Cerebral PalsyNCT05251025
Myofascial Release and Sustained Stretching in Spastic CP Children
A study testing Passive sustained stretching and Myofascial Release in people with Cerebral Palsy, run by Riphah International University at 1 site in Pakistan.
Trial 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. Read more about this study
- Who is it for?
- Ages 6 to 12 years
- Conditions the study is for
- Cerebral Palsy
- What is being tested?
- Passive sustained stretching and Myofascial Release
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 26 participants
- Where
- 1 sitePakistan
- Study dates
- 15 Jul 2021to 15 Dec 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 12 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Pakistan1 site
District Head Quarter Hospital
Sahiwal, Punjab Province, 57000
About this study
Official title: Comparative Effects of Myofascial Release and Sustained Stretching on Hamstring Flexibility in Spastic Cerebral Palsy Children
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.
Read the 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.
- Conditions
- Cerebral Palsy
- Being tested
- Passive sustained stretching, Myofascial Release
- Keywords
- Spastic cerebral palsy, Passive Sustained Stretching, Myofascial Release, MAS, Goniometer
- Medical subject headings
- Cerebral Palsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Passive sustained stretchingOther
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.
Myofascial ReleaseOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Passive sustained stretching | Experimental | Passive sustained stretching along with conventional treatments Receives: Other: Passive sustained stretching |
| Myofascial Release | Experimental | Myofascial Release Technique along with conventional treatments Receives: Other: Myofascial Release |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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
Measured: 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.
Measured: 6th week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Feb 2022
- Study start15 Jul 2021
- Primary completion15 Sep 2021
- Study completion15 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cerebral PalsyStudies of the same condition, open and under way.
- More trials run by Riphah International UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 26 participants (actual)
Sponsor and investigators
- Lead sponsor
- Riphah International University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Sara Aabroo, PPDPT, Principal investigator, Riphah International University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05251025
- Sponsor's protocol ID
- REC/Lhr/21/0220 Iqra Khalid
- Status last verified
- Feb 2022
- First submitted
- 20 Feb 2022
- Last updated
- 22 Feb 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Effects of Myofascial Release and Sustained Stretching on Hamstring Flexibility in Spastic Cerebral Palsy Children
- ClinicalTrials.gov ID
- NCT05251025
- Acronym / sponsor ID
- REC/Lhr/21/0220 Iqra Khalid
- Conditions
- Cerebral Palsy
- Keywords
- Spastic cerebral palsy, Passive Sustained Stretching, Myofascial Release, MAS, Goniometer
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 26 participants (actual)
- Lead sponsor
- Riphah International UniversityUniversity, hospital or other
- Study start
- 15 Jul 2021 (actual)
- Primary completion
- 15 Sep 2021 (actual)
- Study completion
- 15 Dec 2021 (actual)
- First posted
- 22 Feb 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Passive sustained stretching | Experimental | Other: Passive sustained stretchingPassive sustained stretching along with conventional treatments |
| Myofascial Release | Experimental | Other: Myofascial ReleaseMyofascial Release Technique along with conventional treatments |
Who may qualify
- Ages
- 6 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Passive sustained stretchingThe 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. | Other | Passive sustained stretching |
| Myofascial ReleaseThe 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. | Other | Myofascial Release |
Primary outcome
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).
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
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Feb 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sara Aabroo, PPDPT principal investigator
Riphah International University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Passive sustained stretching and Myofascial Release in people with Cerebral Palsy, run by Riphah International University at 1 site in Pakistan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Feb 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Modified Ashworth Scale (MAS) (time frame: 6th week). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Feb 2022.