Action Observation Therapy on Balance in Children With Down Syndrome

Effects of Action Observation Therapy on Balance in Children With Down Syndrome

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.

Study Overview

• Status: Completed
• Conditions: Down Syndrome
• Intervention / Treatment: Other: Control Group; Device: Experimental Group

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.

• Study Type: Interventional
• Enrollment (Actual): 32
• Phase: Not Applicable

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: Yes

Description

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

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
Other: 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	Other: 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
Experimental: 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.	Device: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pediatric berg balance scale	Pediatric balance scale is a modified version of berg balance scale that is used to assess functional balance skills in children. The scale consists of 14 items that are scored from 0 points (lowest function) to 4 points (highest function) with a maximum score of 56 points It has good reliability and validity with (ICC=0.997) (r=0.797, p <0.05).	6 weeks
Modified Timed up and go test	The timed UP & GO (TUG) test was developed by Podsiadlo and Richardson in 1991 that is used to assess dynamic balance during the performance of a task. This test measures in second the time required for an individual to stand up from a standard chair with armrest, walk 3m and turn around with reliability and validity of (ICC=0.98; p<0.01).	6 weeks

Collaborators and Investigators

• Sponsor: Riphah International University
• Investigators: Principal Investigator: Zainab Jabir, MS, Riphah International University

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): December 1, 2023
• Primary Completion (Actual): February 5, 2024
• Study Completion (Actual): February 5, 2024

Study Registration Dates

• First Submitted: December 26, 2023
• First Submitted That Met QC Criteria: December 26, 2023
• First Posted (Actual): January 10, 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: Rehabilitation; Balance; Down syndrome; Action Observation
• 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/23/0742

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