- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05460910
Effects of Core Stability Exercises With and Without Treadmill Training on Balance in Children With Down Syndrome
July 14, 2022 updated by: Riphah International University
To find the effects of core stability exercises with and without treadmill training on balance in children with down syndrome
Study Overview
Status
Recruiting
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Anticipated)
24
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
-
-
Punjab
-
Lahore, Punjab, Pakistan, 40050
- Recruiting
- International Therapy Services Center
-
Principal Investigator:
- maryam akram, MS (PPT)
-
Sub-Investigator:
- kaneez amna, MS(PPT)
-
-
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
6 years to 10 years (CHILD)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
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: DOUBLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
EXPERIMENTAL: core stability exercise, treadmill
core stability exercises and treadmill training
|
swiss ball use patient is lying in supine position with 15 repitations and 3 sets.
|
|
EXPERIMENTAL: core stability exercises
core stability exercises without treadmill training
|
technique used to improve stability
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Berg balance scale
Time Frame: 8th week
|
berg balance scale was used to measure the functional balance in children.
|
8th week
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Reach test
Time Frame: 8week
|
reach test is used to measure the stability in children
|
8week
|
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.
- Szafraniec R, Baranska J, Kuczynski M. Acute effects of core stability exercises on balance control. Acta Bioeng Biomech. 2018;20(4):145-151.
- 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.
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)
May 18, 2022
Primary Completion (ANTICIPATED)
October 1, 2022
Study Completion (ANTICIPATED)
November 15, 2022
Study Registration Dates
First Submitted
July 14, 2022
First Submitted That Met QC Criteria
July 14, 2022
First Posted (ACTUAL)
July 15, 2022
Study Record Updates
Last Update Posted (ACTUAL)
July 15, 2022
Last Update Submitted That Met QC Criteria
July 14, 2022
Last Verified
July 1, 2022
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- REC/RCR & AHS/22/0712
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
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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