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

NCT07484464 | Recruiting DMC

• 1 other identifier: REC/RCR&AHS/FATIMATARIQ
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Down Syndrome

Keywords

Balance,; Motor Coordination; Endurance; OTAGO Exercises

Outcome Measures

Primary Outcomes (4)

• Bruininks-Oseretsky Test of Motor Proficiency

  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

  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)

  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)

  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

Study Arms (1)

OTAGO Exercises

EXPERIMENTAL

Researcher give OTAGO exercises in one group

Other: OTAGO Exercises

Interventions

OTAGO Exercises OTHER

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

OTAGO Exercises

Eligibility Criteria

• Age: 8 Years - 14 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Riphah International University: lead

Study Sites (1)

Gulab Devi

Lahore, Punjab Province, 54000, Pakistan

RECRUITING

Related Publications (1)

• Thomas S, Mackintosh S, Halbert J. Does the 'Otago exercise programme' reduce mortality and falls in older adults?: a systematic review and meta-analysis. Age Ageing. 2010 Nov;39(6):681-7. doi: 10.1093/ageing/afq102. Epub 2010 Sep 4.

  PMID: 20817938 BACKGROUND

MeSH Terms

Conditions

Down Syndrome

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

Study Officials

• FATIMA TARIQ, MS-PT

  Riphah International University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

IMRAN AMJAD, PhD

CONTACT

9233224390125; imran.amjad@riphah.edu.pk

MUHAMMAD ASIF JAVED, MS-PT

CONTACT

923224209422; a.javed@riphah.edu.pk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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 Record Dates

• First Submitted: March 16, 2026
• First Posted: March 20, 2026
• Study Start: March 2, 2026
• Primary Completion (Estimated): July 30, 2026
• Study Completion (Estimated): August 30, 2026
• Last Updated: March 20, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

PA (1)