Spastic Cerebral Palsy (sCP)NCT06760793
Deep Friction Massage in Children With Spastic Cerebral Palsy
A study testing manual static stretching exercises on plantar flexors and deep friction massage on plantar flexors in people with Spastic Cerebral Palsy (sCP), run by Muğla Sıtkı Koçman University at 1 site in Turkey (Türkiye).
Trial summary
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… Read more about this study
- Who is it for?
- Ages 3 to 18 years
- Conditions the study is for
- Spastic Cerebral Palsy (sCP)
- What is being tested?
- manual static stretching exercises on plantar flexors and deep friction massage on plantar flexors
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 46 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 23 Feb 2023to 1 Jun 2024
- 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 3 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Spastic Cerebral Palsy (sCP)
- Being tested
- manual static stretching exercises on plantar flexors, deep friction massage on plantar flexors
- Medical subject headings
- Cerebral Palsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
manual static stretching exercises on plantar flexorsOther
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
deep friction massage on plantar flexorsOther
Deep Friction Massage was applied to both the gastrocnemius muscle and the Achilles tendon. Participants were positioned in a prone posture for both applications
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Experimental | Not described Receives: Other: manual static stretching exercises on plantar flexors |
| Group 2 | Experimental | Not described Receives: Other: deep friction massage on plantar flexors |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Modified Ashworth Scale
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.
Measured: before intervention and after 6 weeks
Secondary outcomes (3)
The Modified Tardieu Scale
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.
Measured: Before intervention and after 6 weeks
Range of motion (ROM)
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
Measured: Before intervention and after 6 weeks
The Modified Timed Up and Go Test (TUG)
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°
Measured: Before intervention and after 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jan 2025
- Study start23 Feb 2023
- Primary completion1 May 2024
- Study completion1 Jun 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Spastic Cerebral Palsy (sCP)Studies of the same condition, open and under way.
- 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 46 participants (actual)
Sponsor and investigators
- Lead sponsor
- Muğla Sıtkı Koçman University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Meltem Koc, Muğla Sıtkı Koçman University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06760793
- Sponsor's protocol ID
- 2023/30
- Status last verified
- Jan 2025
- First submitted
- 30 Dec 2024
- Last updated
- 8 Jan 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of the Effectiveness of Static Stretching and Deep Friction Massage Applied to Plantar Flexors in Children With Spastic Cerebral Palsy
- ClinicalTrials.gov ID
- NCT06760793
- Acronym / sponsor ID
- 2023/30
- Conditions
- Spastic Cerebral Palsy (sCP)
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 46 participants (actual)
- Lead sponsor
- Muğla Sıtkı Koçman UniversityUniversity, hospital or other
- Study start
- 23 Feb 2023 (actual)
- Primary completion
- 1 May 2024 (actual)
- Study completion
- 1 Jun 2024 (actual)
- First posted
- 7 Jan 2025 (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 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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group 1 | Experimental | Other: manual static stretching exercises on plantar flexors |
| Group 2 | Experimental | Other: deep friction massage on plantar flexors |
Who may qualify
- Ages
- 3 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
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 |
|---|---|---|
| manual static stretching exercises on plantar flexorsA 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 | Other | Group 1 |
| deep friction massage on plantar flexorsDeep Friction Massage was applied to both the gastrocnemius muscle and the Achilles tendon. Participants were positioned in a prone posture for both applications | Other | Group 2 |
Primary outcome
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.
3 secondary outcomes
The Modified Tardieu Scale
Time frame: Before intervention and after 6 weeks
Range of motion (ROM)
Time frame: Before intervention and after 6 weeks
The Modified Timed Up and Go Test (TUG)
Time frame: Before intervention and after 6 weeks
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 8 Jan 2025.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing manual static stretching exercises on plantar flexors and deep friction massage on plantar flexors in people with Spastic Cerebral Palsy (sCP), run by Muğla Sıtkı Koçman University at 1 site in Turkey (Türkiye).
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 4 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 8 Jan 2025. 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 Turkey (Türkiye). 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?
The Modified Ashworth Scale (time frame: before intervention and after 6 weeks). 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 8 Jan 2025.