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Effects of Stretch-shortening Cycle Exercises Postural Control in Down Syndrome

Primary Purpose

Down Syndrome

Status
Completed
Phase
Not Applicable
Locations
Saudi Arabia
Study Type
Interventional
Intervention
Standard physical therapy
trampoline-based stretch-shortening cycle exercises
Sponsored by
Qassim University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Down Syndrome

Eligibility Criteria

7 Years - 9 Years (Child)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • King Khalid Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

standard physical therapy

trampoline-based stretch-shortening cycle exercises

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Grade of Muscle strength by hand-held dynamometer
A calibrated hand-held dynamometer (Micro FET2, Hoggan Health Technologies Inc., UT, USA) was used
Grade of Muscle strength by hand-held dynamometer
A calibrated hand-held dynamometer (Micro FET2, Hoggan Health Technologies Inc., UT, USA) was used

Secondary Outcome Measures

Postural control index by Balance Biodex System
Postural stability indices were assessed through the Balance Biodex System (Biodex Medical Systems, Shirley, NY),
Postural control index by Balance Biodex System
Postural stability indices were assessed through the Balance Biodex System (Biodex Medical Systems, Shirley, NY),

Full Information

First Posted
July 14, 2021
Last Updated
September 8, 2021
Sponsor
Qassim University
Collaborators
Cairo University, Prince Sattam Bin Abdulaziz University
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1. Study Identification

Unique Protocol Identification Number
NCT04966403
Brief Title
Effects of Stretch-shortening Cycle Exercises Postural Control in Down Syndrome
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
Study Type
Interventional

2. Study Status

Record Verification Date
September 2021
Overall Recruitment Status
Completed
Study Start Date
December 1, 2018 (Actual)
Primary Completion Date
August 20, 2019 (Actual)
Study Completion Date
June 5, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Qassim University
Collaborators
Cairo University, Prince Sattam Bin Abdulaziz University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Down Syndrome

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
32 (Actual)

8. Arms, Groups, and Interventions

Arm Title
standard physical therapy
Arm Type
Experimental
Arm Description
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.
Arm Title
trampoline-based stretch-shortening cycle exercises
Arm Type
Experimental
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Standard physical therapy
Other Intervention Name(s)
physical fitness
Intervention Description
building strength, enhancing developmental skills, boosting balance, coordination, and postural control
Intervention Type
Other
Intervention Name(s)
trampoline-based stretch-shortening cycle exercises
Other Intervention Name(s)
postural control
Intervention Description
muscle strength
Primary Outcome Measure Information:
Title
Grade of Muscle strength by hand-held dynamometer
Description
A calibrated hand-held dynamometer (Micro FET2, Hoggan Health Technologies Inc., UT, USA) was used
Time Frame
at baseline
Title
Grade of Muscle strength by hand-held dynamometer
Description
A calibrated hand-held dynamometer (Micro FET2, Hoggan Health Technologies Inc., UT, USA) was used
Time Frame
after 12 weeks
Secondary Outcome Measure Information:
Title
Postural control index by Balance Biodex System
Description
Postural stability indices were assessed through the Balance Biodex System (Biodex Medical Systems, Shirley, NY),
Time Frame
at baseline
Title
Postural control index by Balance Biodex System
Description
Postural stability indices were assessed through the Balance Biodex System (Biodex Medical Systems, Shirley, NY),
Time Frame
after 12 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
7 Years
Maximum Age & Unit of Time
9 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Alshimaa Azab, PhD
Organizational Affiliation
Cairo University
Official's Role
Study Director
Facility Information:
Facility Name
King Khalid Hospital
City
Al-Kharj
State/Province
Riyadh
Country
Saudi Arabia

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing 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.
Citations:
PubMed Identifier
31301057
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.
Results Reference
background
PubMed Identifier
27512557
Citation
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.
Results Reference
result
PubMed Identifier
20673078
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.
Results Reference
result

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Effects of Stretch-shortening Cycle Exercises Postural Control in Down Syndrome

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