Extracorporeal Shock Wave Therapy on Wrist and Hand Functions in Spastic Chronic Stroke Patients

Not Applicable

Completed

• Conditions: Spasticity; Shock Wave; Stroke
• Interventions: Device: Extracorporeal shock wave therapy; Other: Conventional rehabilitation

• Registration Number: NCT04312581
• Lead Sponsor: Tanta University

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-03-12
• Study First Submitted QC: 2020-03-16
• Study First Posted: 2020-03-18
• Study Start: 2020-03-21
• Primary Completion: 2020-07-29
• Study Completion: 2020-07-29
• Status Verified: 2020-08
• Last Update Submitted: 2020-08-29
• Last Update Posted: 2020-09-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
First group (shock wave)	Extracorporeal shock wave therapy	Extracorporeal shock wave therapy
Second group (conventional rehabilitation)	Conventional rehabilitation	conventional rehabilitation

Primary Outcome Measures

Name	Time	Method
Hmax / Mmax amplitude ratio	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	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	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	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

Trial Locations

Locations (1)

Tanta university hospital; 🇪🇬 Tanta, Gharbia, Egypt