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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT06292507
Other study ID # REC/RCR&AHS/23/0734
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date December 1, 2023
Est. completion date March 25, 2024

Study information

Verified date June 2024
Source Riphah International University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Cerebral palsy (CP) is primarily a neuromotor disorder that affects the development of movement, muscle tone and posture.It is one of the three most common lifelong developmental disabilities, the other two being autism and mental retardation causing considerable hardship to affected individuals and their families. CP is a common problem, the worldwide incidence being 2 to 2.5 per 1000 live births. Myofascial therapy is definable by "the facilitation of mechanical, neural and psycho physiological adaptive potential as interfaced by the myofascial system". The PNF contract-relax technique consists of stretching the target muscle, keeping it in position while the patient isometrically contracts it and relaxes in sequence, producing effects such as maintenance and gain in joint mobility, increased muscle strength, and better motor control whereas The modified Ashworth scale is the most universally accepted clinical tool used to measure the increase of muscle tone This study will be randomized clinical trial and will be conducted in Rasool medical centre Gujrat and City hospital Gujrat. This study will be completed within duration of 6 months after the approval of synopsis.Convenience sampling technique will be used to collect the data. A sample size of total 20 patientswill be taken in the study. 20participants will be equally divided into two group's myofascial stretch and contract-relax stretching techniques having 10participants in each group. Informed consent will be sought from them and they will be clearly explained about the purpose of study.Myofascial Stretching will be applied to Group A and Contract-Relax stretching will be applied to Group B. Results will be analyzed on SPSS.


Description:

Cerebral palsy (CP) is primarily a neuromotor disorder that affects the development of movement, muscle tone and posture. The underlying pathophysiology is an injury to the developing brain in the prenatal through neonatal period. Although the initial neuropathologic lesion is non-progressive, children with CP may develop a range of secondary conditions over time that will variably affect their functional abilities. Cerebral palsy refers to set of lifelong mobility issues and postural defects which restrict function caused by non-progressive abnormalities in growing foetus or neonatal brain. CP is frequently followed by sensory, cognitive, behavioural impairment and musculoskeletal difficulties. CP could categorised as spastic, athetoid, ataxic, or mixed, also classed as hemiplegia, diplegia, quadriplegia, depending on kind of mobility dysfunction. Spasticity of numerous muscle groups is common in CP due to CNS injury


Recruitment information / eligibility

Status Completed
Enrollment 22
Est. completion date March 25, 2024
Est. primary completion date March 16, 2024
Accepts healthy volunteers No
Gender All
Age group 6 Years to 12 Years
Eligibility Inclusion Criteria: - Age between 6 and 12 year(20). - Spastic CP child will be including. - Communication statusand oriented. - Informed written consent of the children's parents was required. Exclusion Criteria: - Orthopedic surgery on upper limb(1). - Received botulinum toxin injection in the upper limb during the last 6 months or who wish to receive it within the period of study(2). - Upper Extremities deformities - Upper limb Contracture Formation

Study Design


Related Conditions & MeSH terms


Intervention

Other:
MYOFASCIAL STRETCH
Group A 10 participants will receive Myofascial Stretching
CONTRACT-RELAX TECHNIQUE
group B 10 participants will receive Control-Relax Stretching Technique.

Locations

Country Name City State
Pakistan Mirza Muhammad Farooq Gujrat Punjab

Sponsors (1)

Lead Sponsor Collaborator
Riphah International University

Country where clinical trial is conducted

Pakistan, 

References & Publications (1)

Choudhary A, Gulati S, Kabra M, Singh UP, Sankhyan N, Pandey RM, Kalra V. Efficacy of modified constraint induced movement therapy in improving upper limb function in children with hemiplegic cerebral palsy: a randomized controlled trial. Brain Dev. 2013 Oct;35(9):870-6. doi: 10.1016/j.braindev.2012.11.001. Epub 2012 Dec 11. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Manual Ability Classification system Psychometric properties of the MACS have been assessed with analysis of content, criterion, construct validity, and reliability. The intraclass correlation coefficient between therapists was 0.97 (95% confidence interval 0.96-0.98), and between parents and therapist was 0.96 (0.89-0.98), indicating excellent agreement 4 month
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