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

March 16, 2026 updated by: Riphah International University

Effects of 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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

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

Study Type

Interventional

Enrollment (Estimated)

30

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: OTAGO Exercises
Researcher give OTAGO exercises in one group
Other: OTAGO Exercises
  1. WarmUp (510 mins) Marching on the spot Gentle arm swings Neck, shoulder, ankle movements

  2. 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)

  3. 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

  4. Walking Plan:

    At least 30 minutes of walking, twice weekly

  5. Progression:

    Gradually increase intensity, duration, repetitions

  6. Duration:

Typical duration 8 weeks

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Baseline, 8 weeks
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
Baseline, 8 weeks
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.
Baseline, 8 weeks
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.
Baseline, 8 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Riphah International University

Investigators

  • Principal Investigator: FATIMA TARIQ, MS-PT, Riphah International University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 2, 2026

Primary Completion (Estimated)

July 30, 2026

Study Completion (Estimated)

August 30, 2026

Study Registration Dates

First Submitted

March 16, 2026

First Submitted That Met QC Criteria

March 16, 2026

First Posted (Actual)

March 20, 2026

Study Record Updates

Last Update Posted (Actual)

March 20, 2026

Last Update Submitted That Met QC Criteria

March 16, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • REC/RCR&AHS/FATIMATARIQ

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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