- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05392335
Myofascial Stretch With And Without Functional Massage In Children With Cerebral Palsy
March 15, 2023 updated by: Riphah International University
Effects Of Myofascial Stretch With And Without Functional Massage On Spasticity And Gross Motor Function In Children With Cerebral Palsy
Cerebral palsy is one of the most common childhood disabilities, and it occurs with an incidence of 2-2.5 per 1000 living births.
Children with CP have various impairments including neuromuscular and musculoskeletal problems such as spasticity, dyscoordination, loss of selective motor control, and weakness.
CP can be classified according to the severity of motor deficits as mild, moderate, or severe.
Several other classification systems exist based on the pathophysiology, etiology, and distribution of motor deficits.
The aim of the study to evaluate the effects of functional massage and myofascial stretch on spasticity and motor function of CP Children.
Study will be conducted in 22 patients in experimental and control group.
Pre and Post values will be evaluated.
The tools used will be Modified Ashworth Scale (MAS) and Gross Motor Function Measure (GMFM).
The significance of this study is that it will define for us that to how much extent we can improve the Spastic and painful condition of lower limb of CP child.
Data will be analyzed using SPSS 22.0 mean and standard deviation will be calculated.
Appropriate the statistical test will be used after checking normality of data.
Study Overview
Status
Completed
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
22
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Punjab
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Lahore, Punjab, Pakistan, 64000
- Rising Sun Institute
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
6 years to 12 years (Child)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Age of 6 and 12 year
- Both genders
- Children between level Ⅰ- Ⅳ based on Gross Motor Classification System(GMFCS)
Exclusion Criteria:
- The existence of dyskinesia or dystonia
- History of muscle lengthening surgery
- Presence of uncontrolled seizures
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
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 |
|---|---|
|
Active Comparator: myofascial stretch group
Patients will be given myofascial stretch
|
Myofascial stretch will be applied at hip adductors, hamstrings and calf muscles for 10 -15 repetitions on each muscle.
2-3 sessions will be performed in a week for 8 weeks.
|
|
Experimental: Functional massage along with myofascial stretch group
patients will be given functional massage along with myofascial stretching
|
Myofascial stretch will be applied at hip adductors, hamstrings and calf muscles for 10 -15 repetitions on each muscle.
2-3 sessions will be performed in a week for 8 weeks.
In this group during the first 20 minutes, ten minutes FM will be applied to each lower extremity of the subject.
The muscle groups to which FM would be applied were hip adductors, hamstrings and calf muscles.
During the remaining period traditional physiotherapy involving myofascial strecth will be given.
2-3 session will be performed in a week for 8 weeks.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in scores of Modified Ashworth scale
Time Frame: Baseline and 8th week
|
The modified Ashworth scale(MAS) is a 6-point rating scale that is used to measure muscle tone.(20)
The reliability of the modified Ashworth scale was very good (κw = .84
for inter rater and .83
for intra-rater comparisons)
|
Baseline and 8th week
|
|
Change in scores of GMFM 88
Time Frame: Baseline and 8th week
|
The GMFM is a standardized observational instrument designed and validated to measure change in gross motor function over time in children with cerebral palsy.
The scoring key is meant to be a general guideline.
However, most of the items have specific descriptors for each score.
It is imperative that the guidelines contained in the manual be used for scoring each item.
SCORING KEY 0 = does not initiate 1 = initiates 2 = partially completes 3 = completes 9 (or leave blank) = not tested (NT)
|
Baseline and 8th week
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Mahmood Q, Habibullah S, Babur MN. Potential effects of traditional massage on spasticity and gross motor function in children with spastic cerebral palsy: A randomized controlled trial. Pak J Med Sci. 2019 Sep-Oct;35(5):1210-1215. doi: 10.12669/pjms.35.5.478.
- BİNGÖL H, YILMAZ Ö. Effects of functional massage on spasticity and motor functions in children with cerebral palsy: a randomized controlled study. Journal of Exercise Therapy and Rehabilitation. 2018;5(3):135-42.
- Bingöl H, Akaras E, Kocaman H. The effects of massage therapy on symptoms related cerebral palsy in children with cerebral palsy: A systematic review. Journal of Clinical Medicine of Kazakhstan. 2020;4(58):6-14.
- Kuruma H, Takei H, Nitta O, Furukawa Y, Shida N, Kamio H, et al. Effects of Myofascial Release and Stretching Technique on Range of Motion and Reaction Time. Journal of Physical Therapy Science. 2013;25(2):169-71.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
May 13, 2022
Primary Completion (Actual)
January 16, 2023
Study Completion (Actual)
January 20, 2023
Study Registration Dates
First Submitted
May 23, 2022
First Submitted That Met QC Criteria
May 23, 2022
First Posted (Actual)
May 26, 2022
Study Record Updates
Last Update Posted (Actual)
March 16, 2023
Last Update Submitted That Met QC Criteria
March 15, 2023
Last Verified
March 1, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- REC/RCR & AHS/22/0705
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
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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