NCT07148856

Brief Summary

"This study aims to evaluate the effectiveness of adding Myofascial Release (MFR) technique to a conventional physiotherapy program for children with cerebral palsy after Achilles tendon surgery. The primary goal is to determine whether MFR can improve functional outcomes such as gross motor function and ankle range of motion, compared to physiotherapy alone. The study will be conducted in Gaza, Palestine, with children diagnosed with cerebral palsy who recently underwent Achilles tendon surgery. Participants will be randomly assigned to either conventional physiotherapy or conventional physiotherapy combined with MFR, and outcomes will be assessed before and after an 8-week intervention program."

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Aug 2025

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 20, 2025

Completed
3 days until next milestone

First Submitted

Initial submission to the registry

August 23, 2025

Completed
6 days until next milestone

First Posted

Study publicly available on registry

August 29, 2025

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 30, 2025

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2025

Completed
Last Updated

August 29, 2025

Status Verified

August 1, 2025

Enrollment Period

3 months

First QC Date

August 23, 2025

Last Update Submit

August 28, 2025

Conditions

Keywords

Myofascial Release Physiotherapy Physical Therapy Pediatric Rehabilitation Gross Motor Function Range of Motion Gaza Strip

Outcome Measures

Primary Outcomes (1)

  • Gross Motor Function Measure (GMFM-88)

    Change in gross motor function measured using the GMFM-88 scale. The scale assesses motor function in children with cerebral palsy across five dimensions: lying \& rolling, sitting, crawling \& kneeling, standing, and walking/running/jumping. Higher scores indicate better motor function.

    Baseline and after 8 weeks of intervention

Secondary Outcomes (2)

  • Pediatric Balance Scale (PBS)

    Baseline and after 8 weeks of intervention

  • Ankle Range of Motion (ROM)

    Baseline and after 8 weeks of intervention

Study Arms (2)

Conventional Physiotherapy (CPT)

ACTIVE COMPARATOR

"Participants will receive a standard conventional physiotherapy program following Achilles tendon surgery. The program includes stretching, strengthening, mobility, and functional training exercises designed to enhance recovery and improve lower limb function."

Other: Conventional Physiotherapy

Conventional Physiotherapy + Myofascial Release (CPT + MFR)

EXPERIMENTAL

"Participants will receive the same conventional physiotherapy program as the control group combined with myofascial release technique. The manual therapy will be applied to the lower limb and ankle region to improve fascial mobility, enhance soft tissue flexibility, and increase ankle range of motion."

Other: Conventional PhysiotherapyOther: Myofascial Release Technique

Interventions

A standard physiotherapy program provided after Achilles tendon surgery, including stretching, strengthening, mobility, and functional training exercises

Conventional Physiotherapy (CPT)Conventional Physiotherapy + Myofascial Release (CPT + MFR)

A manual therapy technique applied to the lower limb and ankle region, aiming to release fascial restrictions, improve soft tissue flexibility, and enhance ankle range of motion.

Conventional Physiotherapy + Myofascial Release (CPT + MFR)

Eligibility Criteria

Age2 Years - 5 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Children aged 2-5 years
  • Spastic cerebral palsy diagnosis (GMFCS levels I-IV).
  • Underwent Achilles tendon surgery within the past 3 months
  • Medically stable and cleared to begin physiotherapy.
  • Parental/guardian consent to participate in the study.

You may not qualify if:

  • Other neuromuscular disorders
  • Severe cognitive impairments that hinder participation
  • Previous MFR therapy within the last 6 months
  • Participation in another rehabilitation study in the past 3 months.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The Jerusalem Princess Basma Centre - Al-Ahli Al-Arabi Hospital, Gaza

Gaza, Gaza Strip, Palestinian Territories

Location

Related Publications (3)

  • Russell DJ, Rosenbaum PL, Avery LM, Lane M. Gross Motor Function Measure (GMFM-66 & GMFM-88) User's Manual. Cambridge University Press; 2002.

    BACKGROUND
  • Barnes MF. The basic science of myofascial release: morphologic change in connective tissue. J Bodyw Mov Ther. 1997;1(4):231-238.

    BACKGROUND
  • Novak I, Morgan C, Fahey M, Finch-Edmondson M, Galea C, Hines A, Langdon K, Namara MM, Paton MC, Popat H, Shore B, Khamis A, Stanton E, Finemore OP, Tricks A, Te Velde A, Dark L, Morton N, Badawi N. State of the Evidence Traffic Lights 2019: Systematic Review of Interventions for Preventing and Treating Children with Cerebral Palsy. Curr Neurol Neurosci Rep. 2020 Feb 21;20(2):3. doi: 10.1007/s11910-020-1022-z.

    PMID: 32086598BACKGROUND

Related Links

MeSH Terms

Interventions

Myofascial Release Therapy

Intervention Hierarchy (Ancestors)

MassageTherapy, Soft TissueMusculoskeletal ManipulationsComplementary TherapiesTherapeuticsPhysical Therapy ModalitiesRehabilitation

Study Officials

  • Ismail K Al Qedra, MSc (Physiotherapy)

    Al-Azhar University - Gaza

    PRINCIPAL INVESTIGATOR
  • Musab M Al Dabbas, PhD

    Al-Azhar University - Gaza

    STUDY DIRECTOR

Central Study Contacts

Ismail K Al Qedra, MSc (Physiotherapy)

CONTACT

Musab M Al Dabbas, phd

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Masking Details
"This is an open-label study; no masking of participants, care providers, investigators, or outcome assessors is implemented."
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: "Participants will be randomly assigned to one of two parallel groups: conventional physiotherapy only or conventional physiotherapy plus myofascial release."
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
MSc Candidate in Orthopedic Physical Therapy

Study Record Dates

First Submitted

August 23, 2025

First Posted

August 29, 2025

Study Start

August 20, 2025

Primary Completion

November 30, 2025

Study Completion

December 31, 2025

Last Updated

August 29, 2025

Record last verified: 2025-08

Data Sharing

IPD Sharing
Will share

De-identified individual participant data (IPD) underlying the results reported in this article will be made available upon reasonable request from the Principal Investigator Ismail Kamal Al Qedra after publication. Data will be shared for academic and research purposes only.

Shared Documents
STUDY PROTOCOL, SAP
Time Frame
IPD and supporting information will be available starting 6 months after publication of the primary results and for a period of 5 years thereafter.
Access Criteria
Access to de-identified IPD and supporting documents will be granted to qualified researchers upon reasonable request. Requests must include a methodologically sound proposal and will be reviewed by the Principal Investigator. Data will be shared via secure electronic transfer.

Locations