Cerebral PalsyNCT06198140
Effects of Myofascial Release in Cerebral Palsy Children
A study testing myofascial release and quick icing and myofascial release in people with Cerebral Palsy, run by Riphah International University at 1 site in Pakistan.
Trial 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… Read more about this study
- Who is it for?
- Ages 6 to 12 years
- Conditions the study is for
- Cerebral Palsy
- What is being tested?
- myofascial release and quick icing and myofascial release
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 28 participants
- Where
- 1 sitePakistan
- Study dates
- 1 Dec 2023to 5 Feb 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 12 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Subjects with hemiplegic cerebral palsy
- Both genders
- Age between 6 to 12 years
- GMFCS Level I and II
- Modified Ashworth scale (grade1 - grade 3
Who cannot join
- Hypersensitive to cold
- Underwent any corrective surgery
- Specific perceptual and cognitive impairments
- Subjects who has received Botulinium toxin injection in the past 6 months
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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).
- Conditions
- Cerebral Palsy
- Being tested
- myofascial release and quick icing, myofascial release
- Keywords
- Cerebral palsy, Myofascial Release, Range of motion, Quick icing
- Medical subject headings
- Cerebral Palsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
myofascial release and quick icingOther
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 releaseOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Myofascial Release and Quick icing | Experimental | Experimental group will receive myofascial release \& quick icing. Receives: Other: myofascial release and quick icing |
| Myofascial Release | Active comparator | In control group the individuals will receive only myofascial release on ankle planterflexors. Receives: Other: myofascial release |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 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
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jan 2024
- Study start1 Dec 2023
- Primary completion5 Feb 2024
- Study completion5 Feb 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Cerebral PalsyStudies of the same condition, open and under way.
- More trials run by Riphah International UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- Riphah International University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Minal Fatima, MS*, Principal investigator, Riphah International University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06198140
- Sponsor's protocol ID
- REC/RCR&AHS/23/0750
- Status last verified
- Jun 2024
- First submitted
- 26 Dec 2023
- Last updated
- 13 Jun 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 22560759
Study at a glance
From the registry record, last updated by the sponsor on 13 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Myofascial Release With and Without Quick Icing on Tone, Range of Motion and Balance in Children With Cerebral Palsy
- ClinicalTrials.gov ID
- NCT06198140
- Acronym / sponsor ID
- REC/RCR&AHS/23/0750
- Conditions
- Cerebral Palsy
- Keywords
- Cerebral palsy, Myofascial Release, Range of motion, Quick icing
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 28 participants (actual)
- Lead sponsor
- Riphah International UniversityUniversity, hospital or other
- Study start
- 1 Dec 2023 (actual)
- Primary completion
- 5 Feb 2024 (actual)
- Study completion
- 5 Feb 2024 (actual)
- First posted
- 10 Jan 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Myofascial Release and Quick icing | Experimental | Other: myofascial release and quick icingExperimental group will receive myofascial release \& quick icing. |
| Myofascial Release | Active comparator | Other: myofascial releaseIn control group the individuals will receive only myofascial release on ankle planterflexors. |
Who may qualify
- Ages
- 6 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- Subjects with hemiplegic cerebral palsy
- Both genders
- Age between 6 to 12 years
- GMFCS Level I and II
- Modified Ashworth scale (grade1 - grade 3
Key exclusion criteria (4 listed)
- Hypersensitive to cold
- Underwent any corrective surgery
- Specific perceptual and cognitive impairments
- Subjects who has received Botulinium toxin injection in the past 6 months
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| myofascial release and quick icingIn 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. | Other | Myofascial Release and Quick icing |
| myofascial releaseIn 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. | Other | Myofascial Release |
Primary outcome
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
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
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jun 2024.
- Background: PubMed 22560759Whisler 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Minal Fatima, MS* principal investigator
Riphah International University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing myofascial release and quick icing and myofascial release in people with Cerebral Palsy, run by Riphah International University at 1 site in Pakistan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Modified Ashworth Scale (time frame: 4 weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06198140, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jun 2024.