AgedROB-BSTNCT06973460
Robotic-Assisted System in Enhancing Balance, Postural Stability, Functional Gait and Fall Efficacy in Older Adults
A study testing Robotic Assisted System and Otago Exercise Programme in people with Aged and Aged Healthy Volunteer, run by Gulf Medical University at 1 site in United Arab Emirates.
Trial summary
Our study aims to investigate the effectiveness of a more individualized and personalized feedback-oriented approach using a Robotic Assisted System, the Hunova Movendo Robotic System. Read more about this study
- Who is it for?
- Ages 60 to 85 yearsHealthy volunteers can take part
- Conditions the study is for
- Aged, Aged Healthy Volunteer, Geriatric
- What is being tested?
- Robotic Assisted System and Otago Exercise Programme
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 siteUnited Arab Emirates
- Study dates
- 1 Jan 2025to 30 Jun 2025
- 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 60 to 85 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 60 years old to 85 years old - young to Old Individuals.
- Mini Mental Scale Examination Score > 24.
- Able to walk independently with and without mild assistance (Berg's Balance Score between 35 and 45)
Who cannot join
- Unable to understand and follow instructions.
- History of vestibular dysfunction.
- Any severe Musculoskeletal problems restricting mobility.
- Current Physiotherapy training or balance exercises focusing on proprioception or fall risk.
Trial locations and contacts
1 site in 1 country.
United Arab Emirates1 site
Thumbay Physical Therapy and Rehabilitation Hospital
Ajman
About this study
Official title: Investigating the Role of a Robotic-Assisted System in Enhancing Balance, Postural Stability, Functional Gait and Fall Efficacy in Older Adults Compared to Otago Exercise Programme - A Pilot Study
Our study aims to investigate the effectiveness of a more individualized and personalized feedback-oriented approach using a Robotic Assisted System, the Hunova Movendo Robotic System. This system is tailored to specific needs of individuals and is dynamically adjustable relative to patients' balance and functional demands. It will be compared to Otago Exercise Programme which is more generalized. Given the generalized nature of the Otago Exercise Programme, we aim to compare it with the Robotic Assisted Systems in the enhancement of Balance, Postural Stability, Functional Gait and Fall Efficacy in older adults.
Read the detailed description
Aging comes with increased risk of fall and a steep decline in adequate motor functioning, as such due to the decline in proprioception, balance and general functional independence the risk of falls and injury is high in aging adults impacting quality of life.
Traditional approaches like the Otago Exercise Programmes (and other Balance and Mobility exercise protocols) have been relatively effective in the management of falls yet there's a remarkable and persistent increase in fall rates, postural instability and functional gait limitations in older adults largely due to the generalized nature of these protocols. The limitations of these traditional approaches in individualizing treatment protocols created a need for advanced and more dynamic systems that can fill this gap and/or complement these traditional approaches.
Modern Technology, including Hunova Robotic systems are novel approaches that seek to solve these limitations by tailoring interventions to patients' needs creating real time feedback mechanisms assisting in intervention prescriptions and analysis. The preciseness of these modern systems assist in creating integrated systems that enhance organization of these interventions improving overall outcomes.
Literature supporting the use of the Robotic Assisted Systems on Fall efficacy, postural stability and functional gait is very limited, necessitating a need for studies comparing the effectiveness of this technology on these components compared to Otago Exercise Programme. This research aims to investigate the effectiveness of a Robotic Assisted System in improving fall efficacy, postural stability and functional gait in older adults and in general geriatric rehabilitation. With the increased emphasis on robotic-assisted rehabilitation due to its accuracy, individualized patient focused design and feedback mechanisms, the study becomes all the more imperative.
This Research attempts to compare the Robotic Assisted System on Fall Efficacy, Functional Gait and postural stability with Otago Exercise Programme.
