- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05251025
Myofascial Release and Sustained Stretching in Spastic CP Children
Comparative Effects of Myofascial Release and Sustained Stretching on Hamstring Flexibility in Spastic Cerebral Palsy Children
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Punjab
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Sahiwal, Punjab, Pakistan, 57000
- District Head Quarter Hospital
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Passive sustained stretching
Passive sustained stretching along with conventional treatments
|
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. |
|
Experimental: Myofascial Release
Myofascial Release Technique along with conventional treatments
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Modified Ashworth Scale (MAS)
Time Frame: 6th week
|
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
Time Frame: 6th week
|
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
Time Frame: 6th week
|
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
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Sara Aabroo, PPDPT, Riphah International University
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- REC/Lhr/21/0220 Iqra Khalid
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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