- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07248449
Physical Fitness in DS: A Comparison of Cuevas Medak and Rebound Exercises (DownSyndrome)
Effects of Cuevas Medak Exercises Vs Rebound Exercises on Physical Fitness in Children With Down Syndrome
This randomized clinical trial investigates the comparative effects of Cuevas Medak Exercises Vs Rebound Exercises on physical fitness in DS. The.current study will be single blinded randomized clinical design in which nonprobability convenience sampling technique will be used. Inclusion criteria will be Down Syndrome. both genders will be included. The study involves 22 DS aged 3-8, will be assigned using lottery method, the participants will be randomly divided into two groups. One group will be given Cuevas Medek Exercises and the other with Rebound exercises. SAMU-Disability Fitness (DISFIT) battery will be used to assess the Physical Fitness in Down syndrome. Both groups will be given three treatment session per week for 12 weeks and total time for each session will be 30-45 minutes.
. Data will be analyzed through SPSS version 26.0
Study Overview
Detailed Description
Down syndrome is usually associated with developmental delays, mild to moderate intellectual disability, and characteristic physical features. Children with DS usually encounter problems with the motor function as a result of decreased muscle tone, ligamentous laxity, decreased muscle strength, and endurance.
Children with DS experience decreased balance capacity on account of the brain stem and cerebellar hypoplasia leading to disruption of motor function and postural control. DS children have difficulty preserving their body posture which is frequently combined with an abnormality in gait pattern Cuevas Medek Exercises (CME) is a psychomotor therapy approach for rehabilitation programs that involves automatic motor reactions using exercises against gravity provoking the postural control and also describe its neuroplastic outcome. MEDEK is an acronym for a Spanish phrase means "Dynamic Method for Kinesthetic Stimulation infuriating postural control, which is not self-produced due to impaired central nervous system. The main mechanism is to generate new neuronal networks in affected central nervous system by utilizing scientific parameters associated to neuroplasticity (such as repetition, ROM, weight bearing, progression, significant exercises). Down syndrome might be particularly susceptible to loss of basic function because of poor physical fitness. Rebounding exercises are a series of movements based on trampoline exercises, have been used for children with different physical and intellectual disabilities. The Health Bounce, this is a basic movement that involves bouncing up and down on the trampoline.
Rebounding from quality mini trampoline provides all the benefits of other aerobic exercise without the stress impact .The objective of current study is to check the effects of Cuevas Medek exercise VS rebound exercise on physical fitness in children with Down syndrome . The current study will be single blinded randomized clinical design in which nonprobability convenience sampling technique will be used. Inclusion criteria will be Down Syndrome Age ranges between 3-8 yrs, both genders will be included, children who will be able to understand the commands given to them.
Exclusion Criteria will be Patients with medical condition, contracture, musculoskeletal disorders, Atlanta 3 CUEVAS MEDEK EXERCISES VS REBOUND EXERCISES IN DOWN SYNDROME -axial instability, uncorrected vision or orthopedic surgery. Using lottery method, the participants will be randomly divided in to two groups. One group will be given Cuevas Medek Exercises and the other with Rebound exercises. SAMU-Disability Fitness (DISFIT) battery will be used to assess the Physical Fitness in Down syndrome. Both groups will be given three treatment session per week for 12 weeks and total time for each session will be 30-45 minutes. Data will be analyzed by using SPSS v 26.Sample size is 24 and is calculated by epitool
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Muhammad Asif Javed, MS-PT
- Phone Number: 923224209422
- Email: a.javed@riphah.edu.pk
Study Contact Backup
- Name: IMRAN, PhD AMJAD, PHD
- Phone Number: 9233224390125
- Email: imran.amjad@riphah.edu.pk
Study Locations
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Punjab Province
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Lahore, Punjab Province, Pakistan, 54000
- Recruiting
- Muhammad Nouman Ashraf
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Contact:
- Muhammad Asif Jvaed, MS-PT
- Phone Number: 923224209422
- Email: a.javed@riphah.edu.pk
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Children with Down syndrome
- Age 3-8 years Both genders
- Children who were able to understand the commands given to them.
- They were able to stand and walk independently.
Exclusion Criteria:
- Patients with medical conditions that would severely limit their participation in the study
- Hearing loss
- Contracture
- Musculoskeletal disorders,
- Atlanto-axial instability
- Cardiac anomalies
- Thyroid abnormality
- Seizures
- Uncorrected vision problems
- Orthopedic surgery or spasticity-reduction intervention
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Experimental:11 children of DS will be given Cuevas Medak Exercises for 12 weeks
Baseline treatment will be applied to patient through following functional activities.
Core strengthening exercises (isometrics) shall be given as a common treatment.
This involved completing two sets of 15 repetitions with each repetition held for 5 seconds.
The children in group 1 received Cuevas Medek exercise 3 times per week for 3 successive months.
The patient was supported at board at the leg level with slight posterior support to maintain balance.
After being lifted off the ground for a few seconds, gentle up and down oscillations were applied.
The study utilized three wooden boxes with identical dimensions measuring 20cm x 40cm x 60cm each, along with a larger box, a wooden plate, and two planks of equal size measuring 17cm x 80cm.
These items were arranged in various configurations to create structures such as slides, piano flaps, and stairs.
|
Group A 11 children of DS will be given Cuevas Medak Exercises for 12 weeks and total time for each session will be 30-45 min.
Group B 11 children of DS will be given Rebound Exercises for 15 min though this can be broken into multiple 3-5 min
Other Names:
|
|
Experimental: Expermental:11 children of DS will be given Rebound Exercises for 15 min
Group b will receive Rebound exercise.
Baseline treatment will be applied to patient.
The children in group 2 received rebounding exercise 3 times per week for 3 successive months.
Mini trampoline.Each rebounding session consisted of the following schedule: (3 min of rebounding) - (3 min rest) - (3 min of rebounding) - (3 min rest) - (3 min of rebounding).
Thus, one treatment session corresponded to 9 min of rebounding exercise (21).
side sitting and high kneeling); bouncing and / or being bounced without leaving the surface of the trampoline.
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Group A 11 children of DS will be given Cuevas Medak Exercises for 12 weeks and total time for each session will be 30-45 min.
Group B 11 children of DS will be given Rebound Exercises for 15 min though this can be broken into multiple 3-5 min
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
SAMU-DISFITT Battery for Physical fitness
Time Frame: Baseline,12 weeks
|
The SAMU-DISFIT battery is a reliable and feasible physical fitness battery which has been created with the purpose of establishing tests which measure the four basic components of PF (flexibility, cardiorespiratory fitness, musculoskeletal fitness and motor fitness) in DS. physical fitness (PF) of child with DS: Body Mass Index (BMI), Waist Circumference
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Baseline,12 weeks
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Ayesha Afzal, MS-PT, Riphah International University
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- REC/RCR&AHS/AYESHAAFZAL
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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