- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04966403
Effects of Stretch-shortening Cycle Exercises Postural Control in Down Syndrome
September 8, 2021 updated by: Maged Basha, Qassim University
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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 Type
Interventional
Enrollment (Actual)
32
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Riyadh
-
Al-Kharj, Riyadh, Saudi Arabia
- King Khalid Hospital
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
7 years to 9 years (CHILD)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: SINGLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: standard physical therapy
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.
|
building strength, enhancing developmental skills, boosting balance, coordination, and postural control
Other Names:
|
EXPERIMENTAL: trampoline-based stretch-shortening cycle exercises
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.
|
muscle strength
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
at baseline
|
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
|
after 12 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Postural control index by Balance Biodex System
Time Frame: at baseline
|
Postural stability indices were assessed through the Balance Biodex System (Biodex Medical Systems, Shirley, NY),
|
at baseline
|
Postural control index by Balance Biodex System
Time Frame: after 12 weeks
|
Postural stability indices were assessed through the Balance Biodex System (Biodex Medical Systems, Shirley, NY),
|
after 12 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General 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.
- Aalizadeh 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.
- Champagne 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.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (ACTUAL)
December 1, 2018
Primary Completion (ACTUAL)
August 20, 2019
Study Completion (ACTUAL)
June 5, 2020
Study Registration Dates
First Submitted
July 14, 2021
First Submitted That Met QC Criteria
July 14, 2021
First Posted (ACTUAL)
July 19, 2021
Study Record Updates
Last Update Posted (ACTUAL)
September 16, 2021
Last Update Submitted That Met QC Criteria
September 8, 2021
Last Verified
September 1, 2021
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 0018/0086
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
YES
IPD Plan Description
The data sets generated during and/or analyzed during the current study is available from the corresponding author on reasonable request.
IPD Sharing Time Frame
6 months after publication
IPD Sharing Access Criteria
relevance to the topic of the study and approval of all co-authors within 1 month of receiving the request.
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
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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