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

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

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07484464
Enrollment
30
Registered
2026-03-20
Start date
2026-03-02
Completion date
2026-08-30
Last updated
2026-03-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Down Syndrome

Keywords

Balance,, Motor Coordination, Endurance, OTAGO Exercises

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.

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

Interventions

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

Sponsors

Riphah International University
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Intervention model description

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.

Eligibility

Sex/Gender
ALL
Age
8 Years to 14 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Bruininks-Oseretsky Test of Motor ProficiencyBaseline, 8 weeksThe 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.
Berg Balance ScaleBaseline, 8 weeksThe 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
Mini Mental State Examination (MMSE)Baseline, 8 weeksThis 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.
Six-Minute-Walk-Test (6MWT)Baseline, 8 weeksThe 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.

Countries

Pakistan

Contacts

CONTACTIMRAN AMJAD, PhD
imran.amjad@riphah.edu.pk9233224390125
CONTACTMUHAMMAD ASIF JAVED, MS-PT
a.javed@riphah.edu.pk923224209422
PRINCIPAL_INVESTIGATORFATIMA TARIQ, MS-PT

Riphah International University

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 21, 2026