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Completed

NCT Number: NCT06198075

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.

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Key information

Conditions

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

Age range

6 year–12 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Riphah International University

Lahore, Punjab Province, Pakistan

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

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.

Primary outcomes

  1. Pediatric berg balance scale

    Time frame: 6 weeks

    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).

  2. Modified Timed up and go test

    Time frame: 6 weeks

    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).

Sponsors and collaborators

Lead sponsor

Riphah International University

Other

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Jan 10, 2024
Registry last updated
Jun 13, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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