NCT06198140

Brief Summary

Cerebral palsy (CP) is a common disorder which leads to physical disability in children throughout life and begins in early childhood. In cerebral palsy spasticity is considered as a primary factor leads to much impairment which is inversely related to functional development that means greater the spasticity lowers the level of function. There are many ways to treat spasticity which involve stretching, strengthening, postural education, neuromuscular electrical stimulation, cryotherapy and myofascial release technique.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
28

participants targeted

Target at below P25 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

Click on a node to explore related trials.

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
26 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 5, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 5, 2024

Completed
Last Updated

June 13, 2024

Status Verified

June 1, 2024

Enrollment Period

2 months

First QC Date

December 26, 2023

Last Update Submit

June 11, 2024

Conditions

Keywords

Cerebral palsyMyofascial ReleaseRange of motionQuick icing

Outcome Measures

Primary Outcomes (3)

  • Modified Ashworth Scale

    Modified Ashworth Scale is a subjective 5-point scale. The modified Ashworth scale is the most universally accepted clinical tool used to measure the increase of muscle tone. The modified Ashworth scale is a muscle tone assessment scale used to assess the resistance experienced during passive range of motion, which does not require any instrumentation and is quick to perform. The MAS is the gold standard for the measurement of new assessment tools and has shown to have good intrarater reliability (0.84) and good interrater reliability(0.83).Modified Ashworth Scale is used as a qualitative scale in this study

    4 weeks

  • Romberg test (open eyes)

    The Romberg test is a simple bedside test that should be performed on all patients presenting with imbalance. In the Romberg test with eyes open, the patient is asked to remove shoes and stand with both feet together. Next, the examiner instructs the patient to hold their arms next to the body or crossed in front of the body. The test involves asking the patient to keep their eyes open while the examiner assesses the patient's body movement relative to balance. Romberg sign is positive if the patient is often unsteady with the eyes open

    4 weeks

  • Goniometer

    Goniometer is implemented as quantifiable monitoring device(9). For both upper and lower limb. It is the most extended tool for measuring ROM in the clinical practice. Goniometry is quantifiable monitoring device. Intertester and intratester believability towards goniometric measures at ankle joint are 0.86 and 0.90 in terms of ICC

    4 weeks

Study Arms (2)

Myofascial Release and Quick icing

EXPERIMENTAL

Experimental group will receive myofascial release \& quick icing.

Other: myofascial release and quick icing

Myofascial Release

ACTIVE COMPARATOR

In control group the individuals will receive only myofascial release on ankle planterflexors.

Other: myofascial release

Interventions

In experimental group the individuals will receive myofascial release and quick icing. Quick icing will be on ankle dorsiflexors by using ice pack in the target area. Quick icing will be applied for 10 minutes (time of application 10 seconds and a rest for 20 seconds). This treatment protocol will be 6 times/week for 4 weeks in the hospital setting. Mayofascial release will be given on the target ankle planterflexors. The subjects who will receive Myofascial Release will be positioned in prone with the treatment area exposed. The treatment will be applied by the therapist standing at the side of the patient. Then technique will be applied with different levels by following longitudinal movements according to subject's tolerance for duration of 3 minutes in each sitting. Patients will be given a rest time after each level in order to allow the tissue to soften. This treatment protocol will be 6 times/week for 4 weeks in the hospital setting.

Myofascial Release and Quick icing

In control group the individuals will receive only myofascial release on ankle planterflexors. The subjects who will receive Myofascial Release will be positioned in prone with the treatment area exposed. The treatment will be applied by the therapist standing at the side of the patient. Then technique will be applied with different levels by following longitudinal movements according to subject's tolerance for duration of 3 minutes in each sitting. Patients will be given a rest time after each level in order to allow the tissue to soften. This treatment protocol will be 6 times/week for 4 weeks in the hospital setting.

Myofascial Release

Eligibility Criteria

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

You may qualify if:

  • Subjects with hemiplegic cerebral palsy
  • Both genders
  • Age between 6 to 12 years
  • GMFCS Level I and II
  • Modified Ashworth scale (grade1 - grade 3

You may not qualify if:

  • Hypersensitive to cold
  • Underwent any corrective surgery
  • Specific perceptual and cognitive impairments
  • Subjects who has received Botulinium toxin injection in the past 6 months

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Riphah international university

Lahore, Pakistan

Location

Related Publications (1)

  • Whisler SL, Lang DM, Armstrong M, Vickers J, Qualls C, Feldman JS. Effects of myofascial release and other advanced myofascial therapies on children with cerebral palsy: six case reports. Explore (NY). 2012 May-Jun;8(3):199-205. doi: 10.1016/j.explore.2012.02.003. No abstract available.

    PMID: 22560759BACKGROUND

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

  • Minal Fatima, MS*

    Riphah International University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
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

February 5, 2024

Study Completion

February 5, 2024

Last Updated

June 13, 2024

Record last verified: 2024-06

Data Sharing

IPD Sharing
Will not share

Locations