Action Observation Therapy on Balance in Children With Down Syndrome

NCT06198075 | Completed

• 1 other identifier: REC/RCR&AHS/23/0742
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

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.

Conditions

Down Syndrome

Keywords

Action Observation; Balance; Down syndrome; Rehabilitation

Outcome Measures

Primary Outcomes (2)

• 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

Study Arms (2)

Control group

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

Other: Control Group

Experimental group

EXPERIMENTAL

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

Interventions

Control Group 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

Control group

Experimental Group 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.

Experimental group

Eligibility Criteria

• Age: 6 Years - 12 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Riphah International University: lead

Study Sites (1)

Riphah International University

Lahore, Punjab Province, Pakistan

Location

Related Publications (1)

• 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.

  PMID: 32570855 BACKGROUND

MeSH Terms

Conditions

Down Syndrome

Interventions

Control Groups

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

Intervention Hierarchy (Ancestors)

Epidemiologic Research Design; Epidemiologic Methods; Investigative Techniques; Research Design; Methods

Study Officials

• Zainab Jabir, MS

  Riphah International University

  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

Model Details: The study will be randomized controlled trial used to evaluate the effectiveness of action observation therapy on balance in children with down syndrome. Subjects with down syndrome meeting the inclusion and exclusion criteria will be divided into two groups using non-probability sampling technique.

Study Record Dates

• First Submitted: December 26, 2023
• First Posted: January 10, 2024
• Study Start: December 1, 2023
• Primary Completion: February 5, 2024
• Study Completion: February 5, 2024
• Last Updated: June 13, 2024

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will not share

Locations

PA (1)