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

30 Jan 2020

The date of last modification

Jan 31, 2020



Application Summary


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


Trial Details


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

  1. Able to communicate clearly and understand the procedure of doing the pre-test, exercise routine and post test

  2. Patient with a diagnosis of cerebral palsy including hemiplegic patients

  3. 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)

1.

The mean difference in grip strength using a digital handgrip dynamometer

[
  • Pre and 8 weeks post intervention
]

Secondary outcome(s)

1.

None

[]

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



State of Ethics Review Approval


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 & Sponsor Information


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


Primary study sponsor/organization







Secondary study sponsor (If any)







Trial Completion details


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