Myofascial Stretch With And Without Functional Massage In Children With Cerebral Palsy
Primary Purpose
Cerebral Palsy, Functional Massage, Myofacial Stretch
Status
Completed
Phase
Not Applicable
Locations
Pakistan
Study Type
Interventional
Intervention
Myofascial stretch
Functional massage along with myofacial stretch
Sponsored by
About this trial
This is an interventional treatment trial for Cerebral Palsy, Functional Massage, Myofacial Stretch
Eligibility Criteria
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
Sites / Locations
- Rising Sun Institute
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
myofascial stretch group
Functional massage along with myofascial stretch group
Arm Description
Patients will be given myofascial stretch
patients will be given functional massage along with myofascial stretching
Outcomes
Primary Outcome Measures
Change in scores of Modified Ashworth scale
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)
Change in scores of GMFM 88
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)
Secondary Outcome Measures
Full Information
NCT ID
NCT05392335
First Posted
May 23, 2022
Last Updated
March 15, 2023
Sponsor
Riphah International University
1. Study Identification
Unique Protocol Identification Number
NCT05392335
Brief Title
Myofascial Stretch With And Without Functional Massage In Children With Cerebral Palsy
Official Title
Effects Of Myofascial Stretch With And Without Functional Massage On Spasticity And Gross Motor Function In Children With Cerebral Palsy
Study Type
Interventional
2. Study Status
Record Verification Date
March 2023
Overall Recruitment Status
Completed
Study Start Date
May 13, 2022 (Actual)
Primary Completion Date
January 16, 2023 (Actual)
Study Completion Date
January 20, 2023 (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
Yes
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cerebral Palsy, Functional Massage, Myofacial Stretch
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
22 (Actual)
8. Arms, Groups, and Interventions
Arm Title
myofascial stretch group
Arm Type
Active Comparator
Arm Description
Patients will be given myofascial stretch
Arm Title
Functional massage along with myofascial stretch group
Arm Type
Experimental
Arm Description
patients will be given functional massage along with myofascial stretching
Intervention Type
Other
Intervention Name(s)
Myofascial stretch
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Functional massage along with myofacial stretch
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change in scores of Modified Ashworth scale
Description
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)
Time Frame
Baseline and 8th week
Title
Change in scores of GMFM 88
Description
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)
Time Frame
Baseline and 8th 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 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Fareeha Kausar, PP-DPT
Organizational Affiliation
Riphah International University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Rising Sun Institute
City
Lahore
State/Province
Punjab
ZIP/Postal Code
64000
Country
Pakistan
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
31488980
Citation
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.
Results Reference
background
Citation
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.
Results Reference
background
Citation
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.
Results Reference
background
Citation
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.
Results Reference
background
Learn more about this trial
Myofascial Stretch With And Without Functional Massage In Children With Cerebral Palsy
We'll reach out to this number within 24 hrs