Back to resultsExtracorporeal Shock Wave Therapy on Wrist and Hand Functions in Spastic Chronic Stroke Patients
Primary Purpose
Stroke, Spasticity, Shock Wave
Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Extracorporeal shock wave therapy
Conventional rehabilitation
Sponsored by
About this trial
This is an interventional treatment trial for Stroke focused on measuring shock wave
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
Sites / Locations
- Tanta university hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
First group (shock wave)
Second group (conventional rehabilitation)
Arm Description
Extracorporeal shock wave therapy
conventional rehabilitation
Outcomes
Primary Outcome Measures
Modified Ashworth Scale
is a valid scoring system for spasticity
Fugl-Meyer Assessment
reliable assessment tool for sensorimotor function of the upper extremity of stroke patients
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
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
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04312581
Brief Title
Extracorporeal Shock Wave Therapy on Wrist and Hand Functions in Spastic Chronic Stroke Patients
Official Title
Effect of Extracorporeal Shock Wave Therapy on Wrist and Hand Functions in Spastic Chronic Stroke Patients :Randomized Controlled Study
Study Type
Interventional
2. Study Status
Record Verification Date
August 2020
Overall Recruitment Status
Completed
Study Start Date
March 21, 2020 (Actual)
Primary Completion Date
July 29, 2020 (Actual)
Study Completion Date
July 29, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Tanta University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke, Spasticity, Shock Wave
Keywords
shock wave
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
InvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
40 (Actual)
8. Arms, Groups, and Interventions
Arm Title
First group (shock wave)
Arm Type
Experimental
Arm Description
Extracorporeal shock wave therapy
Arm Title
Second group (conventional rehabilitation)
Arm Type
Active Comparator
Arm Description
conventional rehabilitation
Intervention Type
Device
Intervention Name(s)
Extracorporeal shock wave therapy
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Conventional rehabilitation
Intervention Description
physical & occupational therapy
Primary Outcome Measure Information:
Title
Modified Ashworth Scale
Description
is a valid scoring system for spasticity
Time Frame
Change from Pre to Post 1 [after 3rd session (after 2 weeks from baseline) ] and Post 2 (3 months follow-up)
Title
Fugl-Meyer Assessment
Description
reliable assessment tool for sensorimotor function of the upper extremity of stroke patients
Time Frame
Change from Pre to Post 1 [after 3rd session (after 2 weeks from baseline) ] and Post 2 (3 months follow-up)
Title
Motricity Index
Description
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
Time Frame
Change from Pre to Post 1 [after 3rd session (after 2 weeks from baseline) ] and Post 2 (3 months follow-up)
Title
Hmax / Mmax amplitude ratio
Description
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
Time Frame
Change from Pre to Post 1 [after 3rd session (after 2 weeks from baseline) ] and Post 2 (3 months follow-up)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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
Facility Information:
Facility Name
Tanta university hospital
City
Tanta
State/Province
Gharbia
ZIP/Postal Code
31527
Country
Egypt
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Citations:
PubMed Identifier
27149465
Citation
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). 2016 May;95(18):e3544. doi: 10.1097/MD.0000000000003544.
Results Reference
result
Links:
URL
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4863782/
Description
Effect of Radial Shock Wave Therapy on Spasticity of the Upper Limb in Patients With Chronic Stroke
Learn more about this trial
Extracorporeal Shock Wave Therapy on Wrist and Hand Functions in Spastic Chronic Stroke Patients
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