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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04966403
Other study ID # 0018/0086
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date December 1, 2018
Est. completion date June 5, 2020

Study information

Verified date September 2021
Source Qassim University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 32
Est. completion date June 5, 2020
Est. primary completion date August 20, 2019
Accepts healthy volunteers No
Gender All
Age group 7 Years to 9 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Other:
Standard physical therapy
building strength, enhancing developmental skills, boosting balance, coordination, and postural control
trampoline-based stretch-shortening cycle exercises
muscle strength

Locations

Country Name City State
Saudi Arabia King Khalid Hospital Al-Kharj Riyadh

Sponsors (3)

Lead Sponsor Collaborator
Qassim University Cairo University, Prince Sattam Bin Abdulaziz University

Country where clinical trial is conducted

Saudi Arabia, 

References & Publications (3)

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Grade of Muscle strength by hand-held dynamometer A calibrated hand-held dynamometer (Micro FET2, Hoggan Health Technologies Inc., UT, USA) was used at baseline
Primary Grade of Muscle strength by hand-held dynamometer A calibrated hand-held dynamometer (Micro FET2, Hoggan Health Technologies Inc., UT, USA) was used after 12 weeks
Secondary Postural control index by Balance Biodex System Postural stability indices were assessed through the Balance Biodex System (Biodex Medical Systems, Shirley, NY), at baseline
Secondary Postural control index by Balance Biodex System Postural stability indices were assessed through the Balance Biodex System (Biodex Medical Systems, Shirley, NY), after 12 weeks
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