Home » Trials » SLCTR/2020/004
Effect of Supervised Hand Muscle Strengthening Exercise Program on Grip Strength in Cerebral Palsy Patients at NISANSALA Special Training Center Ja-ela
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SLCTR Registration Number
SLCTR/2020/004
Date of Registration
The date of last modification
Sep 09, 2020
Scientific Title of Trial
Effect of Supervised Hand Muscle Strengthening Exercise Program on Grip Strength in Cerebral Palsy Patients at NISANSALA Special Training Center Ja-ela
Public Title of Trial
Effect of Supervised Hand Muscle Strengthening Exercise Program on Grip Strength in Cerebral Palsy Patients at NISANSALA Special Training Center Ja-ela.
Disease or Health Condition(s) Studied
Cerebral Palsy
Scientific Acronym
None
Public Acronym
None
Brief title
None
Universal Trial Number
U1111-12437706
Any other number(s) assigned to the trial and issuing authority
EC-19-108
What is the research question being addressed?
Does a supervised exercise program have an effect on grip strength in cerebral palsy patients?
Type of study
Interventional
Study design
Allocation
Randomized controlled trial
Masking
Masking not used
Control
Standard therapy/practice
Assignment
Parallel
Purpose
Supportive care
Study Phase
Not Applicable
Intervention(s) planned
Participants in the test group will undergo an individually supervised grip strength exercise program.sessions lasting 15-20 minutes. This will take place twice a week for a total of 8 weeks. The primary investigator will be delivering the intervention. The control will not have any exercise program but will receive standard physiotherapy treatments and ergonomic advice. The intervention group will also receive standard physiotherapy treatment and ergonomic advice
Inclusion criteria
1.Female and male patients aged 12-22 years
Able to communicate clearly and understand the procedure of doing the pre-test, exercise routine and post test
Patient with a diagnosis of cerebral palsy including hemiplegic patients
Those able to provide informed written consent
Exclusion criteria
•Patients who do not have the ability to communicate • Cerebral palsy patients with diplegia and quadriplegia
Primary outcome(s)
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1.
The mean difference in grip strength using a digital handgrip dynamometer |
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Secondary outcome(s)
|
1.
None |
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Target number/sample size
40 individuals ( 20 in each arm)
Countries of recruitment
Sri Lanka
Anticipated start date
2020-02-10
Anticipated end date
2020-04-10
Date of first enrollment
Date of study completion
Recruitment status
Pending
Funding source
Self funded
Regulatory approvals
Approved
Status
Approved
Date of Approval
2019-10-17
Approval number
protocol EC-19-108
Details of Ethics Review Committee
| Name: | Ethics Review Committee of the Faculty of Medicine, University of Colombo. |
| Institutional Address: | PO Box 271, Kynsey road, Colombo 8, Sri Lanka |
| Telephone: | +94-112695300 ext 240 |
| Email: | ethicscommitteemfc@gmail.com |
Contact person for Scientific Queries/Principal Investigator
Siththi Fathima Ilma Osman Sedar
Physiotherapist
NISANSALA Special Training Center Jaela
+94-11-2237360
+94-777-061854
none
ilmasedar@yahoo.com
none
Contact Person for Public Queries
Dr. Chathuranga Ranasinghe
Senior lecturer, Department of Allied Health Sciences
Faculty of Medicine, University of Colombo, Sri Lanka
+94 112 688686
+ 94 773707016
Chath_r@yahoo.com.au
none
Do the investigators plan to share identified individual clinical trial participant-level data (IPD)?
Yes
IPD sharing plan description
individual participant data will be available after de-identification. other documents available: the study protocol,statistical analysis plan ,informed consent form,clinical study report the data will be available immediately following the publication,no end date anyone who wishes to access the data would be able to obtain it the types of analysis is done to achieve the aims in the approved proposal
Study protocol available
Yes
Protocol version and date
Version 1.2, Date- 17.10.2019
Protocol URL
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
