NCT05251025

Brief Summary

The aim of this research was to find and compare the effects of Myofascial Release Technique and Passive Sustained Stretching on Hamstrings Flexibility in Children with Spastic Cerebral Palsy.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
26

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jul 2021

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 15, 2021

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 15, 2021

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 15, 2021

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

February 20, 2022

Completed
2 days until next milestone

First Posted

Study publicly available on registry

February 22, 2022

Completed
Last Updated

February 22, 2022

Status Verified

February 1, 2022

Enrollment Period

2 months

First QC Date

February 20, 2022

Last Update Submit

February 20, 2022

Conditions

Keywords

Spastic cerebral palsyPassive Sustained StretchingMyofascial ReleaseMASGoniometer

Outcome Measures

Primary Outcomes (3)

  • Modified Ashworth Scale (MAS)

    Modified Ashworth scale is one of the most internationally accepted clinical tool that is to measure the increased tone in the muscles. Ashworth Scale in 1964 was published by Bryan Ashworth. This clinical tool has been used as a method for grading spasticity, especially in patients with Cerebral Palsy, Multiple sclerosis etc. The reliability of Modified Ashworth Scale is(ICC+=0.686).

    6th week

  • Gross Motor Function Classification System

    The Gross Motor Function Classification System (GMFCS-88) is a five-level system that is basically is considered as a standardized method to explain gross motor function in CP Children. This GMFCS is used in CP Children with age ranging from 1 to 12 years. The basic focus in this tool is the sitting and walking of the CP Children. This classification system can simply be merged into medical practice. This will help to make assessments of the affected children. It also shows major or clear differences in the gross motor functions of Cp children that are impactful in the daily activities. the intra-rater and inter-rater reliability of GMFCS is 0.98 and 0.97 respectively

    6th week

  • Active Knee Extension Test

    For Active Knee Extension Test that helped to measure popliteal angle the patient was asked to lie supine on the examination table with hip and the knee flexed to 90 degrees and the test was done on both legs alternatively. The examiner then supported the testing thigh so that it remained vertical and asked the patient to extend the knee actively while the contralateral leg remained extended. This active knee extension was done voluntarily. After this, the examiner held that knee extension for 5 seconds to support and keep the stretch to find the point of maximum resistance to ensure the exact readings. To measure the readings, the examiner placed a 360 degrees goniometer on the landmarks being marked for taking the readings. The landmarks used as reference for goniometer were greater trochanter of the femur and lateral malleolus of the tibia.

    6th week

Study Arms (2)

Passive sustained stretching

EXPERIMENTAL

Passive sustained stretching along with conventional treatments

Other: Passive sustained stretching

Myofascial Release

EXPERIMENTAL

Myofascial Release Technique along with conventional treatments

Other: Myofascial Release

Interventions

The Group A received Passive Stretching Technique. Along with the Passive Stretching Technique, this group also received certain conventional treatments which included resistive exercises, gait training exercises, bridging and exercises in other functional positions were also undertaken by the included individuals. All the exercises mentioned above were performed for 30 minutes and there was not any specific division of time for all these mentioned activities. The patients used to perform these conventional treatments and exercises on their motor control basis. The exercises were performed for 30 minutes and been done for 5 days in a week for consecutive 6 weeks.

Passive sustained stretching

The Group B received Myofascial Release Technique and along with conventional treatments. The Myofascial Release Technique for hamstrings was given to the patient in prone position. The technique was applied either by the crossed hands or thumbs. This total treatment was given for 30 minutes consecutively. After the technique the Myofascial structures were stretched and then were hold for straight 120 seconds so that the tissues get softened. The technique was given to patients with 6 repetitions and with a hold for 120 seconds. The treatment was continued for 5 days a week for straight 6 weeks.

Myofascial Release

Eligibility Criteria

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

You may qualify if:

  • Age range from 6 to 12 years were included.
  • Both genders were included.
  • Ambulatory subjects with or without ambulatory aids.
  • Diagnosed children with Spastic CP.
  • CP patients with grade 3 on modified Ashworth scale for hamstrings were included

You may not qualify if:

  • Children with visual or auditory defects.
  • Children with cognitive dysfunction.
  • Subjects who had severe limitations in passive range of motion at lower extremities specially hamstrings due to surgery or any other complication.
  • Children with other types of Cerebral Palsy such as Ataxic CP, Dyskinetic CP etc.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

District Head Quarter Hospital

Sahiwal, Punjab Province, 57000, Pakistan

Location

MeSH Terms

Conditions

Cerebral Palsy

Interventions

Myofascial Release Therapy

Condition Hierarchy (Ancestors)

Brain Damage, ChronicBrain DiseasesCentral Nervous System DiseasesNervous System Diseases

Intervention Hierarchy (Ancestors)

MassageTherapy, Soft TissueMusculoskeletal ManipulationsComplementary TherapiesTherapeuticsPhysical Therapy ModalitiesRehabilitation

Study Officials

  • Sara Aabroo, PPDPT

    Riphah International University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 20, 2022

First Posted

February 22, 2022

Study Start

July 15, 2021

Primary Completion

September 15, 2021

Study Completion

December 15, 2021

Last Updated

February 22, 2022

Record last verified: 2022-02

Data Sharing

IPD Sharing
Will not share

Locations