Cerebral PalsyNCT06292507
Comparative Effects of Myofascial Stretch and Contract-relax in Children With Spastic cp
A study testing MYOFASCIAL STRETCH and CONTRACT-RELAX TECHNIQUE in people with Cerebral Palsy, run by Riphah International University at 1 site in Pakistan.
Trial summary
Cerebral palsy (CP) is primarily a neuromotor disorder that affects the development of movement, muscle tone and posture.It is one of the three most common lifelong developmental disabilities, the other two being autism and mental retardation causing considerable hardship to affected individuals and their families. 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 STRETCH and CONTRACT-RELAX TECHNIQUE
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 22 participants
- Where
- 1 sitePakistan
- Study dates
- 1 Dec 2023to 25 Mar 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
- Age between 6 and 12 year(20).
- Spastic CP child will be including.
- Communication statusand oriented.
- Informed written consent of the children's parents was required.
Who cannot join
- Orthopedic surgery on upper limb(1).
- Received botulinum toxin injection in the upper limb during the last 6 months or who wish to receive it within the period of study(2).
- Upper Extremities deformities
- Upper limb Contracture Formation
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparative Effects of Myofascial Stretch and Contract-relax Technique on Tone and Function of Upper Limb in Children With Spastic Cerebral Palsy
Cerebral palsy (CP) is primarily a neuromotor disorder that affects the development of movement, muscle tone and posture.It is one of the three most common lifelong developmental disabilities, the other two being autism and mental retardation causing considerable hardship to affected individuals and their families. CP is a common problem, the worldwide incidence being 2 to 2.5 per 1000 live births. Myofascial therapy is definable by "the facilitation of mechanical, neural and psycho physiological adaptive potential as interfaced by the myofascial system". The PNF contract-relax technique consists of stretching the target muscle, keeping it in position while the patient isometrically contracts it and relaxes in sequence, producing effects such as maintenance and gain in joint mobility, increased muscle strength, and better motor control whereas The modified Ashworth scale is the most universally accepted clinical tool used to measure the increase of muscle tone This study will be randomized clinical trial and will be conducted in Rasool medical centre Gujrat and City hospital Gujrat. This study will be completed within duration of 6 months after the approval of synopsis.Convenience sampling technique will be used to collect the data. A sample size of total 20 patientswill be taken in the study. 20participants will be equally divided into two group's myofascial stretch and contract-relax stretching techniques having 10participants in each group. Informed consent will be sought from them and they will be clearly explained about the purpose of study.Myofascial Stretching will be applied to Group A and Contract-Relax stretching will be applied to Group B.
Results will be analyzed on SPSS.
Read the detailed description
Cerebral palsy (CP) is primarily a neuromotor disorder that affects the development of movement, muscle tone and posture. The underlying pathophysiology is an injury to the developing brain in the prenatal through neonatal period. Although the initial neuropathologic lesion is non-progressive, children with CP may develop a range of secondary conditions over time that will variably affect their functional abilities.
Cerebral palsy refers to set of lifelong mobility issues and postural defects which restrict function caused by non-progressive abnormalities in growing foetus or neonatal brain. CP is frequently followed by sensory, cognitive, behavioural impairment and musculoskeletal difficulties. CP could categorised as spastic, athetoid, ataxic, or mixed, also classed as hemiplegia, diplegia, quadriplegia, depending on kind of mobility dysfunction. Spasticity of numerous muscle groups is common in CP due to CNS injury
- Conditions
- Cerebral Palsy
- Being tested
- MYOFASCIAL STRETCH, CONTRACT-RELAX TECHNIQUE
- Keywords
- Myofascial stretch, Contract-Relax, Upper Limb
- 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 STRETCHOther
Group A 10 participants will receive Myofascial Stretching
CONTRACT-RELAX TECHNIQUEOther
group B 10 participants will receive Control-Relax Stretching Technique.
| Study group | Role | What they receive |
|---|---|---|
| EFFECTS OF MYOFASCIAL STRETCH | Experimental | This group will receive Myofascial stretch Group. Receives: Other: MYOFASCIAL STRETCH |
| CONTRACT-RELAX TECHNIQUE ON TONE | Experimental | This group will receive Contract-Relax technique Group Receives: Other: CONTRACT-RELAX TECHNIQUE |
What is being measured
The primary outcome is the main question the study is designed to answer.
Manual Ability Classification system
Psychometric properties of the MACS have been assessed with analysis of content, criterion, construct validity, and reliability. The intraclass correlation coefficient between therapists was 0.97 (95% confidence interval 0.96-0.98), and between parents and therapist was 0.96 (0.89-0.98), indicating excellent agreement
Measured: 4 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Mar 2024
- Study start1 Dec 2023
- Primary completion16 Mar 2024
- Study completion25 Mar 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- Riphah International University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Mirza Muhammad Farooq, MS*, Principal investigator, Riphah International University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06292507
- Sponsor's protocol ID
- REC/RCR&AHS/23/0734
- Status last verified
- Jun 2024
- First submitted
- 26 Dec 2023
- Last updated
- 13 Jun 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Choudhary A, Gulati S, Kabra M, Singh UP, Sankhyan N, Pandey RM, Kalra V. Efficacy of modified constraint induced movement therapy in improving upper limb function in children with hemiplegic cerebral palsy: a randomized controlled trial. Brain Dev. 2013 Oct;35(9):870-6. doi: 10.1016/j.braindev.2012.11.001. Epub 2012 Dec 11.
