Cerebral Palsy, Functional Massage, Myofacial StretchNCT05392335
Myofascial Stretch With And Without Functional Massage In Children With Cerebral Palsy
A study testing Myofascial stretch and Functional massage along with myofacial stretch in people with Cerebral Palsy, Functional Massage, Myofacial Stretch, run by Riphah International University at 1 site in Pakistan.
Trial summary
Cerebral palsy is one of the most common childhood disabilities, and it occurs with an incidence of 2-2.5 per 1000 living births. Children with CP have various impairments including neuromuscular and musculoskeletal problems such as spasticity, dyscoordination, loss of selective motor control, and weakness. Read more about this study
- Who is it for?
- Ages 6 to 12 years
- Conditions the study is for
- Cerebral Palsy, Functional Massage, Myofacial Stretch
- What is being tested?
- Myofascial stretch and Functional massage along with myofacial stretch
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 22 participants
- Where
- 1 sitePakistan
- Study dates
- 13 May 2022to 20 Jan 2023
- 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 of 6 and 12 year
- Both genders
- Children between level Ⅰ- Ⅳ based on Gross Motor Classification System(GMFCS)
Who cannot join
- The existence of dyskinesia or dystonia
- History of muscle lengthening surgery
- Presence of uncontrolled seizures
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects Of Myofascial Stretch With And Without Functional Massage On Spasticity And Gross Motor Function In Children With Cerebral Palsy
Cerebral palsy is one of the most common childhood disabilities, and it occurs with an incidence of 2-2.5 per 1000 living births. Children with CP have various impairments including neuromuscular and musculoskeletal problems such as spasticity, dyscoordination, loss of selective motor control, and weakness. CP can be classified according to the severity of motor deficits as mild, moderate, or severe. Several other classification systems exist based on the pathophysiology, etiology, and distribution of motor deficits. The aim of the study to evaluate the effects of functional massage and myofascial stretch on spasticity and motor function of CP Children. Study will be conducted in 22 patients in experimental and control group. Pre and Post values will be evaluated. The tools used will be Modified Ashworth Scale (MAS) and Gross Motor Function Measure (GMFM). The significance of this study is that it will define for us that to how much extent we can improve the Spastic and painful condition of lower limb of CP child. Data will be analyzed using SPSS 22.0 mean and standard deviation will be calculated. Appropriate the statistical test will be used after checking normality of data.
- Being tested
- Myofascial stretch, Functional massage along with myofacial stretch
- 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
Myofascial stretch will be applied at hip adductors, hamstrings and calf muscles for 10 -15 repetitions on each muscle. 2-3 sessions will be performed in a week for 8 weeks.
Functional massage along with myofacial stretchOther
In this group during the first 20 minutes, ten minutes FM will be applied to each lower extremity of the subject. The muscle groups to which FM would be applied were hip adductors, hamstrings and calf muscles. During the remaining period traditional physiotherapy involving myofascial strecth will be given. 2-3 session will be performed in a week for 8 weeks.
| Study group | Role | What they receive |
|---|---|---|
| myofascial stretch group | Active comparator | Patients will be given myofascial stretch Receives: Other: Myofascial stretch |
| Functional massage along with myofascial stretch group | Experimental | patients will be given functional massage along with myofascial stretching Receives: Other: Myofascial stretch; Other: Functional massage along with myofacial stretch |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in scores of Modified Ashworth scale
The modified Ashworth scale(MAS) is a 6-point rating scale that is used to measure muscle tone.(20) The reliability of the modified Ashworth scale was very good (κw = .84 for inter rater and .83 for intra-rater comparisons)
Measured: Baseline and 8th week
Change in scores of GMFM 88
The GMFM is a standardized observational instrument designed and validated to measure change in gross motor function over time in children with cerebral palsy. The scoring key is meant to be a general guideline. However, most of the items have specific descriptors for each score. It is imperative that the guidelines contained in the manual be used for scoring each item. SCORING KEY 0 = does not initiate 1 = initiates 2 = partially completes 3 = completes 9 (or leave blank) = not tested (NT)
Measured: Baseline and 8th week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 May 2022
- Study start13 May 2022
- Primary completion16 Jan 2023
- Study completion20 Jan 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Cerebral Palsy, Functional Massage, Myofacial StretchStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- Riphah International University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Fareeha Kausar, PP-DPT, Principal investigator, Riphah International University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05392335
- Sponsor's protocol ID
- REC/RCR & AHS/22/0705
- Status last verified
- Mar 2023
- First submitted
- 23 May 2022
- Last updated
- 16 Mar 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Mahmood Q, Habibullah S, Babur MN. Potential effects of traditional massage on spasticity and gross motor function in children with spastic cerebral palsy: A randomized controlled trial. Pak J Med Sci. 2019 Sep-Oct;35(5):1210-1215. doi: 10.12669/pjms.35.5.478.
PubMed 31488980BİNGÖL H, YILMAZ Ö. Effects of functional massage on spasticity and motor functions in children with cerebral palsy: a randomized controlled study. Journal of Exercise Therapy and Rehabilitation. 2018;5(3):135-42.
Bingöl H, Akaras E, Kocaman H. The effects of massage therapy on symptoms related cerebral palsy in children with cerebral palsy: A systematic review. Journal of Clinical Medicine of Kazakhstan. 2020;4(58):6-14.
