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Recruiting NCT07248449

Physical Fitness in DS: A Comparison of Cuevas Medak and Rebound Exercises

No phase Interventional Down Syndrome

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Cuevas Medak Exercises.
Who it may be relevant to
Registry conditions: Down Syndrome. Basic parameters: 3 years — 8 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Pakistan
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

Effects of Cuevas Medak Exercises Vs Rebound Exercises on Physical Fitness in Children With Down Syndrome

Overview

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

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

Interventions

  • Other Cuevas Medak Exercises
    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

Primary outcome measures

  • SAMU-DISFITT Battery for Physical fitness [Time frame: Baseline,12 weeks]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Single blind
Primary purpose
Other

Study locations

Pakistan · 1 center
  • Muhammad Nouman Ashraf — Lahore

Publications

  • Cabeza-Ruiz R, Alcantara-Cordero FJ, Ruiz-Gavilan I, Sanchez-Lopez AM. Feasibility and Reliability of a Physical Fitness Test Battery in Individuals with Down Syndrome. Int J Environ Res Public Health. 2019 Jul 27;16(15):2685. doi: 10.3390/ijerph16152685. PMID 31357594

Identifiers

NCT: NCT07248449 · REC/RCR&AHS/AYESHAAFZAL

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