Down SyndromeDownSyndromeNCT07248449
Physical Fitness in DS: A Comparison of Cuevas Medak and Rebound Exercises
A study testing Cuevas Medak Exercises in people with Down Syndrome, run by Riphah International University at 1 site in Pakistan.
Trial 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. Read more about this study
- Who is it for?
- Ages 3 to 8 yearsHealthy volunteers can take part
- Conditions the study is for
- Down Syndrome
- What is being tested?
- Cuevas Medak Exercises
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 22 participants
- Where
- 1 sitePakistan
- Study dates
- 22 Oct 2025to 30 Jan 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 3 to 8 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 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.
Who cannot join
- Patients with medical conditions that would severely limit their participation in the study
- Hearing loss
- Contracture
- Musculoskeletal disorders,
- Atlanto-axial instability
- Cardiac anomalies
Show all 10Show fewer
- Thyroid abnormality
- Seizures
- Uncorrected vision problems
- Orthopedic surgery or spasticity-reduction intervention
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Pakistan1 site, 1 recruiting
- Recruiting
Muhammad Nouman Ashraf
Lahore, Punjab Province, 54000
Muhammad Asif Jvaed, MS-PT, 923224209422, a.javed@riphah.edu.pk
About this study
Official title: 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
Read the 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
- Conditions
- Down Syndrome
- Being tested
- Cuevas Medak Exercises
- Keywords
- Cuevas Medek Exercise, Rebound Exercise, Down syndrome
- Medical subject headings
- Down Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cuevas Medak ExercisesOther
Also called Rebound 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
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: Cuevas Medak Exercises |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Baseline,12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Nov 2025
- Study start22 Oct 2025
- Primary completion30 Jan 2026 (estimated)
- Study completion30 Jan 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Down SyndromeStudies 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 22 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Riphah International University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ayesha Afzal, MS-PT, Principal investigator, Riphah International University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07248449
- Sponsor's protocol ID
- REC/RCR&AHS/AYESHAAFZAL
- Acronym
- DownSyndrome
- Status last verified
- Nov 2025
- First submitted
- 18 Nov 2025
- Last updated
- 25 Nov 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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.
PubMed 31357594
Study at a glance
From the registry record, last updated by the sponsor on 25 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Cuevas Medak Exercises Vs Rebound Exercises on Physical Fitness in Children With Down Syndrome
- ClinicalTrials.gov ID
- NCT07248449
- Acronym / sponsor ID
- DownSyndrome / REC/RCR&AHS/AYESHAAFZAL
- Conditions
- Down Syndrome
- Keywords
- Cuevas Medek Exercise, Rebound Exercise, Down syndrome
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 22 participants (estimated)
- Lead sponsor
- Riphah International UniversityUniversity, hospital or other
- Study start
- 22 Oct 2025 (actual)
- Primary completion
- 30 Jan 2026 (estimated)
- Study completion
- 30 Jan 2026 (estimated)
- First posted
- 25 Nov 2025 (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.
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
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- 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
| Arm | Type | Receives |
|---|---|---|
| Experimental:11 children of DS will be given Cuevas Medak Exercises for 12 weeks | Experimental | Other: Cuevas Medak ExercisesBaseline 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. |
| Expermental:11 children of DS will be given Rebound Exercises for 15 min | Experimental | Other: Cuevas Medak ExercisesGroup 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. |
Who may qualify
- Ages
- 3 to 8 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (10 listed)
- Patients with medical conditions that would severely limit their participation in the study
- Hearing loss
- Contracture
- Musculoskeletal disorders,
- Atlanto-axial instability
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 |
|---|---|---|
| Cuevas Medak ExercisesAlso: Rebound ExercisesGroup 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 | Experimental:11 children of DS will be given Cuevas Medak Exercises for 12 weeks, Expermental:11 children of DS will be given Rebound Exercises for 15 min |
Primary outcome
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Nov 2025.
- Background: PubMed 31357594Cabeza-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.
- Individual participant dataSharing planned: No
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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.
Ayesha Afzal, MS-PT 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 Cuevas Medak Exercises in people with Down Syndrome, 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 4 inclusion and 10 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: looking for participants now, as of the sponsor's last update on 25 Nov 2025. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact IMRAN, PhD AMJAD, PHD (9233224390125, imran.amjad@riphah.edu.pk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
SAMU-DISFITT Battery for Physical fitness (time frame: Baseline,12 weeks). 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 NCT07248449, which also lists 1 linked publication.
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 25 Nov 2025.