- Conditions
- Aged, Aged Healthy Volunteer, Geriatric, Balance, Fall Risk, Fall Prevention
- Being tested
- Robotic Assisted System, Otago Exercise Programme
- Keywords
- Robotic System, Hunova, Balance, Older Adults, Fall Efficacy, Functional Gait, Robotic-assisted System, Balance and Mobility Exercise, Otago Exercise Programme
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Robotic Assisted SystemDevice
Hunova Movendo Robotic System
Otago Exercise ProgrammeOther
Otago Exercise Programme
| Study group | Role | What they receive |
|---|---|---|
| Robotic Assisted Group Using the Hunova Movendo Robotic Device. | Experimental | Balance Training on Robotic Assisted System:
Bipodalic Stance: On Static platform; Elastic Platform, Fluid platform, Wobble Base, Balance on variable counter resistance platform, Sagittal Lunges.
Monopodalic (Left \& Right): On Static platform; Elastic Platform, Fluid platform, Wobble Base, Balance on variable counter resistance platform, Isometric Ankle.
Strengthening: Balance on Counter-resistance platform, raises, Ping Pong on Elastic platform, Bipodalic Sit to Stand
Mobility and Gait: Bipodalic Stance: Balance on Elastic Platform, Balance on Fluid Platform, Balance on Proprioceptive Platform, Balance on Linear PAssive
Combined Passive platform, Balance on Passive Spiral Base.
In addition: Stair walking on standardized stairs.
Rest Period: 5 mins incorporated in between intervention. Duration : 45 minutes/day
Frequency:
2 days per week for a period of 12 weeks Receives: Device: Robotic Assisted System |
| Otago Exercise Programme | Active comparator | * Strengthening Training:
* Knee Extensor
* Knee Flexor
* Hip Adductor
* Ankle plantarflexors (calf Raises)
* Ankle dorsiflexors (toe raises)
* Balance Training:
* Knee Bends
* Backwards walking
* Walking and turning around
* Sideways walking
* Tandem Stance (heel toe stand)
* Tandem Walk (Heel toe Walk)
* One Leg Stand
* Heel walking
* Toe Walk
* Heel Toe Walking backwards
* Sit to Stand
* Stair walking
Rest Period: 5mins incorporated in-between intervention. Duration : 45 minutes/day
Frequency:
2 days per week for a period of 12 weeks Receives: Other: Otago Exercise Programme |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hunova Evaluation Tools:
Hunova's precise assessment tools assist clinicians tailor prevention interventions with Quantitative data.
Assessment Domains:
Static \& dynamic postural control Visual dependency in balance (Romberg Index) Trunk stability Functional sit-to-stand transitions Limits of stability
Scoring:
No single cumulative score; results are reported through individual biomechanical parameters such as:
Sway Area (cm²) (CE,OE) COP Path Length (cm) (CE,OE) Romberg Index (unitless ratio) Trunk Oscillation Range (deg) (multi directionally) (CE,OE) 5x Sit-to-Stand Duration (seconds) Limits of Stability (LoS) (cm) (Max COP \& LEAN multi directionally).
Interpretation:
Lower values (individualized normative values) in Sway Area, Path Length, \& Romberg Index indicate better balance, greater postural control, \& lower fall risk.
Higher values (individualized normative values) in Trunk Oscillation, LoS \& Sit-to-Stand times reflect reduced functional stability \& potential impairments in dynamic control.
Measured: Baseline and 12 weeks
Secondary outcomes (4)
Berg's Balance Scale (BBS)
A Gold Standard in the assessment of Balance Impairments
Score range: 0 to 56
Interpretation: Higher scores indicate better balance and lower fall risk.
Measured: Baseline and 12 weeks
Star Excursion Balance Test (SEBT)
This test assesses dynamic balance by measuring reach distance while balancing on one leg in various directions. Used to detect deficits in balance and flexibility, it has an interrater reliability and has been validated in the identification of balance deficits in lower extremity. It is useful in assessment of the functional strength of older adults as they're prone to balance, proprioception and flexibility decline.
Range: Reach distance measured in centimeters; often normalized to leg length.
Intepretation: Greater reach distance indicates better dynamic postural control.
