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CompletedNCT06760793Updated Jan 8, 2025

Deep Friction Massage in Children With Spastic Cerebral Palsy

An interventional study of manual static stretching exercises on plantar flexors and deep friction massage on plantar flexors in Spastic Cerebral Palsy (sCP), sponsored by Muğla Sıtkı Koçman University. Completed at 1 site in Turkey (Türkiye). Open to participants aged 3 Years to 18 Years. Per ClinicalTrials.gov, last updated 2025-01-08.

Sponsored by Muğla Sıtkı Koçman University · Not applicable, Interventional, and Supportive care

From the registry’s dates

  • Registered 1 year 10 months after the study started (first participant enrolled Feb 2023, registered Dec 2024).
Phase
Not applicable
Study type
Interventional
Enrollment
46
Allocation
Randomized
Ages
3 Years to 18 Years
Sex
All
01

Study 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 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.

02

Conditions studied

  • Spastic Cerebral Palsy (sCP)

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03

In context

Cerebral Palsy

1,891 studies on the registry are indexed under Cerebral Palsy; 439 are open to participants now.

This study's enrollment of 46 is above the median of 34 across 1,396 interventional studies indexed under Cerebral Palsy.

Browse Cerebral Palsy studies →

Lead sponsor

Muğla Sıtkı Koçman University is the lead sponsor of 114 studies on the registry; 19 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
3 Years to 18 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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.
05

Study design

Phase
Not applicable
Primary purpose
Supportive care
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Outcomes assessor)
Enrollment
46 participants (actual)

Study arms

  • Experimental
    Group 1

    Other: manual static stretching exercises on plantar flexors

  • Experimental
    Group 2

    Other: deep friction massage on plantar flexors

Interventions

  • Othermanual static stretching exercises on plantar flexors

    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

  • Otherdeep friction massage on plantar flexors

    Deep Friction Massage was applied to both the gastrocnemius muscle and the Achilles tendon. Participants were positioned in a prone posture for both applications

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: before intervention and after 6 weeks

Secondary outcomes

  1. 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.

    Time frame: Before intervention and after 6 weeks

  2. 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

    Time frame: Before intervention and after 6 weeks

  3. 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°

    Time frame: Before intervention and after 6 weeks

07

Study locations

1 site
  • Mugla Sitki Kocman University
    Muğla, Menteşe, Turkey (Türkiye)
08

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Feb 2023 to primary completion in May 2024, 14 months.

Of 882 non-industry interventional studies with no phase under Cerebral Palsy, half reached primary completion within 12 months of starting (the median), counting those still running; a quarter within 5 and three quarters within 31. This study's 14 months is above that.

Counting every sponsor, half of 900 studies reached it within 12 months; a quarter within 5 and three quarters within 31.

How these figures are worked out, and which studies are left out of them.

Registered
Dec 30, 2024
First posted
Jan 7, 2025
StartActual
Feb 23, 2023
Primary completionActual
May 1, 2024
CompletionActual
Jun 1, 2024
Last update
Jan 8, 2025
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jan 8, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT06760793
Responsible party
Meltem Koc (Assistant Professor, Muğla Sıtkı Koçman University) — Principal investigator
First posted
Jan 7, 2025
Start date
Feb 23, 2023
Primary completion
May 1, 2024
Completion
Jun 1, 2024
Last update
Jan 8, 2025

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Jan 2025. You cannot join it, but the record below documents what was studied.

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