- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05969808
Effects of Adapted Physical Activities on Visual Motor Integration in Children With Developmental Delay
Developmental delay occurs when a child does not achieve developmental milestones in comparison to peers of the same age range. Children and adolescents with developmental delay often experience participation restrictions. Visual motor integration (VMI) is the ability of the child's hands and eyes to work together to guide their movements. Visual motor integration is a broad term encompasses cognitive as well as manual domains. This study will focused on the Manual Dexterity and intra-limb coordination (VMI). And it will evaluate the effects of adaptive physical activity on Visual Motor Integration.
Adaptive physical activities (APAs) are exercises and games that have been specially designed to fulfil the unique needs and skills of special needs or developmental delays.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Punjab
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Lahore, Punjab, Pakistan, 54000
- Riphah International University
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Age group 3-6 (both Gender Male & Female) (39)
- Gross Motor Function Classification System, Level I
- & II (45)
- Manual Ability Classification System (MACS) levels
- 1-3 (46)
- Pre assessed Developmental delayed.
Exclusion Criteria:
- Visually impaired Child
- Children with co-morbidities such as Epilepsy, Hydrocephalus
- Fractures, contractures or conflicting concurrent treatment impacting motor Functioning
- Children with significant cognitive impairments.
- Children who have received specific interventions targeting Visual motor integration, manual dexterity or intra-limb coordination
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: control group
The control group will participate in regular activities and routines typically provided to children with developmental delays. These activities may include general playtime, basic gross motor activities, and free play with toys for 3 times a week for 45mins for 12 weeks. The control group will not receive any specific intervention targeted at improving visual motor integration, manual dexterity, or intra-limb coordination. Experimental group |
These activities included were warm-up activities, general playtime, basic gross motor activities, and free play with toys three times a week for 45 minutes for a period of 12 weeks.
Other Names:
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Active Comparator: experimental group
The Experimental group will receive the baseline treatment as Control group.
Adaptive Physical Activities will perform for to improve Visual Motor Integration 3 times a week for 45mins for 12 weeks.
Pre and post assessment will be performed by using box and boll test, box and block test, Discrete Vertical Finger Tapping Test (DVFTT), discrete horizontal finger tapping test and discrete vertical tapping test with ball.
|
The experimental group's intervention plan had the following 12 elements .
Each of which was completed for 10 minutes with two-minute breaks.
Warm-up activities, puzzles and manipulatives, e.g., interlocking blocks or shape sorting toys, Balloon Badminton, Obstacle course (crawl in Tunnel ), Peg board play, Tactile sensory bin exploration filled with sand, Ball roll and catch, Tracing shapes, Play dough and clay activities, Cutting and pasting.
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Box and Block Test (BBT)
Time Frame: 12 weeks
|
A frequently used assessment test, the Box and Block Test, measure manual dexterity and functional ability, mainly in those with upper limb disabilities.
This test measures the capacity to handle items and carry out tasks that call for fine motor abilities(47).
150 tiny wood cubic blocks (1-inch) plus a box with two compartments separated by a wooden wall make up the BBT.
2.5 cm wooden block on each side and a wooden box (53.7 x 25.4 cm) separated into two compartments by a wall 15.2 cm high were the materials used to evaluate the BB test.
The BBT entails moving as many little blocks as possible, one at a time, from the compartment on the tested side to the other with the same hand, being careful to cross over the gap.
The number of blocks that are correctly shifted in 60 seconds is used to calculate the score
|
12 weeks
|
|
Box and ball test ( BBT)
Time Frame: 12 weeks
|
The BBLT followed the same procedure as the BBTs.
The sole modification was that the BBLT evaluated the quantity of boccia balls rather than blocks.
Due to the size of the compartments, only six balls could fit inside at once.
It will be necessary to have two researchers, one at each end of the table.
|
12 weeks
|
|
discrete horizontal finger tapping test (DHFTT)
Time Frame: 12 weeks
|
This test used to measure the intra-limb coordination of upper limb.Participants will sit on their chairs and will be placed parallel to a table, at 10 cm from the edge of the tapping plates.
The table will be adjusted so that the bottom of the table will be aligned with the players' hips (greater trochanter), and the shoulders of the players' throwing arms with the plate A (start position).
Participants will asked to place their non-throwing arm across their chest and keep their throwing hand closed with the index finger extended To complete the test, participants will need to complete 10 tapping cycles, reporting their performance as the average score of the 10 tapping cycles.
A cycle was composed of the participants releasing from plate A to hit the plate B (finish position) as fast as possible.
The plates were displaced horizontally, and the distance between both plates' centers was 30 cm.
The metal plates were 30 cm long by 20 cm wide.
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12 weeks
|
|
Discrete vertical tapping test with ball
Time Frame: 12 weeks
|
this test used to measure the intra-limb coordination.
The plates will be arranged vertically in an "L" shape (90°), where plate A will be kept on horizontal but plate B will be placed on the vertical edge .The distance between both plates' centers will be 30 cm, like in the DHFTT, and the two tests will use the same protocol.
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12 weeks
|
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continuous vertical tapping test with ball
Time Frame: 12 weeks
|
this test used to measure the intra-limb coordination of upper limb.
Participants will perform a continuous movement consisting of grasping the ball and hitting plates A and B alternatively as fast as possible within 1 min.
Ball contact could be made on any part of the plates.
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12 weeks
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Laraib Batool, MS, Riphah International University
Publications and helpful links
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
Keywords
Other Study ID Numbers
- REC/ RCR & AHS/23/0726
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
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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