Measured: Baseline and 12 weeks
Functional Gait Assessment (FGA):
FGA is an assessment scoring scale that measures gait stability under different conditions and tasks. It ranges from 0-30. Lower scores signify higher gait impairments. It has an interrater reliability (ICC > 0.9). It also has high sensitivity to functional gait changes supporting its use care in baseline and follow up assessments in Older Adults
Measured: Baseline and 12 weeks
Fall Efficacy Scale- International (FES-I):
FES-I is a 16 to 64 self-reporting tool that is used to assess confidence in performing activities without the risk of fall. Higher scores signify a greater fear of falling. It gives insight on how much the fear of falling influences activities. It has an internal consistency (Cronbach's Alpha > 0.9) suggesting reliability and validity in research
Measured: Baseline and 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 May 2025
- Study start1 Jan 2025
- Primary completion15 Jun 2025
- Study completion30 Jun 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AgedStudies of the same condition, open and under way.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- Gulf Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Meruna Bose, PHD, Study chair, Gulf Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06973460
- Sponsor's protocol ID
- IRB-COHS-STD-96-Nov-2024
- Acronym
- ROB-BST
- Status last verified
- May 2025
- First submitted
- 7 May 2025
- Last updated
- 7 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Data might be shared based on the request
Study at a glance
From the registry record, last updated by the sponsor on 7 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigating the Role of a Robotic-Assisted System in Enhancing Balance, Postural Stability, Functional Gait and Fall Efficacy in Older Adults Compared to Otago Exercise Programme - A Pilot Study
- ClinicalTrials.gov ID
- NCT06973460
- Acronym / sponsor ID
- ROB-BST / IRB-COHS-STD-96-Nov-2024
- Conditions
- Aged, Aged Healthy Volunteer, Geriatric, Balance, Fall Risk, Fall Prevention
- Keywords
- Robotic System, Hunova, Balance, Older Adults, Fall Efficacy, Functional Gait, Robotic-assisted System, Balance and Mobility Exercise
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- Gulf Medical UniversityUniversity, hospital or other
- Study start
- 1 Jan 2025 (actual)
- Primary completion
- 15 Jun 2025 (actual)
- Study completion
- 30 Jun 2025 (actual)
- First posted
- 15 May 2025 (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.
Our study aims to investigate the effectiveness of a more individualized and personalized feedback-oriented approach using a Robotic Assisted System, the Hunova Movendo Robotic System. This system is tailored to specific needs of individuals and is dynamically adjustable relative to patients' balance and functional demands. It will be compared to Otago Exercise Programme which is more generalized. Given the generalized nature of the Otago Exercise Programme, we aim to compare it with the Robotic Assisted Systems in the enhancement of Balance, Postural Stability, Functional Gait and Fall Efficacy in older adults.
Detailed description
Aging comes with increased risk of fall and a steep decline in adequate motor functioning, as such due to the decline in proprioception, balance and general functional independence the risk of falls and injury is high in aging adults impacting quality of life.
Traditional approaches like the Otago Exercise Programmes (and other Balance and Mobility exercise protocols) have been relatively effective in the management of falls yet there's a remarkable and persistent increase in fall rates, postural instability and functional gait limitations in older adults largely due to the generalized nature of these protocols. The limitations of these traditional approaches in individualizing treatment protocols created a need for advanced and more dynamic systems that can fill this gap and/or complement these traditional approaches.
Modern Technology, including Hunova Robotic systems are novel approaches that seek to solve these limitations by tailoring interventions to patients' needs creating real time feedback mechanisms assisting in intervention prescriptions and analysis. The preciseness of these modern systems assist in creating integrated systems that enhance organization of these interventions improving overall outcomes.
Literature supporting the use of the Robotic Assisted Systems on Fall efficacy, postural stability and functional gait is very limited, necessitating a need for studies comparing the effectiveness of this technology on these components compared to Otago Exercise Programme. This research aims to investigate the effectiveness of a Robotic Assisted System in improving fall efficacy, postural stability and functional gait in older adults and in general geriatric rehabilitation. With the increased emphasis on robotic-assisted rehabilitation due to its accuracy, individualized patient focused design and feedback mechanisms, the study becomes all the more imperative.
