NCT07248449

Brief Summary

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

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
22

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Oct 2025

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 22, 2025

Completed
27 days until next milestone

First Submitted

Initial submission to the registry

November 18, 2025

Completed
7 days until next milestone

First Posted

Study publicly available on registry

November 25, 2025

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 30, 2026

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 30, 2026

Completed
Last Updated

November 25, 2025

Status Verified

November 1, 2025

Enrollment Period

3 months

First QC Date

November 18, 2025

Last Update Submit

November 18, 2025

Conditions

Keywords

Cuevas Medek Exercise, Rebound Exercise, Down syndrome

Outcome Measures

Primary Outcomes (1)

  • SAMU-DISFITT Battery for Physical fitness

    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

    Baseline,12 weeks

Study Arms (2)

Experimental:11 children of DS will be given Cuevas Medak Exercises for 12 weeks

EXPERIMENTAL

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.

Other: Cuevas Medak Exercises

Expermental:11 children of DS will be given Rebound Exercises for 15 min

EXPERIMENTAL

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.

Other: Cuevas Medak Exercises

Interventions

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

Also known as: Rebound Exercises
Experimental:11 children of DS will be given Cuevas Medak Exercises for 12 weeksExpermental:11 children of DS will be given Rebound Exercises for 15 min

Eligibility Criteria

Age3 Years - 8 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Muhammad Nouman Ashraf

Lahore, Punjab Province, 54000, Pakistan

RECRUITING

Related Publications (1)

  • 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: 31357594BACKGROUND

MeSH Terms

Conditions

Down Syndrome

Condition Hierarchy (Ancestors)

Intellectual DisabilityNeurobehavioral ManifestationsNeurologic ManifestationsNervous System DiseasesAbnormalities, MultipleCongenital AbnormalitiesCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesChromosome DisordersGenetic Diseases, Inborn

Study Officials

  • Ayesha Afzal, MS-PT

    Riphah International University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

IMRAN, PhD AMJAD, PHD

CONTACT

Muhammad Asif Javed, MS-PT

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Masking Details
Participants will get separate treatment protocol and possible efforts will be put to mask the both groups about the treatment.
Purpose
OTHER
Intervention Model
PARALLEL
Model Details: This is a randomized clinical trial (RCT) designed to compare the effectiveness of two different exercises, Cuevas Medak Vs Rebound Exercises on physical Fitness of Down Syndrome. The study will involve 22 participants of both gender between the ages of 3-8 years. These participants will be randomly divided into two groups. children who will be able to understand the commands given to them. 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 by using SPSS v 26.Sample size is 22 and is calculated by epitol
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 18, 2025

First Posted

November 25, 2025

Study Start

October 22, 2025

Primary Completion

January 30, 2026

Study Completion

January 30, 2026

Last Updated

November 25, 2025

Record last verified: 2025-11

Data Sharing

IPD Sharing
Will not share

Locations