NCT06292507

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
22

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Dec 2023

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2023

Completed
25 days until next milestone

First Submitted

Initial submission to the registry

December 26, 2023

Completed
2 months until next milestone

First Posted

Study publicly available on registry

March 5, 2024

Completed
11 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 16, 2024

Completed
9 days until next milestone

Study Completion

Last participant's last visit for all outcomes

March 25, 2024

Completed
Last Updated

June 13, 2024

Status Verified

June 1, 2024

Enrollment Period

4 months

First QC Date

December 26, 2023

Last Update Submit

June 11, 2024

Conditions

Cerebral Palsy

Keywords

Myofascial stretchContract-RelaxUpper Limb

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (2)

EFFECTS OF MYOFASCIAL STRETCH

EXPERIMENTAL

This group will receive Myofascial stretch Group.

Other: MYOFASCIAL STRETCH

CONTRACT-RELAX TECHNIQUE ON TONE

EXPERIMENTAL

This group will receive Contract-Relax technique Group

Other: CONTRACT-RELAX TECHNIQUE

Interventions

MYOFASCIAL STRETCHOTHER

Group A 10 participants will receive Myofascial Stretching

EFFECTS OF MYOFASCIAL STRETCH
CONTRACT-RELAX TECHNIQUEOTHER

group B 10 participants will receive Control-Relax Stretching Technique.

CONTRACT-RELAX TECHNIQUE ON TONE

Eligibility Criteria

Age6 Years - 12 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mirza Muhammad Farooq

Dhok Gujra, Punjab Province, 50700, Pakistan

Location

Related 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.

    PMID: 23238223BACKGROUND

MeSH Terms

Conditions

Cerebral Palsy

Condition Hierarchy (Ancestors)

Brain Damage, ChronicBrain DiseasesCentral Nervous System DiseasesNervous System Diseases

Study Officials

  • Mirza Muhammad Farooq, MS*

    Riphah International University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 26, 2023

First Posted

March 5, 2024

Study Start

December 1, 2023

Primary Completion

March 16, 2024

Study Completion

March 25, 2024

Last Updated

June 13, 2024

Record last verified: 2024-06

Data Sharing

IPD Sharing
Will not share

Locations

PA(1)