This Research attempts to compare the Robotic Assisted System on Fall Efficacy, Functional Gait and postural stability with Otago Exercise Programme.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Robotic Assisted Group Using the Hunova Movendo Robotic Device. | Experimental | Device: Robotic Assisted SystemBalance Training on Robotic Assisted System: Bipodalic Stance: On Static platform; Elastic Platform, Fluid platform, Wobble Base, Balance on variable counter resistance platform, Sagittal Lunges. Monopodalic (Left \& Right): On Static platform; Elastic Platform, Fluid platform, Wobble Base, Balance on variable counter resistance platform, Isometric Ankle. Strengthening: Balance on Counter-resistance platform, raises, Ping Pong on Elastic platform, Bipodalic Sit to Stand Mobility and Gait: Bipodalic Stance: Balance on Elastic Platform, Balance on Fluid Platform, Balance on Proprioceptive Platform, Balance on Linear PAssive Combined Passive platform, Balance on Passive Spiral Base. In addition: Stair walking on standardized stairs. Rest Period: 5 mins incorporated in between intervention. Duration : 45 minutes/day Frequency: 2 days per week for a period of 12 weeks |
| Otago Exercise Programme | Active comparator | Other: Otago Exercise Programme* Strengthening Training: * Knee Extensor * Knee Flexor * Hip Adductor * Ankle plantarflexors (calf Raises) * Ankle dorsiflexors (toe raises) * Balance Training: * Knee Bends * Backwards walking * Walking and turning around * Sideways walking * Tandem Stance (heel toe stand) * Tandem Walk (Heel toe Walk) * One Leg Stand * Heel walking * Toe Walk * Heel Toe Walking backwards * Sit to Stand * Stair walking Rest Period: 5mins incorporated in-between intervention. Duration : 45 minutes/day Frequency: 2 days per week for a period of 12 weeks |
Who may qualify
- Ages
- 60 to 85 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 60 years old to 85 years old - young to Old Individuals.
- Mini Mental Scale Examination Score > 24.
- Able to walk independently with and without mild assistance (Berg's Balance Score between 35 and 45)
Key exclusion criteria (4 listed)
- Unable to understand and follow instructions.
- History of vestibular dysfunction.
- Any severe Musculoskeletal problems restricting mobility.
- Current Physiotherapy training or balance exercises focusing on proprioception or fall risk.
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 |
|---|---|---|
| Robotic Assisted SystemHunova Movendo Robotic System | Device | Robotic Assisted Group Using the Hunova Movendo Robotic Device. |
| Otago Exercise ProgrammeOtago Exercise Programme | Other | Otago Exercise Programme |
Primary outcome
Hunova Evaluation Tools:
Time frame: Baseline and 12 weeks
Hunova's precise assessment tools assist clinicians tailor prevention interventions with Quantitative data. Assessment Domains: Static \& dynamic postural control Visual dependency in balance (Romberg Index) Trunk stability Functional sit-to-stand transitions Limits of stability Scoring: No single cumulative score; results are reported through individual biomechanical parameters such as: Sway Area (cm²) (CE,OE) COP Path Length (cm) (CE,OE) Romberg Index (unitless ratio) Trunk Oscillation Range (deg) (multi directionally) (CE,OE) 5x Sit-to-Stand Duration (seconds) Limits of Stability (LoS) (cm) (Max COP \& LEAN multi directionally). Interpretation: Lower values (individualized normative values) in Sway Area, Path Length, \& Romberg Index indicate better balance, greater postural control, \& lower fall risk. Higher values (individualized normative values) in Trunk Oscillation, LoS \& Sit-to-Stand times reflect reduced functional stability \& potential impairments in dynamic control.
4 secondary outcomes
Berg's Balance Scale (BBS)
Time frame: Baseline and 12 weeks
Star Excursion Balance Test (SEBT)
Time frame: Baseline and 12 weeks
Functional Gait Assessment (FGA):
Time frame: Baseline and 12 weeks
Fall Efficacy Scale- International (FES-I):
Time frame: Baseline and 12 weeks
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 7 Jul 2026.
- Individual participant dataSharing planned: No. Data might be shared based on the request
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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.
Meruna Bose, PHD study chair
Gulf Medical 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 Robotic Assisted System and Otago Exercise Programme in people with Aged and Aged Healthy Volunteer, run by Gulf Medical University at 1 site in United Arab Emirates.
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 3 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 7 Jul 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 United Arab Emirates. 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?
Hunova Evaluation Tools: (time frame: Baseline and 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 7 Jul 2026.