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

ConditionStroke
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-65
SponsorGulf Medical University

About this 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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Diagnosed as 1st stroke incidence 6 months back

Both male and female

Age 25 to 65 years

the ability to follow verbal instructions

Disqualifiers

Recurrent stroke.

Severe contractures or deformities of upper extremity.

Chronic pain affecting upper extremity function.

malignant tumor, pacemakers, infection

Trial design

Design model

Parallel

Treatments tested in this trial

  • ESWT

    Other intervention

    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)

  • Stretching

    Other intervention

    Sustained stretches held for 10 seconds, 3-5 repetitions per muscle group

  • Mobility

    Other intervention

    Active and passive range of motion (ROM) exercises, 10-15 reps

  • Strengthening

    Other intervention

    Isometric/ Isotonic exercises for antagonist muscles, 3 sets of 10-15 reps

  • Functional training

    Other intervention

    Task-oriented activities ADLs. Eg: grasping, reaching, manipulation, 20-30 minutes per session

Treatment groups

50 Participants
are divided into 2 treatment groups
Group A: Experimental groupExperimental treatment 5 interventions
Group B: Control groupSham comparator 4 interventions

Trial outcomes

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)

Time frame
Baseline, post intervention (6 week), 1 month followup (10 weeks)

Secondary outcomes

1

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)

Time frame
Baseline, post intervention (6 week), 1 month followup (10 weeks)
2

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.

Time frame
Baseline, post intervention (6 week), 1 month followup (10 weeks)

Other outcomes

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