Kuruma H, Takei H, Nitta O, Furukawa Y, Shida N, Kamio H, et al. Effects of Myofascial Release and Stretching Technique on Range of Motion and Reaction Time. Journal of Physical Therapy Science. 2013;25(2):169-71.
Study at a glance
From the registry record, last updated by the sponsor on 16 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects Of Myofascial Stretch With And Without Functional Massage On Spasticity And Gross Motor Function In Children With Cerebral Palsy
- ClinicalTrials.gov ID
- NCT05392335
- Acronym / sponsor ID
- REC/RCR & AHS/22/0705
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- Riphah International UniversityUniversity, hospital or other
- Study start
- 13 May 2022 (actual)
- Primary completion
- 16 Jan 2023 (actual)
- Study completion
- 20 Jan 2023 (actual)
- First posted
- 26 May 2022 (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 is one of the most common childhood disabilities, and it occurs with an incidence of 2-2.5 per 1000 living births. Children with CP have various impairments including neuromuscular and musculoskeletal problems such as spasticity, dyscoordination, loss of selective motor control, and weakness. CP can be classified according to the severity of motor deficits as mild, moderate, or severe. Several other classification systems exist based on the pathophysiology, etiology, and distribution of motor deficits. The aim of the study to evaluate the effects of functional massage and myofascial stretch on spasticity and motor function of CP Children. Study will be conducted in 22 patients in experimental and control group. Pre and Post values will be evaluated. The tools used will be Modified Ashworth Scale (MAS) and Gross Motor Function Measure (GMFM). The significance of this study is that it will define for us that to how much extent we can improve the Spastic and painful condition of lower limb of CP child. Data will be analyzed using SPSS 22.0 mean and standard deviation will be calculated. Appropriate the statistical test will be used after checking normality of data.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| myofascial stretch group | Active comparator | Other: Myofascial stretchPatients will be given myofascial stretch |
| Functional massage along with myofascial stretch group | Experimental | Other: Myofascial stretch, Other: Functional massage along with myofacial stretchpatients will be given functional massage along with myofascial stretching |
Who may qualify
- Ages
- 6 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Age of 6 and 12 year
- Both genders
- Children between level Ⅰ- Ⅳ based on Gross Motor Classification System(GMFCS)
Key exclusion criteria (3 listed)
- The existence of dyskinesia or dystonia
- History of muscle lengthening surgery
- Presence of uncontrolled seizures
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 stretchMyofascial stretch will be applied at hip adductors, hamstrings and calf muscles for 10 -15 repetitions on each muscle. 2-3 sessions will be performed in a week for 8 weeks. | Other | Functional massage along with myofascial stretch group, myofascial stretch group |
| Functional massage along with myofacial stretchIn this group during the first 20 minutes, ten minutes FM will be applied to each lower extremity of the subject. The muscle groups to which FM would be applied were hip adductors, hamstrings and calf muscles. During the remaining period traditional physiotherapy involving myofascial strecth will be given. 2-3 session will be performed in a week for 8 weeks. | Other | Functional massage along with myofascial stretch group |
Primary outcome
Change in scores of Modified Ashworth scale
Time frame: Baseline and 8th week
The modified Ashworth scale(MAS) is a 6-point rating scale that is used to measure muscle tone.(20) The reliability of the modified Ashworth scale was very good (κw = .84 for inter rater and .83 for intra-rater comparisons)
Change in scores of GMFM 88
Time frame: Baseline and 8th week
The GMFM is a standardized observational instrument designed and validated to measure change in gross motor function over time in children with cerebral palsy. The scoring key is meant to be a general guideline. However, most of the items have specific descriptors for each score. It is imperative that the guidelines contained in the manual be used for scoring each item. SCORING KEY 0 = does not initiate 1 = initiates 2 = partially completes 3 = completes 9 (or leave blank) = not tested (NT)
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 16 Mar 2023.
- Background: PubMed 31488980Mahmood Q, Habibullah S, Babur MN. Potential effects of traditional massage on spasticity and gross motor function in children with spastic cerebral palsy: A randomized controlled trial. Pak J Med Sci. 2019 Sep-Oct;35(5):1210-1215. doi: 10.12669/pjms.35.5.478.
- BackgroundBİNGÖL H, YILMAZ Ö. Effects of functional massage on spasticity and motor functions in children with cerebral palsy: a randomized controlled study. Journal of Exercise Therapy and Rehabilitation. 2018;5(3):135-42.
- BackgroundBingöl H, Akaras E, Kocaman H. The effects of massage therapy on symptoms related cerebral palsy in children with cerebral palsy: A systematic review. Journal of Clinical Medicine of Kazakhstan. 2020;4(58):6-14.
- BackgroundKuruma H, Takei H, Nitta O, Furukawa Y, Shida N, Kamio H, et al. Effects of Myofascial Release and Stretching Technique on Range of Motion and Reaction Time. Journal of Physical Therapy Science. 2013;25(2):169-71.
- Individual participant dataSharing planned: No
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.
Fareeha Kausar, PP-DPT 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 Functional massage along with myofacial stretch in people with Cerebral Palsy, Functional Massage, Myofacial Stretch, 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 3 inclusion and 3 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 16 Mar 2023. 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?
Change in scores of Modified Ashworth scale (time frame: Baseline and 8th week). The study lists 2 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 NCT05392335, which also lists 4 linked publications.
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 16 Mar 2023.