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SLCTR Registration Number
SLCTR/2019/040
Date of Registration
The date of last modification
Dec 19, 2019
View original TRDS
Scientific Title of Trial
(APPL/2019/049) The effectiveness of radial Extracorporeal Shock Wave Therapy versus Transcutaneous Electrical Nerve Stimulation in the management of upper limb spasticity in chronic post-stroke hemiplegia: A randomized controlled trial
Public Title of Trial
The effectiveness of radial Extracorporeal Shock Wave Therapy versus Transcutaneous Electrical Nerve Stimulation in the management of upper limb spasticity in chronic post-stroke hemiplegia: A randomized controlled trial
Disease or Health Condition(s) Studied
stroke
Scientific Acronym
rESWT vs TENS
Public Acronym
None
Brief title
rESWT vs TENS for chronic post-stroke upper limb spasticity
Universal Trial Number
U1111-1243-1762
Any other number(s) assigned to the trial and issuing authority
2019/ EC/ 35
What is the research question being addressed?
Is radial extracorporeal shock wave therapy (rESWT) more effective than transcutaneous electrical nerve stimulation (TENS) in treating the upper limb spasticity of patients with chronic post-stroke hemiplegia?
Type of study
Interventional
Study design
Allocation
Randomized controlled trial
Masking
Masking not used
Control
Active
Assignment
Single
Purpose
Treatment
Study Phase
Phase 2
Intervention(s) planned
The study will be conducted at teaching hospital, Peradeniya and at the Department of Physiotherapy, Faculty of Allied Health Sciences, University of Peradeniya..
The control group will receive transcutaneous electrical nerve stimulation (TENS), frequency of 100 Hz over Teres major, Brachialis, Flexor carpi ulnaris and Flexor digitorum profundus muscles, fifteen minutes for each muscle followed by task oriented exercises for upper limb for 30 minutes. The experimental group will receive radial extracorporeal shock wave therapy (rESWT), 1500 shots per muscle, frequency of 5Hz, energy of 0.030 mJ/mm, over Teres major, Brachialis, Flexor carpi ulnaris and Flexor digitorum profundus muscles followed by task oriented exercises for upper limb for 30 minutes. All the patients will receive transcutaneous electrical nerve stimulation or radial extracorporeal shock wave therapy once a week for four weeks continuously according to the group to which he or she was assigned. All the patients will receive the task oriented exercises three times per week for four weeks. All the subjects will be assessed for their voluntary movement grading for the upper limb, spasticity grading for upper limb and their hand function grading immediately after the TENS or rESWT treatment has been given, at the end of the four weeks of treatment and after eight, twelve, sixteen and twenty weeks. After four weeks of the treatment session patients will be asked to follow the task oriented exercises for upper limb at home.
Inclusion criteria
Exclusion criteria
1.Patients with reflex sympathetic dystrophy/ severe shoulder subluxation/ shoulder dislocation/ contracture in the affected UL/ fixed deformity of hand/ shoulder hand syndrome 2.Any neurological disorder or pain that might limits arm movement 3. Patients who have received botox injection or acupuncture within past 6 months to the affected UL 4. Complete sensory loss of upper limb 5. Presence of high risk cardiovascular disorders such as myocardial infarction, heart failure 6. Severe hypertension defined as SBP? 180 and or DBP ? 110 7. Presence of convulsions 8. Patients with visual impairment 9. Patients with behavioral problems 10. Already enrolled in some form of physical therapy
Primary outcome(s)
1.
• Spasticity grading of affected upper limb using Modified Ashwath scale • Voluntary control of affected upper limb according to a grading system |
[ All the subjects will be assessed for spasticity of upper limb and voluntary control of upper limb immediately after the TENS or rESWT treatment has been given, and at the end of the four weeks treatment session eight, twelve, sixteen and twenty weeks after the first treatment ] |
Secondary outcome(s)
1.
• Fugl - Meyer motor assessment of physical performance of upper limb • Action research arm test |
[ All the subjects will be assessed for hand function grading immediately after the TENS or rESWT treatment has been given, at the end of the four weeks treatment session and after eight, twelve, sixteen and twenty weeks after the first treatment ] |
Target number/sample size
108 in total
Countries of recruitment
Sri Lanka
Anticipated start date
2019-12-20
Anticipated end date
2021-12-20
Date of first enrollment
Date of study completion
Recruitment status
Pending
Funding source
None
Regulatory approvals
Status
Approved
Date of Approval
2019-10-17
Approval number
2019/EC/35
Details of Ethics Review Committee
Name: | M.K.I.Dilhari Senarath |
Institutional Address: | Ethics review committee, Faculty of Medicine, University of Peradeniya, Sri Lanka |
Telephone: | 0812396361 |
Email: | chairpersonierc@gmail.com |
Contact person for Scientific Queries/Principal Investigator
M.K.I.Dilhari Senarath
Lecturer (Probationary)
Department of Physiotherapy
Faculty of Allied Health Sciences
University of Peradeniya
0813999623
072379970/ 0713720006
dilsenarath7@gmail.com/ dilharisenarath@ahs.pdn.ac.lk
Contact Person for Public Queries
Dr. L.P.M.M.K. Pathirage,
Senior Lecturer (Consultant Physician),
Department of Medicine,
Faculty of Medicine,
University of Peradeniya.
+94812396470
+94812396470
manojipathi@yahoo.com
Do the investigators plan to share identified individual clinical trial participant-level data (IPD)?
No
IPD sharing plan description
Study protocol available
No
Protocol version and date
Not Available
Protocol URL
Not Available
Results summary available
No
Date of posting results
Date of study completion
Final sample size
Date of first publication
Link to results
Brief summary of results