Skip to main content
OpenTrials
Recruiting

NCT Number: NCT07484464

Effects of the Otago Exercise Program on Balance, Endurance, and Motor Coordination in Children With Down Syndrome

The study will use a quasi-experimental design conducted over ten months in pediatric physiotherapy departments of tertiary care hospitals and special education schools. It will include 30 children aged 6-14 years with mild to moderate intellectual disability, selected after eligibility screening and guardian consent. Outcomes will be assessed using BOT-2, Berg Balance Scale, MMSE-C, and Six-Minute Walk Test to measure motor skills, balance, cognition, and endurance. Ethical approval will be obtained from the Research Ethical Committee of Riphah International University, Lahore, and data will be analyzed using SPSS version 26.0.

Recruiting

Interested in participating?

Request Info

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

8 year–14 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

About this study

Children with Down syndrome (DS) commonly face challenges such as reduced muscle tone, joint instability, and impaired coordination, all of which can impact their balance, mobility, and physical independence. While Otago exercises have proven effective in enhancing balance and coordination in older adults and adults with Down syndrome, their application in children with DS remains limited and underexplored.

The study will employ a quasi-experimental design. Data will be collected from the pediatric physiotherapy departments of tertiary care hospitals and special education schools. The duration of the study will be ten months following the approval of the research synopsis. A total of 30 children, aged between 6 and 14 years and diagnosed with mild to moderate intellectual disability, will be recruited. All referred participants will undergo screening to assess their eligibility based on predefined inclusion criteria. Informed consent will be obtained from the guardians of participants who meet the eligibility requirements prior to their enrollment in the study. Outcome measures will include the Bruininks-Oseretsky Test of Motor Proficiency, Second Edition (BOT-2), the Berg Balance Scale (BBS), and Mini-Mental State Examination for Children (MMSE-C), and the Six-Minute Walk Test (6MWT) to assess endurance capacity. The research synopsis will be submitted to the Research Ethical Committee of Riphah International University, Lahore, for ethical approval. Data will be analyzed using SPSS version 26.0

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • • Clinically diagnosed with Trisomy 21.
  • Aged between 8-14 years.(29)
  • Able to follow basic verbal instructions.
  • Ambulatory with or without assistive devices

Exclusion criteria

  • • Severe visual or auditory impairments.
  • Patient with moderate to severe cognitive impairments. (29)
  • Co-morbid neurological conditions (e.g., uncontrolled seizures, cerebral palsy).
  • Cardiac contraindications to moderate physical activity

Treatment and study plan

otago exercises

Other
  • WarmUp (510 mins) Marching on the spot Gentle arm swings Neck, shoulder, ankle movements
  • Strength Exercises (3 times/week using ankle weights):

Knee Extensions (seated leg straightening) Knee Flexions (standing leg curls) Hip Abductions (leg lifts to the side) Hip Extensions (leg lifts backward) Calf Raises (rise onto toes, holding support) Toe Raises (lift toes while heels remain on ground)

  • Balance Exercises (at least 3 times/week):

Heel to Toe Stand One Leg Stand Sit to Stand (from a chair, arms crossed) Turning Around (slow 360 degree turns) Backwards Walking Walking and Turning Head Sideways Walking Stair Climbing

  • Walking Plan:

At least 30 minutes of walking, twice weekly

  • Progression:

Gradually increase intensity, duration, repetitions

  • Duration:

Typical duration 8 weeks

Primary outcomes

  1. Bruininks-Oseretsky Test of Motor Proficiency

    Time frame: Baseline, 8 weeks

    The BOT-2 balance subtest evaluates motor control required for maintaining posture during standing, walking, and functional activities. It assesses balance through tasks measuring body stability, movement and stopping ability, and reliance on visual cues, including standing and walking under different conditions. Participants perform multiple tasks with two attempts allowed, and the best performance is recorded for scoring.

  2. Berg Balance Scale

    Time frame: Baseline, 8 weeks

    The Berg balance scale is a clinical assessment of functional balance. It consists of 14 functional tasks of increasing difficulty, and each is scored on a scale ranging from 0 to 4 (task is performed independently = 4; unable to complete the task = 0). The maximum possible score is 56 which indicates no identifiable balance difficulties

  3. Mini Mental State Examination (MMSE)

    Time frame: Baseline, 8 weeks

    This tool is used for cognitive assessment. The MMSE remains one of the most widely applied instruments for screening cognitive impairment, particularly in dementia, Alzheimer's disease, stroke, and general geriatric assessments.

  4. Six-Minute-Walk-Test (6MWT)

    Time frame: Baseline, 8 weeks

    The Six-Minute Walk Test (6MWT) is a simple, low-cost, and reliable tool used to assess functional exercise capacity and endurance, especially in individuals with moderate impairments. It measures the distance a participant can walk in six minutes under standardized conditions while monitoring vital signs and symptoms.

Study contacts

Contact information is provided by the study sponsor or research team.

IMRAN AMJAD, PhD

CONTACT

[email protected]

9233224390125

MUHAMMAD ASIF JAVED, MS-PT

CONTACT

[email protected]

923224209422

Sponsors and collaborators

Lead sponsor

Riphah International University

Other

Registry information

Official study title

Effects of OTAGO Exercise Program On Balance, Endurance And Motor Coordination In Children With Down Syndrome

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Mar 20, 2026
Registry last updated
Mar 20, 2026

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.

Related clinical trials

Published trials that share one or more normalized conditions with this study.