Clinical trial NCT06234644: Effects of Maze Activities in Down's Syndrome
Official title: Effects on Maze Activities on Mobility in Children With Down's Syndrome
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Down Syndrome
Keywords: Down's Syndrome
Mobility
Standardized Walking obstacle course (SWOC).
Lead sponsor: Riphah International University
Sponsor class: OTHER
First posted: 2024-01-31
Enrollment: 26
Sex: ALL
Minimum age (years): 6
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

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.

Eligibility criteria: 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

Primary outcomes:
measure: Timed up and Go Test (TUG)
timeFrame: 6 weeks
measure: Standardized Walking Obstacle Course (SWOC)
timeFrame: 6 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Lahore
country: Pakistan
facility: Riphah international university lahore
state: Punjab
Study officials:
affiliation: Riphah international university lahore
name: Fibha Tariq, MS*
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.