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Clinical Trials/NCT04312581
NCT04312581
Completed
Not Applicable

Effect of Extracorporeal Shock Wave Therapy on Wrist and Hand Functions in Spastic Chronic Stroke Patients :Randomized Controlled Study

Tanta University1 site in 1 country40 target enrollmentMarch 21, 2020

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Stroke
Sponsor
Tanta University
Enrollment
40
Locations
1
Primary Endpoint
Hmax / Mmax amplitude ratio
Status
Completed
Last Updated
5 years ago

Overview

Brief Summary

40 chronic stroke patients with upper limb spasticity will randomly divided into two groups. First group will receive 3 sessions of radial extracorporeal shock wave therapy (rESWT) with one week apart without cessation of current physical therapy, while the second group will continue to receive conventional rehabilitative program.

Assessment will be done at baseline, 2 weeks after rESWT and 3 months after rESWT using Modified Ashworth Scale, Fugl Meyer Assessment for hand function and wrist control, motricity index for pinch grip and Hmax/ Mmax amplitude ratio of flexor carpi radialis muscle.

Registry
clinicaltrials.gov
Start Date
March 21, 2020
End Date
July 29, 2020
Last Updated
5 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

samar abd alhamed tabra

Principal Investigator

Tanta University

Eligibility Criteria

Inclusion Criteria

  • Patients with chronic stroke with disease duration more than one year will be included in the study with stable modified Ashworth scale for upper limb spasticity ranged from 1+ to 4.

Exclusion Criteria

  • Patients more than 65 years,Patients with double stroke and patients with fixed contractures of wrist \& hand ,Patients received anti-spastic measures (botulinum toxins, nerve block) within 6 months,Also patients with contraindication to extra-corporeal shock wave therapy i.e. malignancy at treatment area, coagulopathies, active infection (viral or TB), o bleeding wounds, and patients with pacemakers will be excluded

Outcomes

Primary Outcomes

Hmax / Mmax amplitude ratio

Time Frame: Change from Pre to Post 1 [after 3rd session (after 2 weeks from baseline) ] and Post 2 (3 months follow-up)

H reflex is an electrically triggered spinal reflex with a fairly constant latency and amplitude on repeated testing.Hmax / Mmax amplitude ratio was obtained from patient's spastic upper limb, flexor carpi radials muscle

Modified Ashworth Scale

Time Frame: Change from Pre to Post 1 [after 3rd session (after 2 weeks from baseline) ] and Post 2 (3 months follow-up)

is a valid scoring system for spasticity

Fugl-Meyer Assessment

Time Frame: Change from Pre to Post 1 [after 3rd session (after 2 weeks from baseline) ] and Post 2 (3 months follow-up)

reliable assessment tool for sensorimotor function of the upper extremity of stroke patients

Motricity Index

Time Frame: Change from Pre to Post 1 [after 3rd session (after 2 weeks from baseline) ] and Post 2 (3 months follow-up)

used to assess the motor impairment in a patient with stroke, only one item (pinch grip) was tested using a 2.5 cm cube between the thumb and forefinger * 19 points are given if able to grip cube but not hold it against gravity * 22 points are given if able to hold cube against gravity but not against a weak pull * 26 points are given if able to hold the cube against a weak pull but strength is weaker than normal

Study Sites (1)

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