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

Stroke Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04312581
• Other study ID #: 101
• Status: Completed
• Phase: N/A
• Start date: March 21, 2020
• Est. completion date: July 29, 2020

Study information

• Verified date: August 2020
• Source: Tanta University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: July 29, 2020
• Est. primary completion date: July 29, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Shock
• Shock Wave
• Spasticity
• Stroke

Intervention

Device:
• Extracorporeal shock wave therapy
3 sessions of radial- extracorporeal shock wave therapy rESWT one week apart, 2000-3000 impulses at 0.25-0.84 millijoule /mm2with a pressure 2.8 bar and 15 Hz frequency.

Other:
• Conventional rehabilitation
physical & occupational therapy

Locations

Country	Name	City	State
Egypt	Tanta university hospital	Tanta	Gharbia

Sponsors (1)

Lead Sponsor	Collaborator
Tanta University

Country where clinical trial is conducted

Egypt, 

References & Publications (1)

Li TY, Chang CY, Chou YC, Chen LC, Chu HY, Chiang SL, Chang ST, Wu YT. Effect of Radial Shock Wave Therapy on Spasticity of the Upper Limb in Patients With Chronic Stroke: A Prospective, Randomized, Single Blind, Controlled Trial. Medicine (Baltimore). 20 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Modified Ashworth Scale	is a valid scoring system for spasticity	Change from Pre to Post 1 [after 3rd session (after 2 weeks from baseline) ] and Post 2 (3 months follow-up)
Primary	Fugl-Meyer Assessment	reliable assessment tool for sensorimotor function of the upper extremity of stroke patients	Change from Pre to Post 1 [after 3rd session (after 2 weeks from baseline) ] and Post 2 (3 months follow-up)
Primary	Motricity Index	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	Change from Pre to Post 1 [after 3rd session (after 2 weeks from baseline) ] and Post 2 (3 months follow-up)
Primary	Hmax / Mmax amplitude ratio	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	Change from Pre to Post 1 [after 3rd session (after 2 weeks from baseline) ] and Post 2 (3 months follow-up)

External Links

•   Effect of Radial Shock Wave Therapy on Spasticity of the Upper Limb in Patients With Chronic Stroke