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Myofascial Release and Sustained Stretching in Spastic CP Children

Primary Purpose

Cerebral Palsy

Status
Completed
Phase
Not Applicable
Locations
Pakistan
Study Type
Interventional
Intervention
Passive sustained stretching
Myofascial Release
Sponsored by
Riphah International University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cerebral Palsy focused on measuring Spastic cerebral palsy, Passive Sustained Stretching, Myofascial Release, MAS, Goniometer

Eligibility Criteria

6 Years - 12 Years (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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.

Sites / Locations

  • District Head Quarter Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Passive sustained stretching

Myofascial Release

Arm Description

Passive sustained stretching along with conventional treatments

Myofascial Release Technique along with conventional treatments

Outcomes

Primary Outcome Measures

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).
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
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.

Secondary Outcome Measures

Full Information

First Posted
February 20, 2022
Last Updated
February 20, 2022
Sponsor
Riphah International University
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1. Study Identification

Unique Protocol Identification Number
NCT05251025
Brief Title
Myofascial Release and Sustained Stretching in Spastic CP Children
Official Title
Comparative Effects of Myofascial Release and Sustained Stretching on Hamstring Flexibility in Spastic Cerebral Palsy Children
Study Type
Interventional

2. Study Status

Record Verification Date
February 2022
Overall Recruitment Status
Completed
Study Start Date
July 15, 2021 (Actual)
Primary Completion Date
September 15, 2021 (Actual)
Study Completion Date
December 15, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Riphah International University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.
Detailed Description
Randomized Clinical Trials done at DHQ Sahiwal. 26 spastic CP children of age 6-12 years were taken by random sampling technique from DHQ Sahiwal. 13 were allocated to each group. Study duration was of 6 months. Sampling technique applied was non probability convenience sampling technique Group A received Passive Sustained Stretching along with conventional treatment. Whereas Group B received MFR along with conventional treatment. Both these groups received treatment for 6 weeks. The baseline and post treatment score of MAS, Goniometer (AKET to measure popliteal angle) and GMFCS -88 were evaluated. Data analysis was done by using the SPSS version 21.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cerebral Palsy
Keywords
Spastic cerebral palsy, Passive Sustained Stretching, Myofascial Release, MAS, Goniometer

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
26 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Passive sustained stretching
Arm Type
Experimental
Arm Description
Passive sustained stretching along with conventional treatments
Arm Title
Myofascial Release
Arm Type
Experimental
Arm Description
Myofascial Release Technique along with conventional treatments
Intervention Type
Other
Intervention Name(s)
Passive sustained stretching
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Myofascial Release
Intervention Description
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.
Primary Outcome Measure Information:
Title
Modified Ashworth Scale (MAS)
Description
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).
Time Frame
6th week
Title
Gross Motor Function Classification System
Description
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
Time Frame
6th week
Title
Active Knee Extension Test
Description
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.
Time Frame
6th week

10. Eligibility

Sex
All
Minimum Age & Unit of Time
6 Years
Maximum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sara Aabroo, PPDPT
Organizational Affiliation
Riphah International University
Official's Role
Principal Investigator
Facility Information:
Facility Name
District Head Quarter Hospital
City
Sahiwal
State/Province
Punjab
ZIP/Postal Code
57000
Country
Pakistan

12. IPD Sharing Statement

Plan to Share IPD
No

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Myofascial Release and Sustained Stretching in Spastic CP Children

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