Action Observation Therapy on Balance in Children With Down Syndrome

NCT ID: NCT06198075

Last Updated: 2024-06-13

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 32 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-12-01
• Study Completion Date: 2024-02-05

Brief Summary

Down syndrome is a condition in which a child is born with an extra copy of their 21st chromosome hence its other name is trisomy 21. The hallmarks of Down syndrome are mental retardation, hypotonia and characteristic phenotype features. Balance is one of the major issue. Action observation therapy focus on the concept of balance improvement.

Detailed Description

The study will be randomized controlled trail used to evaluate the effectiveness of Action observation therapy on balance in children with down syndrome. subjects with down syndrome meeting the inclusion exclusion criteria will be divided into two groups using non-probability sampling technique. Assessment will be done using Pediatric balance scale(PBS) and Timed up and go test(TUG) . Control group will receive regular physical therapy with balance training and experimental group will receive regular physical therapy + Action observation therapy.

Conditions

Down Syndrome

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Control group

Subjects will receive 6 weeks of general physical therapy,3 times/week for 30 min each session. The exercise program will include lying to sitting position, moving in the sitting posture, sitting and standing up, posture training for learning a normal gait pattern, weight bearing and weight movement training in the straight posture, walking training on the flat floor and stair walking. Final assessment will be done after 6 weeks

Group Type: OTHER

Control Group

Intervention Type: OTHER

Subjects will receive 6 weeks of general physical therapy,3 times/week for 30 min each session. The exercise program will include lying to sitting position, moving in the sitting posture, sitting and standing up, posture training for learning a normal gait pattern, weight bearing and weight movement training in the straight posture, walking training on the flat floor and stair walking. Final assessment will be done after 6 weeks

Experimental group

Subjects will watch a video on a screen from 1 meter in front of their chairs while sitting comfortably with their arms resting but they were not allowed to physically follow the video or move. The model of the video motion observation exercises will perform by the therapist and the training video consist of 4 stages that varied by difficulty and the video of each step was watched for the entire week. The participants watched a video of a task presented by the therapist and after completing the assignment they will perform the steps if step will too difficult to perform retraining will be conducted. Final assessment will be done after 6 weeks.

Group Type: EXPERIMENTAL

Experimental Group

Intervention Type: DEVICE

Subjects will watch a video on a screen from 1 meter in front of their chairs while sitting comfortably with their arms resting but they were not allowed to physically follow the video or move. The model of the video motion observation exercises will perform by the therapist and the training video consist of 4 stages that varied by difficulty and the video of each step was watched for the entire week. The participants watched a video of a task presented by the therapist and after completing the assignment they will perform the steps if step will too difficult to perform retraining will be conducted.

Interventions

Control Group

Subjects will receive 6 weeks of general physical therapy,3 times/week for 30 min each session. The exercise program will include lying to sitting position, moving in the sitting posture, sitting and standing up, posture training for learning a normal gait pattern, weight bearing and weight movement training in the straight posture, walking training on the flat floor and stair walking. Final assessment will be done after 6 weeks

Intervention Type: OTHER

Experimental Group

Subjects will watch a video on a screen from 1 meter in front of their chairs while sitting comfortably with their arms resting but they were not allowed to physically follow the video or move. The model of the video motion observation exercises will perform by the therapist and the training video consist of 4 stages that varied by difficulty and the video of each step was watched for the entire week. The participants watched a video of a task presented by the therapist and after completing the assignment they will perform the steps if step will too difficult to perform retraining will be conducted.

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• Children with age group of 6-12
• Both male and female
• Body Mass Index (BMI) within normal range (57.1%)
• Absence of any psychiatric and physical illness at the time of participation

Exclusion Criteria

• Uncontrolled seizures
• Any kind of orthopedic condition
• Registered visually impaired
• Severe Atlanto Axial instability
• Unable or unwilling to understand and attempt the task

• Minimum Eligible Age: 6 Years
• Maximum Eligible Age: 12 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Riphah International University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Zainab Jabir, MS

Role: PRINCIPAL_INVESTIGATOR

Riphah International University

Locations

Riphah International University

Lahore, Punjab Province, Pakistan

Countries

Pakistan

References

Jeong YA, Lee BH. Effect of Action Observation Training on Spasticity, Gross Motor Function, and Balance in Children with Diplegia Cerebral Palsy. Children (Basel). 2020 Jun 18;7(6):64. doi: 10.3390/children7060064.

Reference Type: BACKGROUND

PMID: 32570855 (View on PubMed)

Other Identifiers

REC/RCR&AHS/23/0742

Identifier Type: -

Identifier Source: org_study_id