About this trial
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 criteria
This trial does not accept healthy volunteersQualifiers
• Clinically diagnosed with Trisomy 21.
Aged between 8-14 years.(29)
Able to follow basic verbal instructions.
Ambulatory with or without assistive devices
Disqualifiers
• 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
Trial design
Single group
Treatments tested in this trial
OTAGO Exercises
Other intervention1. 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
Treatment groups
Trial outcomes
Primary outcomes
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.
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
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.
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.
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