Effects of Maze Activities in Down's Syndrome

NCT06234644 | Completed

• 1 other identifier: REC/RCR & AHS/23/0747
• Study Type: interventional
• Target: 26
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Down Syndrome

Keywords

Down's Syndrome; Mobility; Standardized Walking obstacle course (SWOC).

Outcome Measures

Primary Outcomes (2)

• 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

Study Arms (2)

Group A

ACTIVE COMPARATOR

The Group A (experimental group) will receive the treatment with Standardized walking obstacle course (SWOC).

Other: Standardized Walking Obstacle Course (SWOC)

Group B

ACTIVE COMPARATOR

The Group B (Control group) will receive the treatment with conventional Gait training.

Other: Conventional Gait Training

Interventions

Standardized Walking Obstacle Course (SWOC) OTHER

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.

Group A

Conventional Gait Training OTHER

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.

Group B

Eligibility Criteria

• Age: 6 Years - 12 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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)

You may not qualify if:

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

Sponsors & Collaborators

• Riphah International University: lead

Study Sites (1)

Riphah international university lahore

Lahore, Punjab Province, 54000, Pakistan

Location

Related Publications (1)

• 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.

  PMID: 27505143 BACKGROUND

MeSH Terms

Conditions

Down Syndrome

Condition Hierarchy (Ancestors)

Intellectual Disability; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Abnormalities, Multiple; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Chromosome Disorders; Genetic Diseases, Inborn

Study Officials

• Fibha Tariq, MS*

  Riphah international university lahore

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 26, 2023
• First Posted: January 31, 2024
• Study Start: December 5, 2023
• Primary Completion: February 5, 2024
• Study Completion: February 10, 2024
• Last Updated: June 13, 2024

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will not share

Locations

PA (1)