Down SyndromeNCT07484464
Effects of the Otago Exercise Program on Balance, Endurance, and Motor Coordination in Children With Down Syndrome
A study testing OTAGO Exercises and Conventional Physical Therapy in people with Down Syndrome, run by Riphah International University at 1 site in Pakistan.
Trial 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. Read more about this study
- Who is it for?
- Ages 8 to 14 years
- Conditions the study is for
- Down Syndrome
- What is being tested?
- OTAGO Exercises and Conventional Physical Therapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 sitePakistan
- Study dates
- 2 Mar 2026to 29 Jul 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 8 to 14 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- • Clinically diagnosed with Trisomy 21.
- Aged between 8-14 years.(29)
- Able to follow basic verbal instructions.
- Ambulatory with or without assistive devices
Who cannot join
- • 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 locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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
- Conditions
- Down Syndrome
- Being tested
- OTAGO Exercises, Conventional Physical Therapy
- Keywords
- Balance,, Motor Coordination, Endurance, OTAGO Exercises
- Medical subject headings
- Down Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OTAGO ExercisesOther
- 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
Conventional Physical TherapyOther
walking components targeted walking Pattern gait speed and duration to support lower limb strength, balance and endurance 3 session per week for 12 weeks
| Study group | Role | What they receive |
|---|---|---|
| OTAGO Exercises+ Conventional Physical Therapy | Experimental | Researcher give OTAGO exercises and conventional physical therapy Receives: Other: OTAGO Exercises |
| conventional Physical Therapy | Other | Researcher give conventional physical therapy Receives: Other: Conventional Physical Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
Measured: 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.
Measured: 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.
Measured: Baseline, 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Mar 2026
- Study start2 Mar 2026
- Primary completion25 Jul 2026
- Study completion29 Jul 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Down SyndromeStudies of the same condition, open and under way.
- More trials run by Riphah International UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- The study will use a randomized control trial 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.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Riphah International University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- FATIMA TARIQ, MS-PT, Principal investigator, Riphah International University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07484464
- Sponsor's protocol ID
- REC/RCR&AHS/25/0749
- Status last verified
- Sep 2026
- First submitted
- 16 Mar 2026
- Last updated
- 28 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 20817938
Study at a glance
From the registry record, last updated by the sponsor on 28 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of OTAGO Exercise Program On Balance, Endurance And Motor Coordination In Children With Down Syndrome
- ClinicalTrials.gov ID
- NCT07484464
- Acronym / sponsor ID
- REC/RCR&AHS/25/0749
- Conditions
- Down Syndrome
- Keywords
- Balance,, Motor Coordination, Endurance, OTAGO Exercises
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Riphah International UniversityUniversity, hospital or other
- Study start
- 2 Mar 2026 (actual)
- Primary completion
- 25 Jul 2026 (actual)
- Study completion
- 29 Jul 2026 (actual)
- First posted
- 20 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- The study will use a randomized control trial 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.
| Arm | Type | Receives |
|---|---|---|
| OTAGO Exercises+ Conventional Physical Therapy | Experimental | Other: OTAGO ExercisesResearcher give OTAGO exercises and conventional physical therapy |
| conventional Physical Therapy | Other | Other: Conventional Physical TherapyResearcher give conventional physical therapy |
Who may qualify
- Ages
- 8 to 14 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- • Clinically diagnosed with Trisomy 21.
Key exclusion criteria (4 listed)
- • Severe visual or auditory impairments.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| OTAGO Exercises1. 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 | Other | OTAGO Exercises+ Conventional Physical Therapy |
| Conventional Physical Therapywalking components targeted walking Pattern gait speed and duration to support lower limb strength, balance and endurance 3 session per week for 12 weeks | Other | conventional Physical Therapy |
Primary outcome
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.
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
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.
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Sep 2026.
- Background: PubMed 20817938Thomas 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
FATIMA TARIQ, MS-PT principal investigator
Riphah International University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing OTAGO Exercises and Conventional Physical Therapy in people with Down Syndrome, run by Riphah International University at 1 site in Pakistan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Bruininks-Oseretsky Test of Motor Proficiency (time frame: Baseline, 8 weeks). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07484464, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Sep 2026; AzTrials last refreshed its copy on 6 Nov 2026.