Effects of Maze Activities in Down's Syndrome

Effects on Maze Activities on Mobility in Children With Down's Syndrome

Down's Syndrome is due to the chromosomal disorder in 47 chromosomes instead of 46, socalled as Trisomy 21. The syndrome has several clinical symptoms including Cardiovascular,neurological, orthopedic, hormonal, cognitive and visual perceptual impairments. These childrenhave Developmental Delay. Children have hypermobility of joints, hypotonicity or ligamentous laxity, light to moderate obesity, due to underdeveloped respiratory and cardiovascular systemandshortstaturewhichleadtodecreaseinfunctionalambulation.Due to the low level of physical fitness, theseindividuals shows limitation in performing the functional tasks of daily living. The fundamental motor skill is Walking that facilitates the child to interact with the environment and helps indeveloping, social, motor and cognitive skills. Due to their delayed milestones and due to the irintellectual disability, environmental exposure is limited which hampers this fundamental skill.Hence it is necessary to asses the functional ambulation in these children.

This is a Randomized Controlled Trial that will be conducted in Rising Sun Institute Of Special Children. 26 participants will be allocated randomly into 2 groups Group A will receive the conventional interventions of Down's Syndrome but the group B will receive the mobility training with Standardized Walking Obstacle Course (SWOC). Tool used for this research will be a Standardized Walking Obstacle Course (SWOC) (that is used to measure stability and speed during gait in terms of time, number of steps, number of stumbles and number of steps off the path for each participant) and Timed up and go test (Valid for the functional mobility assessment of the children with DS). The data will be analyzed by SPSS version 21

Study Overview

• Status: Completed
• Conditions: Down Syndrome
• Intervention / Treatment: Other: Standardized Walking Obstacle Course (SWOC); Other: Conventional Gait Training

Detailed Description

This study will be a randomized control trail used to compare the Effects of Maze Activities on Mobility in Children With Down's Syndrome. Subjects with Down's syndrome meeting the predetermined inclusion and exclusion criteria will be divided into two groups using simple random sampling technique. Assessment will be done by using time up and go test and Standardized Walking Obstacle Course (SWOC). Subjects in group A will receive the conventional intervention of gait training and Group B will receive the training on Standardized walking obstacle course.

• Study Type: Interventional
• Enrollment (Actual): 26
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Pakistan
  • Punjab
    • Lahore, Punjab, Pakistan, 54000
      • Riphah International University Lahore

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• •Age 6 to 12 years of downs's syndrome children

  • Ambulatory Child who can walk without any assistive device(6)
  • Should follow commands and can perform 30 sec walk test.(6)

Exclusion Criteria:

• •Any congenital Cardiac Anomaly

  • Visual and Hearing Deficits
  • Any surgical intervention for the last 6 months

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Group A; The Group A (experimental group) will receive the treatment with Standardized walking obstacle course (SWOC).	Other: Standardized Walking Obstacle Course (SWOC); The Standardized Walking Obstacle Course (SWOC) is a test that allows interaction of a child with environmental demands and obstructions while examining differences in functional ambulation performances. The Group A (experimental group) will receive the treatment with Standardized walking obstacle course (SWOC), the group of 13 participants will receive the treatment. This group will receive therapy session for 45 min, thrice a week for 6 weeks, total sessions will be 18. 45 minutes session time will be divided into 15 min warm up period, 25 minutes of SWOC training and 5 minutes of cool down period.
Active Comparator: Group B; The Group B (Control group) will receive the treatment with conventional Gait training.	Other: Conventional Gait Training; Conventional gait training protocol including walking on a treadmill, parallel bar walk, seated marching. The Group B (Control group) will receive the treatment with conventional Gait training, the group of 13 participants will receive the treatment. This group will receive therapy session for 45 min, thrice a week for 6 weeks, total sessions will be 18. 45 minutes session time will be divided into 15 min warm up period, 25 minutes of Conventional gait training and 5 minutes of cool down period.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Timed up and Go Test (TUG)	Time up and go test is used to assess the balance and stability of a children with different abilities. It involves timing how long it takes for a child to stand up from a chair, walk a short distance, turn around, walk back, and sit down while turning 180 degree. Interpretation: < 10 seconds = normal, < 20 seconds = good mobility, can go out alone, mobile without a gait aid. < 30 seconds = problems, cannot go outside alone, requires a gait aid. A score of more than or equal to fourteen seconds has been shown to indicate high risk of falls.	6 weeks
Standardized Walking Obstacle Course (SWOC)	It is used to measure stability and speed during gait in terms of time, number of steps, number of stumbles and number of steps off the path.Standardized walking obstacle course (SWOC) It is used to measure stability and speed during gait in terms of time, No of steps, No of stumbles, No of step off the path It is used to measure stability and speed during gait in terms of time, number of steps, number of stumbles and number of steps off the path. It was assessed under three conditions such as walk with arms free, walk with tray and walk with sunglasses.	6 weeks

Collaborators and Investigators

• Sponsor: Riphah International University
• Investigators: Principal Investigator: Fibha Tariq, MS*, Riphah International University Lahore

Publications and helpful links

General Publications

• Kott KM, Held S, Franjoine MR. Reference data for performances on the standardized walking obstacle course in children developing typically. Gait Posture. 2016 Sep;49:398-401. doi: 10.1016/j.gaitpost.2016.08.001. Epub 2016 Aug 2.

Study record dates

Study Major Dates

• Study Start (Actual): December 5, 2023
• Primary Completion (Actual): February 5, 2024
• Study Completion (Actual): February 10, 2024

Study Registration Dates

• First Submitted: December 26, 2023
• First Submitted That Met QC Criteria: January 28, 2024
• First Posted (Actual): January 31, 2024

Study Record Updates

• Last Update Posted (Actual): June 13, 2024
• Last Update Submitted That Met QC Criteria: June 11, 2024
• Last Verified: June 1, 2024

More Information

Terms related to this study

• Keywords: Mobility; Down's Syndrome; Standardized Walking obstacle course (SWOC).
• Additional Relevant MeSH Terms: Pathologic Processes; Nervous System Diseases; Neurologic Manifestations; Neurobehavioral Manifestations; Disease; Congenital Abnormalities; Genetic Diseases, Inborn; Intellectual Disability; Abnormalities, Multiple; Chromosome Disorders; Syndrome; Down Syndrome
• Other Study ID Numbers: REC/RCR & AHS/23/0747

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