NCT06198101

Brief Summary

Cerebral palsy (CP) is a common neurodevelopmental disorder characterized by motor impairments, including spasticity, muscle tightness, and limited range of motion in the limbs. Myofascial Release Technique (MRT) has shown promise as a non-invasive intervention for addressing musculoskeletal dysfunctions and improving range of motion in various populations. The study will employ a randomized controlled trial design to investigate the effects of myofascial release technique (MRT) with and without a segmental vibrator on upper limb functions in children with spastic cerebral palsy (CP). The study will be conducted at PSRD and Rising Sun Institute Lahore. A sample of children aged 6-12 years with a diagnosis of spastic CP will be recruited and randomly assigned to two groups: MRT with a segmental vibrator, and MRT without a segmental vibrator. The MRT interventions will be provided by trained therapists for a specified duration and frequency over a period of 4 weeks. Spasticity will be measured by the Modified Ashwarth Scale, Upper limb extremity function via Pediatric Upper Extremity Motor Activity Log-Revised (PMAL), and range of motion will be assessed by Goniometer. Data will be analyzed using appropriate statistical tests to determine the effects of the interventions on upper limb functions in children with spastic CP. Ethical considerations will be followed, and informed consent will be obtained from the participant's parents or legal guardians.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
44

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Dec 2023

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2023

Completed
25 days until next milestone

First Submitted

Initial submission to the registry

December 26, 2023

Completed
15 days until next milestone

First Posted

Study publicly available on registry

January 10, 2024

Completed
5 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 15, 2024

Completed
14 days until next milestone

Study Completion

Last participant's last visit for all outcomes

January 29, 2024

Completed
Last Updated

March 5, 2024

Status Verified

March 1, 2024

Enrollment Period

2 months

First QC Date

December 26, 2023

Last Update Submit

March 4, 2024

Conditions

Keywords

CP childMyofascial release techniqueSegmental vibrator

Outcome Measures

Primary Outcomes (3)

  • Modified Ashwarth Scale

    The Modified Ashworth Scale (MAS) is a commonly used clinical assessment tool to evaluate muscle tone and spasticity in individuals with neurological conditions such as spastic cerebral palsy. It is a reliable and valid method for grading muscle resistance during passive movement(18). interrater reliability of AS and MAS varied from moderate to good. ICC scores of AS were between 0.54 and 0.78 and MAS were between 0.61-0.87. Test-retest results of AS and MAS varied from poor to good. ICC values were between 0.31 and 0.82 for AS and between 0.36 and 0.83 for MAS

    6 weeks

  • The Pediatric Upper Extremity Motor Activity Log-Revised (PMAL)

    this tool is a validated assessment tool designed to measure the quality and quantity of upper extremity use in children with neurological conditions, including spastic cerebral palsy(19). The PMAL consists of a structured interview and a 28-item questionnaire that assesses how frequently and how well a child uses their upper limb in various daily activities. The PMAL has demonstrated good reliability (n=0.91) and validity (r= 05) and has been widely used in research and clinical practice to evaluate upper extremity function and monitor progress in rehabilitation interventions. It offers valuable insights into the effectiveness of therapeutic interventions and helps guide treatment planning and goal setting for children with spastic CP

    6 weeks

  • Goniometer

    : A goniometer is a measurement tool commonly used in rehabilitation and physical therapy to assess the range of motion (ROM) of various joints in the body. It consists of a stationary arm and a movable arm with a protractor-like scale, allowing for precise measurement of joint angles. By aligning the stationary arm with the joint's axis and the movable arm with the body segment, the goniometer provides objective measurements of joint flexibility, mobility, and muscle strength. The goniometer provides valuable quantitative data that can guide treatment planning, monitor patient progress, and assess functional outcomes related to joint movement and mobility

    6 weeks

Study Arms (2)

myofascial release technique

ACTIVE COMPARATOR

This group receive Myofascial Release Technique

Other: Myofascial Release Technique

Myofascial Release Technique along with segmental massage vibrator

EXPERIMENTAL

this group receive Myofascial Release Technique along with segmental massage vibrator

Other: Myofascial Release Technique along with segmental vibrator

Interventions

The treatment will be applied by the therapist standing at the side of the patient with different levels according to subject's tolerance for duration of 3 minutes in each sitting. Level one will be performed by longitudinal movements without causing any tension to the tissues. The level two will be performed by longitudinal movements with light pressure to the tensed muscle. The level three will be performed by compressing the treatment area then passively fullest possible range of motion will be performed and then longitudinal movement will be done with same compression. In level four, the patient will actively move the tissue through the fullest possible range of motion. The taut band will palpate and then firm pressure will be maintained and then longitudinal movements will be performed. Treatment will be applied for two intervention sessions per week and a total of 12 sessions over 6 weeks.

myofascial release technique

this group will receive vibratory stimulations through segmental vibrator along the muscle fibers of upper limb flexors, extensors, and wrist flexors for 10-minutes each session with low amplitude (0.3-0.5 mm peak to peak) at fixed frequency of 150 Hz(23). Along with segmental vibrator group B will also receive myofascial release technique through the same method to the upper limb flexors, extensors, and wrist flexors. Group B will receive both treatments for two intervention sessions per week and a total of 12 sessions over 6 weeks.

Myofascial Release Technique along with segmental massage vibrator

Eligibility Criteria

Age6 Years - 12 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Children aged 6-12 years.
  • Both Boys and Girls
  • Spasticity above 1+ grade of ashworth scale
  • Ability to follow instructions and participate in therapy sessions

You may not qualify if:

  • Unable to follow command.
  • Multiple Musculoskeletal deformities or contractures that may limit upper limb function.
  • Children who are Contraindicated to myofascial release technique or the use of a segmental vibrator for example burn.
  • Recent upper limb surgery or significant upper limb injuries.
  • Participation in any other concurrent therapy or intervention for upper limb function.
  • Inability to commit to the study protocol or attend scheduled therapy sessions

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Riphah International University

Lahore, Punjab Province, 54000, Pakistan

Location

Related Publications (1)

  • Shah JP, Thaker N, Heimur J, Aredo JV, Sikdar S, Gerber L. Myofascial Trigger Points Then and Now: A Historical and Scientific Perspective. PM R. 2015 Jul;7(7):746-761. doi: 10.1016/j.pmrj.2015.01.024. Epub 2015 Feb 24.

    PMID: 25724849BACKGROUND

MeSH Terms

Conditions

Cerebral Palsy

Interventions

Myofascial Release Therapy

Condition Hierarchy (Ancestors)

Brain Damage, ChronicBrain DiseasesCentral Nervous System DiseasesNervous System Diseases

Intervention Hierarchy (Ancestors)

MassageTherapy, Soft TissueMusculoskeletal ManipulationsComplementary TherapiesTherapeuticsPhysical Therapy ModalitiesRehabilitation

Study Officials

  • Maryam Mangrio, MS*

    Riphah International University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Masking Details
Participants will get separate treatment protocols and possible efforts will be put to mask the both group about the treatment.
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: It will be Randomized control trial in which non probabilty convenient sampling will be used. Two groups of 6-12 age will be formed in which participants will be randomly divided. Group A will only receive Myofascial release technique and group B will receive Myofascial release technique with segmental massage vibrator
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 26, 2023

First Posted

January 10, 2024

Study Start

December 1, 2023

Primary Completion

January 15, 2024

Study Completion

January 29, 2024

Last Updated

March 5, 2024

Record last verified: 2024-03

Data Sharing

IPD Sharing
Will not share

Locations