Back to resultsEffects of Core Stability Exercises With and Without Treadmill Training on Balance in Children With Down Syndrome
Primary Purpose
Down Syndrome
Status
Recruiting
Phase
Not Applicable
Locations
Pakistan
Study Type
Interventional
Intervention
core stability exercises with treadmill
core stability exercise without treadmill
Sponsored by
About this trial
This is an interventional treatment trial for Down Syndrome focused on measuring core stability exercises, balance, treadmill
Eligibility Criteria
Inclusion Criteria:
- able to stand and walk independently
- able to understand and follow a verbal command
- cutoff score less than 6 or 7 in functional balance in indicated
Exclusion Criteria:
- patients have any neurological issue,
- Instability of atlantoaxial joint
- Vision and hearing loss
- History of fall
Sites / Locations
- International Therapy Services CenterRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
core stability exercise, treadmill
core stability exercises
Arm Description
core stability exercises and treadmill training
core stability exercises without treadmill training
Outcomes
Primary Outcome Measures
Berg balance scale
berg balance scale was used to measure the functional balance in children.
Secondary Outcome Measures
Reach test
reach test is used to measure the stability in children
Full Information
NCT ID
NCT05460910
First Posted
July 14, 2022
Last Updated
July 14, 2022
Sponsor
Riphah International University
1. Study Identification
Unique Protocol Identification Number
NCT05460910
Brief Title
Effects of Core Stability Exercises With and Without Treadmill Training on Balance in Children With Down Syndrome
Official Title
Effects of Core Stability Exercises With and Without Treadmill Training on Balance in Children With Down Syndrome
Study Type
Interventional
2. Study Status
Record Verification Date
July 2022
Overall Recruitment Status
Recruiting
Study Start Date
May 18, 2022 (Actual)
Primary Completion Date
October 1, 2022 (Anticipated)
Study Completion Date
November 15, 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Riphah International 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 find the effects of core stability exercises with and without treadmill training on balance in children with down syndrome
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Down Syndrome
Keywords
core stability exercises, balance, treadmill
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
24 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
core stability exercise, treadmill
Arm Type
Experimental
Arm Description
core stability exercises and treadmill training
Arm Title
core stability exercises
Arm Type
Experimental
Arm Description
core stability exercises without treadmill training
Intervention Type
Other
Intervention Name(s)
core stability exercises with treadmill
Intervention Description
swiss ball use patient is lying in supine position with 15 repitations and 3 sets.
Intervention Type
Other
Intervention Name(s)
core stability exercise without treadmill
Intervention Description
technique used to improve stability
Primary Outcome Measure Information:
Title
Berg balance scale
Description
berg balance scale was used to measure the functional balance in children.
Time Frame
8th week
Secondary Outcome Measure Information:
Title
Reach test
Description
reach test is used to measure the stability in children
Time Frame
8week
10. Eligibility
Sex
All
Minimum Age & Unit of Time
6 Years
Maximum Age & Unit of Time
10 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
able to stand and walk independently
able to understand and follow a verbal command
cutoff score less than 6 or 7 in functional balance in indicated
Exclusion Criteria:
patients have any neurological issue,
Instability of atlantoaxial joint
Vision and hearing loss
History of fall
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Imran Amjad, Phd
Phone
+923324390125
Email
imran.amjad@riphah.edu.pk
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Wajiha Shahid, PhD
Organizational Affiliation
Riphah International University
Official's Role
Principal Investigator
Facility Information:
Facility Name
International Therapy Services Center
City
Lahore
State/Province
Punjab
ZIP/Postal Code
40050
Country
Pakistan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
wajiha shahid, phd
Phone
03036088768
Email
wajiha.shahid@riphah.edu.pk
First Name & Middle Initial & Last Name & Degree
maryam akram, MS (PPT)
First Name & Middle Initial & Last Name & Degree
kaneez amna, MS(PPT)
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
30520448
Citation
Szafraniec R, Baranska J, Kuczynski M. Acute effects of core stability exercises on balance control. Acta Bioeng Biomech. 2018;20(4):145-151.
Results Reference
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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
Citation
Amini HA, Fazel Kalkhoran J, Salehi M, Jazini F. Effect of backward walking training on improves postural stability in children with down syndrome. International Journal of Pediatrics. 2016;4(7):2171-81.
Results Reference
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Effects of Core Stability Exercises With and Without Treadmill Training on Balance in Children With Down Syndrome
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