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

Sponsor
Tanta University (Other)
Overall Status
Completed
CT.gov ID
NCT04312581
Collaborator
(none)
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Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Device: Extracorporeal shock wave therapy
  • Other: Conventional rehabilitation
N/A

Study Design

Study Type:
Interventional
Actual Enrollment :
40 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Investigator, Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
Effect of Extracorporeal Shock Wave Therapy on Wrist and Hand Functions in Spastic Chronic Stroke Patients :Randomized Controlled Study
Actual Study Start Date :
Mar 21, 2020
Actual Primary Completion Date :
Jul 29, 2020
Actual Study Completion Date :
Jul 29, 2020

Arms and Interventions

Arm Intervention/Treatment
Experimental: First group (shock wave)

Extracorporeal shock wave therapy

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.

Active Comparator: Second group (conventional rehabilitation)

conventional rehabilitation

Other: Conventional rehabilitation
physical & occupational therapy

Outcome Measures

Primary Outcome Measures

  1. 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

  2. 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

  3. 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

  4. 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

Eligibility Criteria

Criteria

Ages Eligible for Study:
20 Years to 65 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Tanta university hospital Tanta Gharbia Egypt 31527

Sponsors and Collaborators

  • Tanta University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

Publications

None provided.
Responsible Party:
samar abd alhamed tabra, Principal Investigator, Tanta University
ClinicalTrials.gov Identifier:
NCT04312581
Other Study ID Numbers:
  • 101
First Posted:
Mar 18, 2020
Last Update Posted:
Sep 1, 2020
Last Verified:
Aug 1, 2020
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by samar abd alhamed tabra, Principal Investigator, Tanta University
Additional relevant MeSH terms:

Study Results

No Results Posted as of Sep 1, 2020