to Determine the Effect of Pilate's Exercises on Gross Motor Function and BalanceNCT04615793
Effect of Pilates Exercises on Gross Motor Function and Balance
A study testing PILATES EXERCISES in people with to Determine the Effect of Pilate's Exercises on Gross Motor Function and Balance, run by Badr University at 1 site in Egypt.
Trial summary
the study aimed to asses the effect of Pilate exercise on motor function and balance in diplegic children Read more about this study
- Who is it for?
- Ages 7 to 9 yearsHealthy volunteers can take part
- Conditions the study is for
- to Determine the Effect of Pilate's Exercises on Gross Motor Function and Balance
- What is being tested?
- PILATES EXERCISES
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteEgypt
- Study dates
- 3 Nov 2020to 31 Jan 2021
- 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 7 to 9 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 7 to 9 years,
- mild spasticity of lower limb
- able to understand and follow instructions
Who cannot join
- fixed contracture
- visual or respiratory disorders,
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Pilates Exercises on Gross Motor Function and Balance in Children With Diplegic Cerebral Palsy
the study aimed to asses the effect of Pilate exercise on motor function and balance in diplegic children
- Being tested
- PILATES EXERCISES
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PILATES EXERCISESOther
The experimental group will receive Pilates exercises focusing on lower limb strength, flexibility and coordination in addition to exercises given to control group. Exercises or movements were done on a mat, on an exercise ball or in standing position while emphasizing on spinal and pelvic alignment, maintaining core contraction and the rhythm of respiration. All exercises were done for 10 repetitions with a rest period of two minutes before commencing the next exercise, and lasted for about 45 minutes. All the groups will receive the above mentioned interventions thrice in a week for a period of 10 week
| Study group | Role | What they receive |
|---|---|---|
| CONTROL GROUP | No intervention | The control group will receive flexibility exercises and strength training focusing on the trunk and lower limb muscles, postural control exercise in different positions and different surfaces and general endurance training . Control group will receive intervention in the form of five minutes warm up followed by 12 minutes of walking at their comfortable pace and concluded with a five minutes cool down |
| EXPERMINTAL GROUP | Experimental | The experimental group will obtain Pilate exercises, consist of strengthening,stretching and coordinated exercises on lower and trunk muscle Receives: Other: PILATES EXERCISES |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Pediatric Balance Scale
The PBS is a modified version of the Berg balance scale, which is designed to evaluate balance in children with mild to moderate motor impairment. Fifty-six points is the maximum score . This scale evaluates performance of fourteen activities common in everyday life.
Measured: pre and after 10 week of intervention, the maximum score is 56, so increase the score indicate improvement
Secondary outcomes (1)
Gross motor function
gross motor function consist of 5 dimensions.
Measured: pre and after 10 week of intervension. increase the percentage indicate improvement
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Nov 2020
- Study start3 Nov 2020
- Primary completion1 Jan 2021
- Study completion31 Jan 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for to Determine the Effect of Pilate's Exercises on Gross Motor Function and BalanceStudies of the same condition, open and under way.
- 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
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Badr University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, hanaa mohsen, Badr University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04615793
- Sponsor's protocol ID
- P.T.REC/012/002914
- Status last verified
- Jun 2021
- First submitted
- 28 Oct 2020
- Last updated
- 15 Jun 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 15 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Pilates Exercises on Gross Motor Function and Balance in Children With Diplegic Cerebral Palsy
- ClinicalTrials.gov ID
- NCT04615793
- Acronym / sponsor ID
- P.T.REC/012/002914
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Badr UniversityUniversity, hospital or other
- Study start
- 3 Nov 2020 (actual)
- Primary completion
- 1 Jan 2021 (actual)
- Study completion
- 31 Jan 2021 (actual)
- First posted
- 4 Nov 2020 (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.
the study aimed to asses the effect of Pilate exercise on motor function and balance in diplegic children
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CONTROL GROUP | No intervention | –The control group will receive flexibility exercises and strength training focusing on the trunk and lower limb muscles, postural control exercise in different positions and different surfaces and general endurance training . Control group will receive intervention in the form of five minutes warm up followed by 12 minutes of walking at their comfortable pace and concluded with a five minutes cool down |
| EXPERMINTAL GROUP | Experimental | Other: PILATES EXERCISESThe experimental group will obtain Pilate exercises, consist of strengthening,stretching and coordinated exercises on lower and trunk muscle |
Who may qualify
- Ages
- 7 to 9 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- 7 to 9 years,
- mild spasticity of lower limb
- able to understand and follow instructions
Key exclusion criteria (2 listed)
- fixed contracture
- visual or respiratory disorders,
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 |
|---|---|---|
| PILATES EXERCISESThe experimental group will receive Pilates exercises focusing on lower limb strength, flexibility and coordination in addition to exercises given to control group. Exercises or movements were done on a mat, on an exercise ball or in standing position while emphasizing on spinal and pelvic alignment, maintaining core contraction and the rhythm of respiration. All exercises were done for 10 repetitions with a rest period of two minutes before commencing the next exercise, and lasted for about 45 minutes. All the groups will receive the above mentioned interventions thrice in a week for a period of 10 week | Other | EXPERMINTAL GROUP |
Primary outcome
The Pediatric Balance Scale
Time frame: pre and after 10 week of intervention, the maximum score is 56, so increase the score indicate improvement
The PBS is a modified version of the Berg balance scale, which is designed to evaluate balance in children with mild to moderate motor impairment. Fifty-six points is the maximum score . This scale evaluates performance of fourteen activities common in everyday life.
1 secondary outcome
Gross motor function
Time frame: pre and after 10 week of intervension. increase the percentage indicate improvement
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 15 Jun 2021.
- Individual participant dataSharing planned: Undecided
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PILATES EXERCISES in people with to Determine the Effect of Pilate's Exercises on Gross Motor Function and Balance, run by Badr University at 1 site in Egypt.
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 2 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 15 Jun 2021. 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 Egypt. 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?
The Pediatric Balance Scale (time frame: pre and after 10 week of intervention, the maximum score is 56, so increase the score indicate improvement). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 15 Jun 2021.