PubMed 23238223
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
- Comparative Effects of Myofascial Stretch and Contract-relax Technique on Tone and Function of Upper Limb in Children With Spastic Cerebral Palsy
- ClinicalTrials.gov ID
- NCT06292507
- Acronym / sponsor ID
- REC/RCR&AHS/23/0734
- Conditions
- Cerebral Palsy
- Keywords
- Myofascial stretch, Contract-Relax, Upper Limb
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- Riphah International UniversityUniversity, hospital or other
- Study start
- 1 Dec 2023 (actual)
- Primary completion
- 16 Mar 2024 (actual)
- Study completion
- 25 Mar 2024 (actual)
- First posted
- 5 Mar 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 primarily a neuromotor disorder that affects the development of movement, muscle tone and posture.It is one of the three most common lifelong developmental disabilities, the other two being autism and mental retardation causing considerable hardship to affected individuals and their families. CP is a common problem, the worldwide incidence being 2 to 2.5 per 1000 live births. Myofascial therapy is definable by "the facilitation of mechanical, neural and psycho physiological adaptive potential as interfaced by the myofascial system". The PNF contract-relax technique consists of stretching the target muscle, keeping it in position while the patient isometrically contracts it and relaxes in sequence, producing effects such as maintenance and gain in joint mobility, increased muscle strength, and better motor control whereas The modified Ashworth scale is the most universally accepted clinical tool used to measure the increase of muscle tone This study will be randomized clinical trial and will be conducted in Rasool medical centre Gujrat and City hospital Gujrat. This study will be completed within duration of 6 months after the approval of synopsis.Convenience sampling technique will be used to collect the data. A sample size of total 20 patientswill be taken in the study. 20participants will be equally divided into two group's myofascial stretch and contract-relax stretching techniques having 10participants in each group. Informed consent will be sought from them and they will be clearly explained about the purpose of study.Myofascial Stretching will be applied to Group A and Contract-Relax stretching will be applied to Group B.
Results will be analyzed on SPSS.
Detailed description
Cerebral palsy (CP) is primarily a neuromotor disorder that affects the development of movement, muscle tone and posture. The underlying pathophysiology is an injury to the developing brain in the prenatal through neonatal period. Although the initial neuropathologic lesion is non-progressive, children with CP may develop a range of secondary conditions over time that will variably affect their functional abilities.
Cerebral palsy refers to set of lifelong mobility issues and postural defects which restrict function caused by non-progressive abnormalities in growing foetus or neonatal brain. CP is frequently followed by sensory, cognitive, behavioural impairment and musculoskeletal difficulties. CP could categorised as spastic, athetoid, ataxic, or mixed, also classed as hemiplegia, diplegia, quadriplegia, depending on kind of mobility dysfunction. Spasticity of numerous muscle groups is common in CP due to CNS injury
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| EFFECTS OF MYOFASCIAL STRETCH | Experimental | Other: MYOFASCIAL STRETCHThis group will receive Myofascial stretch Group. |
| CONTRACT-RELAX TECHNIQUE ON TONE | Experimental | Other: CONTRACT-RELAX TECHNIQUEThis group will receive Contract-Relax technique Group |
Who may qualify
- Ages
- 6 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Age between 6 and 12 year(20).
- Spastic CP child will be including.
- Communication statusand oriented.
- Informed written consent of the children's parents was required.
Key exclusion criteria (4 listed)
- Orthopedic surgery on upper limb(1).
- Received botulinum toxin injection in the upper limb during the last 6 months or who wish to receive it within the period of study(2).
- Upper Extremities deformities
- Upper limb Contracture Formation
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 STRETCHGroup A 10 participants will receive Myofascial Stretching | Other | EFFECTS OF MYOFASCIAL STRETCH |
| CONTRACT-RELAX TECHNIQUEgroup B 10 participants will receive Control-Relax Stretching Technique. | Other | CONTRACT-RELAX TECHNIQUE ON TONE |
Primary outcome
Manual Ability Classification system
Time frame: 4 month
Psychometric properties of the MACS have been assessed with analysis of content, criterion, construct validity, and reliability. The intraclass correlation coefficient between therapists was 0.97 (95% confidence interval 0.96-0.98), and between parents and therapist was 0.96 (0.89-0.98), indicating excellent agreement
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 23238223Choudhary A, Gulati S, Kabra M, Singh UP, Sankhyan N, Pandey RM, Kalra V. Efficacy of modified constraint induced movement therapy in improving upper limb function in children with hemiplegic cerebral palsy: a randomized controlled trial. Brain Dev. 2013 Oct;35(9):870-6. doi: 10.1016/j.braindev.2012.11.001. Epub 2012 Dec 11.
- 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.
Mirza Muhammad Farooq, 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 STRETCH and CONTRACT-RELAX TECHNIQUE 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 4 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?
Manual Ability Classification system (time frame: 4 month). 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 NCT06292507, 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.