- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05271201
Exercise Intensity for Down Syndrome Children
February 26, 2022 updated by: Hatem Allam, Taif University
Effect of Exercise Intensity on Knee and Ankle Joints' Torque and Functional Mobility in Children With Down's Syndrome: a Randomized Controlled Trial
The current study aimed to determine the appropriate exercise intensity for the rehabilitation of children with down syndrome.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
Two groups of down syndrome children were recruited.
one group received mild-intensity treadmill training while the other received moderate-intensity treadmill training.
Eccentric knee extensors and ankle plantar flexors peak torques were assessed before and after the intervention.
Also, functional mobility was assessed for both groups before and after the intervention.
The within and between-subjects effect was used to analyze the obtained data before and after the intervention.
isokinetic dynamometer and the time up and go test were used for evaluation.
Study Type
Interventional
Enrollment (Actual)
34
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
-
-
Mecca
-
Ta'if, Mecca, Saudi Arabia, 2425
- College of Applied Medical Sciemces
-
-
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
8 years to 12 years (Child)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Male
Description
Inclusion Criteria:
- independent walking
- Intelligence quotient range from 40 to 70
- right dominant foot
- body mass index from 50 to 75
Exclusion Criteria:
- chronic diseases
- congenital anomalies
- involved in any competitive sport
- previous injury to the lower limb
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 Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: mild intensity group
Received mild intensity treadmill training according to Martti Karvonen's formula.
|
mild intensity treadmill training.
|
|
Experimental: moderate intensity group
Received moderate intensity treadmill training according to Martti Karvonen's formula.
|
moderate-intensity treadmill training
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
knee extensor peak torque
Time Frame: three months
|
eccentric normalized peak torque of the knee extensors of the dominant limb.
|
three months
|
|
ankle plantar fexors peak torque
Time Frame: three months
|
eccentric normalized peak torque of the ankle plantar flexors of the dominant limb.
|
three months
|
|
functional mobility
Time Frame: three months
|
the assessment of the time up and go test
|
three months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Hatem H Allam, ass. prof., Taif University
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 10, 2019
Primary Completion (Actual)
March 15, 2020
Study Completion (Actual)
March 27, 2020
Study Registration Dates
First Submitted
February 26, 2022
First Submitted That Met QC Criteria
February 26, 2022
First Posted (Actual)
March 8, 2022
Study Record Updates
Last Update Posted (Actual)
March 8, 2022
Last Update Submitted That Met QC Criteria
February 26, 2022
Last Verified
February 1, 2022
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 291
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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