement, one movement will be performed at maximum voluntary contraction (MVC) and the other one at comfortable force.	Baseline, post intervention (6 week), 1 month followup (10 weeks)

Collaborators and Investigators

• Sponsor: Gulf Medical University
• Investigators: Principal Investigator: Sharmila banu Ali, DPT/MPT, Thumbay Physical Therapy and Rehabilitation Hospital

Publications and helpful links

General Publications

• 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.
• Duan 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.
• Silverman 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.

Study record dates

Study Major Dates

• Study Start (Actual): October 30, 2025
• Primary Completion (Estimated): May 30, 2026
• Study Completion (Estimated): June 30, 2026

Study Registration Dates

• First Submitted: February 16, 2026
• First Submitted That Met QC Criteria: April 6, 2026
• First Posted (Actual): April 9, 2026

Study Record Updates

• Last Update Posted (Actual): April 9, 2026
• Last Update Submitted That Met QC Criteria: April 6, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: upperlimb funciton; extracarporal shockwave therapy
• Additional Relevant MeSH Terms: Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Stroke; Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena; Therapeutics; Diagnostic Techniques and Procedures; Diagnosis; Physical Therapy Modalities; Patient Care; Exercise Therapy; Rehabilitation; Aftercare; Continuity of Patient Care; Physical Conditioning, Human; Exercise; Physical Examination; Resistance Training; Range of Motion, Articular
• Other Study ID Numbers: IRB-COHS-FAC-57-Jan-2026

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No