Relationship Between BMI, Physical Fitness and Motor Skills in Children With Down's Syndrome
1 other identifier
observational
169
1 country
1
Brief Summary
Down syndrome is a congenital condition which includes physical mental, and functional abnormalities. It arises from defect involving chromosome 21, usually an extra copy (trisomy 21). Purpose of this study will determine the relationship between BMI, physical fitness and motor skills in youth with down syndrome
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started May 2023
Shorter than P25 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 23, 2023
CompletedFirst Submitted
Initial submission to the registry
June 6, 2023
CompletedFirst Posted
Study publicly available on registry
June 15, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 31, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
September 15, 2023
CompletedNovember 13, 2023
November 1, 2023
3 months
June 6, 2023
November 10, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (21)
Time up and go (TUG)
The participant will sit in a chair keeping the back straight in contact with the backrest, the feet resting on the floor and the hands on the thighs. At the "go" signal, the subject gets up from the chair, moves as fast as he can to the line fifteen black that is located 3 m from the front legs of the chair, turns and returns to the sitting position traveling a total of 6 m (3 out and 3 back). The timer starts when the subject starts to move and stops when the back touches the back when sitting down.
2 months
The Deep Trunk Flexibility test (DTF)
The initial position of the subjects was standing with their legs separated at the width of the waist. The subjects flexed their trunk and their knees and put their arms downwards and behind their legs to slide the cursor of the millimeter bar with their fingertips of both hands. A measurement bench (10 × 10 × 55 cm, height, width and length, respectively) was used for the evaluation. Two tries were done, and the best mark was chosen, following the indications of Valdivia et al. with children and adolescents
2 months
The Hand Grip test (HG).
The subject is placed in a standing position with the dynamometer in his dominant hand. The dynamometer grip is adjusted to the size of the hand to have the second phalanx of the index finger approximately at a right angle. Arms slightly separated from the body. It is not allowed to lean the trunk to any side or bend the elbows. The subject squeezes the dynamometer firmly and gradually, rapidly increasing to maximum force muscles, especially of the finger flexors. The participants were asked to push as hard as possible after the command 'and go'. There were two tries with each hand, establishing 10 s of rest between them
2 months
Timed Stand Test (TST).
The subject must sit on the chair so that his knees form an angle of 90º. To do this, it will be necessary to adjust the height of the chair for each participant. The subject sits in the chair, which will be leaning against a wall, and is asked to perform ten squats as quickly as possible without using the arms to propel himself. The arms should remain crossed in front of the chest and straighten the knees with each repetition. The timer starts when the movement is started and stops when the subject returns to a sitting position after the tenth squat. Rubber treads may be used to facilitate foot placement for the subject
2 months
The 30-s Sit-Up (SUP).
The subject must be lying in a supine position with the legs resting on the floor. The maximum number of push-ups should be performed for 30 seconds. The correct execution (what is considered a correct complete repetition) is established when the participant raises the scapulae from the ground, keeping the arms stretched out in front and resting them again. As a reference, it was indicated that the subjects touch the patella (put the evaluator's arm in that area to avoid confusion), which in this position forces the scapular area to come off the ground. It is recommended that the investigator hold the participant's legs to prevent any movement of her legs or feet
2 months
The 6-Min Walk Test (6MWT)
: Regarding the use of the clock, follow the manufacturer's instructions for its correct operation. The participant must try to cover the maximum distance possible in 6 minutes. Running is prohibited, so the subject can only walk fast. It is necessary that the research staff constantly motivate the participants
2 months
BMI (BMI = kg/m2)
To calculate the BMI, the weight (kg) is divided by the height (m2) difference is greater than 1cm/1kg, a third measurement will be taken. Subsequently, the average is made with the two closest measurements.
2 months
Waist Circumference
The subject will be standing, with the abdomen relaxed and the arms relaxed parallel to the trunk. The measurement should not be done on clothing, so the shirt should be removed or pulled up without you having to hold it. From this position, the examiner will encircle the subject's waist with the tape measure. The measurement will be made at the narrowest level, between the edge of the lower costal (10th rib) and the iliac crest, at the end of a normal expiration and without the tape pressing on the skin and with the participant's arms at their sides. If there is no obvious minimum waist, the measurement will be taken at the midpoint between the lower costal edge (10th rib) and the iliac crest.
2 months
ROM
The subject will be placed in a standing position with the legs separated at the width of the hips. The feet will be in line with the edge of the instrument, so that the heels are placed on the line at the 0 level of the scale, and they will not be able to move during the test. At the signal, the person must flex the trunk downwards and backwards, pushing the cursor of the millimeter bar with the middle fingers of both hands (which have passed between the legs) until they advance as far as possible. It is allowed to flex the knees
2 months
Run
Directions:Mark off two lines 50 feet apart. Instruct student to "run fast" from one line to the other. "Brief period where both feet are off the ground "Arms in opposition to legs, elbows bent. Foot placement near or on line (not flat footed). onsupport leg bent approximately 90 degrees (close to buttocks).
