Down SyndromeNCT04966403
Effects of Stretch-shortening Cycle Exercises Postural Control in Down Syndrome
A study testing Standard physical therapy and trampoline-based stretch-shortening cycle exercises in people with Down Syndrome, run by Qassim University at 1 site in Saudi Arabia.
Trial summary
To investigate the effect of a 3-month, trampoline-based stretch-shortening cycle (SSC) exercises on muscle strength and postural control in children with Down syndrome. Read more about this study
- Who is it for?
- Ages 7 to 9 years
- Conditions the study is for
- Down Syndrome
- What is being tested?
- Standard physical therapy and trampoline-based stretch-shortening cycle exercises
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 1 siteSaudi Arabia
- Study dates
- 1 Dec 2018to 5 Jun 2020
- 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
- No healthy volunteers
- Child
Who may be able to join
- age between 7 and 9 years.
- able to follow one step motor commands.
- independent ambulators.
- not suffering from atlantoaxial joint instability as reported from their medical files.
Who cannot join
- Children with un-corrected cardiac anomalies.
- Children with un-corrected vision or hearing loss.
- Children with un-corrected pulmonary disorders.
- Children with un-corrected neurological signs as epilepsy.
- Children who had a history of musculoskeletal surgery in the lower extremities through the past year.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Distinct Effects of Trampoline-based Stretch-shortening Cycle Exercises on Muscle Strength and Postural Control in Children With Down Syndrome: A Randomized Controlled Study
To investigate the effect of a 3-month, trampoline-based stretch-shortening cycle (SSC) exercises on muscle strength and postural control in children with Down syndrome.
Read the detailed description
a variety of physical therapy techniques are being used to improve lower limb muscle strength and postural control in children with Down syndrome including, but not limited to, progressive resistance training, hippotherapy, aquatic therapy, and isokinetic strength training. Stretch-shortening (SSC) exercises-also referred to as plyometric exercises, is a traditional form of resistance training that involves three-phase muscle contraction during dynamic movements (like jumping and hopping), where the muscle moves rapidly through the eccentric, isometric, and concentric phases.
- Conditions
- Down Syndrome
- Being tested
- Standard physical therapy, trampoline-based stretch-shortening cycle exercises
- Medical subject headings
- Down Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Standard physical therapyOther
Also called physical fitness
building strength, enhancing developmental skills, boosting balance, coordination, and postural control
trampoline-based stretch-shortening cycle exercisesOther
Also called postural control
muscle strength
| Study group | Role | What they receive |
|---|---|---|
| standard physical therapy | Experimental | Participants in the standard physical therapy received the standard physical therapy (sPT) program, which was conducted according to the needs of each participant and was generally concerned with building strength, enhancing developmental skills, boosting balance, coordination, and postural control, improving physical fitness, and minimizing the development of the compensatory movement patterns that children with DS are likely to develop. Receives: Other: Standard physical therapy |
| trampoline-based stretch-shortening cycle exercises | Experimental | In addition to the sPT, the SSC group received 15-minute SSC exercise sessions, twice weekly, with a total of 24 sessions over 12 successive weeks. Receives: Other: trampoline-based stretch-shortening cycle exercises |
What is being measured
The primary outcome is the main question the study is designed to answer.
Grade of Muscle strength by hand-held dynamometer
A calibrated hand-held dynamometer (Micro FET2, Hoggan Health Technologies Inc., UT, USA) was used
Measured: at baseline
Grade of Muscle strength by hand-held dynamometer
A calibrated hand-held dynamometer (Micro FET2, Hoggan Health Technologies Inc., UT, USA) was used
Measured: after 12 weeks
Secondary outcomes (2)
Postural control index by Balance Biodex System
Postural stability indices were assessed through the Balance Biodex System (Biodex Medical Systems, Shirley, NY),
Measured: at baseline
Postural control index by Balance Biodex System
Postural stability indices were assessed through the Balance Biodex System (Biodex Medical Systems, Shirley, NY),
Measured: after 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jul 2021
- Study start1 Dec 2018
- Primary completion20 Aug 2019
- Study completion5 Jun 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Down SyndromeStudies 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
- Outcomes assessor
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- Qassim University
- Sponsor type
- University, hospital or other
- Collaborators
- Cairo University, Prince Sattam Bin Abdulaziz University
- Responsible party
- Principal investigator, Maged Basha, Qassim University
- Investigators
- Alshimaa Azab, PhD, Study director, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04966403
- Sponsor's protocol ID
- 0018/0086
- Status last verified
- Sep 2021
- First submitted
- 14 Jul 2021
- Last updated
- 16 Sep 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The data sets generated during and/or analyzed during the current study is available from the corresponding author on reasonable request.
Publications
Alsakhawi RS, Elshafey MA. Effect of Core Stability Exercises and Treadmill Training on Balance in Children with Down Syndrome: Randomized Controlled Trial. Adv Ther. 2019 Sep;36(9):2364-2373. doi: 10.1007/s12325-019-01024-2. Epub 2019 Jul 12.
PubMed 31301057Aalizadeh B, Mohammadzadeh H, Khazani A, Dadras A. Effect of a Trampoline Exercise on the Anthropometric Measures and Motor Performance of Adolescent Students. Int J Prev Med. 2016 Jul 13;7:91. doi: 10.4103/2008-7802.186225. eCollection 2016.
