- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06760793
Deep Friction Massage in Children With Spastic Cerebral Palsy
January 6, 2025 updated by: Meltem Koc, Muğla Sıtkı Koçman University
Comparison of the Effectiveness of Static Stretching and Deep Friction Massage Applied to Plantar Flexors in Children With Spastic Cerebral Palsy
The aim of this clinical trial is to determine whether deep friction massage and stretching reduce muscle contraction in the calf muscle. The primary questions it seeks to answer are:
- Does deep friction massage or stretching reduce muscle contraction?
- Does deep friction massage or stretching improve walking?
- Does deep friction massage or stretching increase ankle joint range of motion?
Participants:
Participants will undergo either deep friction massage or stretching exercises for 10 minutes, three days a week, over a period of six weeks.
Study Overview
Status
Completed
Conditions
Study Type
Interventional
Enrollment (Actual)
46
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
-
-
Menteşe
-
Muğla, Menteşe, Turkey
- Mugla Sitki Kocman University
-
-
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
- Child
- Adult
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- a diagnosis of spastic diplegic or hemiparetic CP
- aged between 3 and 18 years
- classified as level I, II, or III according to the Gross Motor Function Classification System (GMFCS)
- possessing sufficient cognitive function to cooperate.
Exclusion Criteria:
- Botulinum toxin (BoNT) injections to the lower extremity muscles within the last six months
- undergoing any surgery such as muscle lengthening or joint contracture within the last six months
- non-participation in two consecutive exercise sessions
- experiencing illnesses such as infections or musculoskeletal injuries during the study period.
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: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Group 2
|
Deep Friction Massage was applied to both the gastrocnemius muscle and the Achilles tendon.
Participants were positioned in a prone posture for both applications
|
|
Experimental: Group 1
|
A manual static stretching exercises was performed on the plantar flexors in both knee extension and flexion.
The stretch was applied while the participant was in a prone position
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
The Modified Ashworth Scale
Time Frame: before intervention and after 6 weeks
|
The Modified Ashworth Scale (MAS) is the most widely used clinical scale for measuring increases in muscle tone.
The original Ashworth Scale was a 5-point numerical scale that graded spasticity from 0 to 4, with 0 indicating no resistance and 4 indicating a limb that is rigid in flexion or extension.
|
before intervention and after 6 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
The Modified Tardieu Scale
Time Frame: Before intervention and after 6 weeks
|
The Modified Tardieu Scale (MTS) is a clinical tool used to assess spasticity by evaluating the muscle's response to passive stretch at varying velocities.
This scale was a 5-point numerical scale that graded spasticity from 0 to 5, with 0 indicating no resistance and 5 indicating a limb that is rigid in flexion or extension.
|
Before intervention and after 6 weeks
|
|
Range of motion (ROM)
Time Frame: Before intervention and after 6 weeks
|
Range of motion (ROM) of ankle assessments were conducted using a standard goniometer.
In these measurements, the initial position of the ankle was set to a 90° angle between the fibula and the 5th metatarsal.
Participants were positioned in a supine position with a thin pillow placed under their knees.
The pivot point of the goniometer was aligned with the lateral malleolus, while the fixed arm was positioned parallel to the midline of the fibula.
The moving arm of the goniometer followed the midline of the 5th metatarsal.
The participant was then instructed to perform active dorsiflexion and plantar flexion movements, with the results recorded.
This procedure was repeated for passive dorsiflexion and plantar flexion movements
|
Before intervention and after 6 weeks
|
|
The Modified Timed Up and Go Test (TUG)
Time Frame: Before intervention and after 6 weeks
|
The Modified Timed Up and Go Test (TUG) is a simple and objective clinical test that assesses walking speed, postural control, functional level, balance, and locomotor performance.
In this test, the participant is asked to rise from a chair without armrests, walk at their own pace to touch a target placed 3 meters away, return to the starting point, and sit down again.
The time taken to complete this task is recorded in seconds.
The participant's starting position is sitting in a chair with the hip and knee joints flexed at 90°
|
Before intervention and after 6 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
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)
February 23, 2023
Primary Completion (Actual)
May 1, 2024
Study Completion (Actual)
June 1, 2024
Study Registration Dates
First Submitted
December 30, 2024
First Submitted That Met QC Criteria
December 30, 2024
First Posted (Actual)
March 25, 2025
Study Record Updates
Last Update Posted (Actual)
March 25, 2025
Last Update Submitted That Met QC Criteria
January 6, 2025
Last Verified
January 1, 2025
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2023/30
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
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.