2 months
Gallop
Mark off two lines 30 feet apart. Tell student to gallop from one line to the other three times. Tell student to gallop leading with one foot and then the other. A step forward with the lead foot followed by a step with the trailing foot to a position adjacent to or behind the led foot. * "Brief period where both feet are off the ground. * "Arms bent and lifted to waist level.
2 months
Hop
DIRECTIONS: Ask the student to hop three times, first on one foot and then on the other. \*This criteria does not require the performance of the other three. Foot of nonsupport leg is bent and carried in back of the body. * "Nonsupport leg swings in pendular fashion to produce force. * "Arms bent at elbows and swing forward on take off. * "Able to hop on the right and left foot.\*
2 months
Leap
DIRECTIONS: Ask the student to leap. Tell the student to take large steps by leaping from one foot to the other. Take off on one foot and land on the opposite foot. * "A period where both feet are off the ground (longer than running). * "Forward reach with arm opposite the lead foot.
2 months
Horizontal Jump
DIRECTIONS: Mark off a starting line on the floor, mat, or carpet. Have the student start behind the line. Tell the student to "jump far." * "Preparatory movement includes flexion of both knees with arms extended behind the body. * "Arms extend forcefully forward and upward, reaching full extension above head. * "Take off and land on both feet simultaneously. * "Arms are brought downward during landing.
2 months
Skip
DIRECTIONS: Mark off two lines 30 feet apart. Tell the student to skip from one line to the other three times. * "A rhythmical repetition of the step-hop on alternate feet. * "Foot of nonsupport leg carried near surface during hop phase. * "Arms alternately moving in opposition to legs at about waist level
2 months
Slide
DIRECTIONS: Mark off two lines 30 feet apart. Tell the student to slide from one line to the other line three times facing the same direction. "Body turned sideways to desired direction of travel. * "A step sideways followed by a slide of the trailing foot to a point next to the lead foot. * "A short period where both feet are off the floor. * "Able to slide to the right and to the left side.
2 months
Two Hand strike
DIRECTIONS: Toss the ball softly to the student at bout waist level. Tell the student to hit the ball"hard." Count only those tosses that are between the student's waist and shoulders. * "Dominant hand grips bat above nondominant hand. * "Nondominant side of body faces the tosser (feet parallel). * "Hip and spine rotation. * "Weight is transferred by stepping with front foot.
2 months
Stationary Bounce
DIRECTIONS: Tell the student to bounce the ball three times using one hand. Make sure the ball is not underinflated. Repeat three separate trials. * "Contact ball with one hand at about hip height. * "Pushes ball with fingers (not a slap). * "Ball contacts floor in front of (or to the outside of) foot on the side of the hand being used.
2 months
Catch
DIRECTIONS: Mark off two lines 15 feet apart. Student stands on one line and the tosser on the other. Toss the ball underhand directly to student with a slight arc, saying "catch it with your hands." Only count those tosses that are between student's shoulders and waist. "Preparation phase where elbows are flexed and hands are in front of body. * "Arms extend in preparation for ball contact. * "Ball is caught and controlled by hands only. * "Elbows bend to absorb force
2 months
kick
DIRECTIONS: Mark off one line 30 feet away from a wall and one that is 20 feet from the wall. Place the ball on the line nearest the wall and tell the student to stand on the other line. Tell the student to kick the ball "hard" toward the wall. * "Rapid continuous approach to the ball. * "The trunk is inclined backward during ball contact. * "Forward swing of the arm opposite kicking leg. * "Follow-through by hopping on non-kicking foot.
2 months
Overhead Throw
DIRECTIONS: Tell the student to throw the ball "hard" at the wall. * "A downward arc of the throwing arm initiates the windup. * "Rotation of hip and shoulder to a point where the nondominant side faces an imaginary target. * "Weight is transferred by stepping with the foot * "Follow-through beyond ball release diagonally across body toward side opposite throwing arm.
2 months
Eligibility Criteria
DownsSyndrome
You may qualify if:
- Diagnosed with trisomy 21.
- Aged 5-15 years.
- Abel to follow a minimum of two-step instructions.
- The minimum motor ability of participants with DS is independent locomotion.
You may not qualify if:
- Medical condition that is contraindicated to moderate to vigorous physical activity such as cardiovascular problems.
- Orthopedic instability, including those associated with DS (e.g., Atlanto-axial instability).
- Behavioral issues that hindered instruction
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Riphah International University
Lahore, Punjab Province, Pakistan
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Mahnoor Bukhari, MS
Riphah International University
Study Design
- Study Type
- observational
- Observational Model
- OTHER
- Time Perspective
- CROSS SECTIONAL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 6, 2023
First Posted
June 15, 2023
Study Start
May 23, 2023
Primary Completion
August 31, 2023
Study Completion
September 15, 2023
Last Updated
November 13, 2023
Record last verified: 2023-11
Data Sharing
- IPD Sharing
- Will not share