- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04315220
Corestability Training in Overweight Children
Effectiveness of Core Stability Training in Improving Postural Stability and Foot Pressure Distribution in Overweight Children: A Randomized Controlled Trial
A total of 52 overweight children aged between eight and sixteen years will be recruited by criterion based purposive sampling to participate in the two groups pretest post test randomized clinical study. Random allocation of the eligible subjects for treatment will be done by the block randomization method with matrix of thirteen rows and four columns (13x4). The subject will be allotted to the group randomly, based on the chit selected by the person other the primary researcher.Once the block is filled, the next row block will be opened. Thus equal distribution of overweight children in the each group will be ensured.
Group A will be receiving actual core stability training (Level 1 - Mat exercises and Level 2 - Swiss Ball exercises) for 6 weeks with a frequency of three sessions per week.Group B will receive no training. Each session will last for 30 minutes of duration. The static and dynamic balance, foot pressure distribution and core strength will be assessed at the baseline and at the end of the treatment sessions.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Haryana
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Ambala, Haryana, India, 133207
- Kanu Goyal
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Children of age 8- 16 years old.
- Both Boys and Girls.
- Child with BMI-for-age percentile growth between 85th to less than 95th percentile.
Exclusion Criteria:
- Uncooperative participants.
- Upper or lower limb fracture or injury in recent 6 months.
- Any musculoskeletal or neurological disorder affecting core strength and balance.
- Refuse to participate because not able to understand the researcher instructions.
- Unable to attend the whole sessions during the research period.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Experimental group (Core stability training (CST))
Core stability training (CST) consists of two levels: level 1- Mat exercises (includes abdominal muscle contraction, bridging,cat stretch,single leg circle and superman) and level 2- Swiss ball exercises (includes abdominal muscle contraction, bridging and squatting by using therapy ball). There will be three sets of 15 repetitions of each exercises. The first set will consist of 10 seconds hold period, follow by 12 seconds hold in second set and 15 seconds hold in third set respectively. The entire session will last for approximately 30 minutes. |
Level -1: Mat exercises Abdominal muscle contraction,bridging,cat stretch,single limb circle and superman.: Level- 2: Swiss Ball Exercises Abdominal contraction,bridging and squats. |
Active Comparator: Control group
Will not receive any kind of training.
|
No Intervention
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Foot pressure distribution
Time Frame: change from baseline and six weeks
|
All overweight children will be asked to walk barefoot along a 5-.metre walkway using Harris mat pressure distribution platform which will be placed on a firm, level surface, in the centre of walkway.
Children will be ensured to step on the Harris mat without pause, first with one foot and then repeat the same procedure with the other foot at constant speed.
Foot markings then analyzed by using
|
change from baseline and six weeks
|
Single limb stance
Time Frame: change from baseline and six weeks
|
The children will be instructed to stand on the dominant leg with non dominant leg flexed to 90 degree, and maintain the position.
The test will be performed first with eyes open and then with the eyes closed.
The time for which participant will be able to maintain balance will be recorded
|
change from baseline and six weeks
|
Y- reach set
Time Frame: change from baseline and six weeks
|
The participant will stand on one foot in the center of the Y with the most distal aspect of the toes just behind the starting line.
While maintaining single-leg stance, the balance will be tested in the anterior, postero-medial and postero-lateral direction with reach foot.
The reach distance in all the three directions will be noted.
|
change from baseline and six weeks
|
Core Strength
Time Frame: change from baseline and six weeks
|
The core strength will be measured with the Chattanooga Pressure Biofeedback Unit.
The device will be placed under the lumbar spine in crook lying and inflated to a baseline of 40 mmHg.
The participants will be instructed to perform drawing-in maneuver on the verbal instructions, maintain it for 10 sec.
The change in pressure will be noted
|
change from baseline and six weeks
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Kanu Goyal, BPT, DOMTP, Maharishi Markandeshwar Institute of physiotherapy and Rehabilitation
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- MMDU/2020
- U1111-1249-8305 (Other Identifier: Universal Trial Number (UTN) by WHO ICTRP)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Time Frame
IPD Sharing Access Criteria
IPD Sharing Supporting Information Type
- Study Protocol
- Statistical Analysis Plan (SAP)
- Informed Consent Form (ICF)
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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