PubMed 27512557Champagne D, Dugas C. Improving gross motor function and postural control with hippotherapy in children with Down syndrome: case reports. Physiother Theory Pract. 2010 Nov;26(8):564-71. doi: 10.3109/09593981003623659. Epub 2010 Jul 31.
PubMed 20673078
Study at a glance
From the registry record, last updated by the sponsor on 16 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Distinct Effects of Trampoline-based Stretch-shortening Cycle Exercises on Muscle Strength and Postural Control in Children With Down Syndrome: A Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT04966403
- Acronym / sponsor ID
- 0018/0086
- Conditions
- Down Syndrome
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Qassim UniversityUniversity, hospital or other
- Collaborators
- Cairo University, Prince Sattam Bin Abdulaziz University
- Study start
- 1 Dec 2018 (actual)
- Primary completion
- 20 Aug 2019 (actual)
- Study completion
- 5 Jun 2020 (actual)
- First posted
- 19 Jul 2021 (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.
To investigate the effect of a 3-month, trampoline-based stretch-shortening cycle (SSC) exercises on muscle strength and postural control in children with Down syndrome.
Detailed description
a variety of physical therapy techniques are being used to improve lower limb muscle strength and postural control in children with Down syndrome including, but not limited to, progressive resistance training, hippotherapy, aquatic therapy, and isokinetic strength training. Stretch-shortening (SSC) exercises-also referred to as plyometric exercises, is a traditional form of resistance training that involves three-phase muscle contraction during dynamic movements (like jumping and hopping), where the muscle moves rapidly through the eccentric, isometric, and concentric phases.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| standard physical therapy | Experimental | Other: Standard physical therapyParticipants in the standard physical therapy received the standard physical therapy (sPT) program, which was conducted according to the needs of each participant and was generally concerned with building strength, enhancing developmental skills, boosting balance, coordination, and postural control, improving physical fitness, and minimizing the development of the compensatory movement patterns that children with DS are likely to develop. |
| trampoline-based stretch-shortening cycle exercises | Experimental | Other: trampoline-based stretch-shortening cycle exercisesIn addition to the sPT, the SSC group received 15-minute SSC exercise sessions, twice weekly, with a total of 24 sessions over 12 successive weeks. |
Who may qualify
- Ages
- 7 to 9 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- age between 7 and 9 years.
- able to follow one step motor commands.
- independent ambulators.
- not suffering from atlantoaxial joint instability as reported from their medical files.
Key exclusion criteria (5 listed)
- Children with un-corrected cardiac anomalies.
- Children with un-corrected vision or hearing loss.
- Children with un-corrected pulmonary disorders.
- Children with un-corrected neurological signs as epilepsy.
- Children who had a history of musculoskeletal surgery in the lower extremities through the past year.
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 |
|---|---|---|
| Standard physical therapyAlso: physical fitnessbuilding strength, enhancing developmental skills, boosting balance, coordination, and postural control | Other | standard physical therapy |
| trampoline-based stretch-shortening cycle exercisesAlso: postural controlmuscle strength | Other | trampoline-based stretch-shortening cycle exercises |
Primary outcome
Grade of Muscle strength by hand-held dynamometer
Time frame: at baseline
A calibrated hand-held dynamometer (Micro FET2, Hoggan Health Technologies Inc., UT, USA) was used
Grade of Muscle strength by hand-held dynamometer
Time frame: after 12 weeks
A calibrated hand-held dynamometer (Micro FET2, Hoggan Health Technologies Inc., UT, USA) was used
2 secondary outcomes
Postural control index by Balance Biodex System
Time frame: at baseline
Postural control index by Balance Biodex System
Time frame: after 12 weeks
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 16 Sep 2021.
- Background: PubMed 31301057Alsakhawi RS, Elshafey MA. Effect of Core Stability Exercises and Treadmill Training on Balance in Children with Down Syndrome: Randomized Controlled Trial. Adv Ther. 2019 Sep;36(9):2364-2373. doi: 10.1007/s12325-019-01024-2. Epub 2019 Jul 12.
- Results publication: PubMed 27512557Aalizadeh B, Mohammadzadeh H, Khazani A, Dadras A. Effect of a Trampoline Exercise on the Anthropometric Measures and Motor Performance of Adolescent Students. Int J Prev Med. 2016 Jul 13;7:91. doi: 10.4103/2008-7802.186225. eCollection 2016.
- Results publication: PubMed 20673078Champagne D, Dugas C. Improving gross motor function and postural control with hippotherapy in children with Down syndrome: case reports. Physiother Theory Pract. 2010 Nov;26(8):564-71. doi: 10.3109/09593981003623659. Epub 2010 Jul 31.
- Individual participant dataSharing planned: Yes. The data sets generated during and/or analyzed during the current study is available from the corresponding author on reasonable request.
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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. This study is not recruiting at the moment.
Alshimaa Azab, PhD study director
Cairo 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 Standard physical therapy and trampoline-based stretch-shortening cycle exercises in people with Down Syndrome, run by Qassim University at 1 site in Saudi Arabia.
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 5 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 16 Sep 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 Saudi Arabia. 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?
Grade of Muscle strength by hand-held dynamometer (time frame: at baseline). The study lists 2 primary outcomes in all. 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 NCT04966403, which also lists 3 linked publications.
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 16 Sep 2021; AzTrials last refreshed its copy on 26 Oct 2026.