Effects of Myofascial Release in Cerebral Palsy Children

June 11, 2024 updated by: Riphah International University

Effects of Myofascial Release With and Without Quick Icing on Tone, Range of Motion and Balance in Children With Cerebral Palsy

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

This study will be a randomized controlled trial. Study will be approved by ethical committee. After that informed consent will be taken and patients will be included in the study on the basis of inclusion criteria. Non probability convenience sampling technique will be used and study will be conducted on 28 patients with spastic hemiplegic cerebral palsy, 6 to 12 years of age. Patient will be randomly categorize into two groups by using flip coin. Experimental group will receive myofascial release on ankle planterflexors and quick icing treatment protocol on ankle dorsiflexors. Control group will receive only myofascial release treatment protocol on ankle planterflexors. Pre and Post intervention assessment will be made for both groups. Tone of planterflexors will be assessed by Modified Ashworth Scale, ankle passive range of motion will be assessed by goniometer and static balance will be assessed by Romberg test(open eyes).

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
28

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • Pakistan
      • Lahore, Pakistan
        • Riphah International University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Myofascial Release and Quick icing
Experimental group will receive myofascial release & quick icing.
Other: myofascial release and quick icing
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.
Active Comparator: Myofascial Release
In control group the individuals will receive only myofascial release on ankle planterflexors.
Other: myofascial release
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Modified Ashworth Scale
Time Frame: 4 weeks
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)
Time Frame: 4 weeks
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
Time Frame: 4 weeks
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Riphah International University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Minal Fatima, MS*, Riphah International University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
December 1, 2023

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
February 5, 2024

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
February 5, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 26, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 26, 2023

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 10, 2024

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 13, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 11, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • REC/RCR&AHS/23/0750

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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