Robotic-Assisted System in Enhancing Balance, Postural Stability, Functional Gait and Fall Efficacy in Older Adults

Not Applicable

Recruiting

• Conditions: Aged; Aged Healthy Volunteer; Geriatric; Balance; Fall Risk, Fall Prevention

• Registration Number: NCT06973460
• Lead Sponsor: Gulf Medical University

Brief Summary

Our study aims to investigate the effectiveness of a more individualized and personalized feedback-oriented approach using the Hunova Robotic Systems. 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 Traditional Balance and Mobility Exercise which are more generalized. Given the generalized nature of Traditional approaches, we aim to compare it with the Hunova Robotic 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 Hunova Robotic System 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 Traditional Balance and Mobility Exercise Protocols. This research aims to investigate the effectiveness of Movendo's Hunova 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 Hunova Robotic System on Fall Efficacy, Functional Gait and postural stability with traditional balance and Mobility Exercise Protocols.

Study Timeline

• Study Start: 2025-01-01
• Status Verified: 2025-05
• Study First Submitted: 2025-05-07
• Study First Submitted QC: 2025-05-07
• Study First Posted: 2025-05-15
• Last Update Submitted: 2025-05-26
• Last Update Posted: 2025-05-30
• Primary Completion: 2025-06-15
• Study Completion: 2025-06-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 36

Inclusion Criteria

• 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)

Exclusion Criteria

• 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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Hunova Evaluation Tools:	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.

Secondary Outcome Measures

Name	Time	Method
Berg's Balance Scale (BBS)	Baseline and 12 weeks	A Gold Standard in the assessment of Balance Impairments; Score range: 0 to 56; Interpretation: Higher scores indicate better balance and lower fall risk.
Functional Gait Assessment (FGA):	Baseline and 12 weeks	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
Star Excursion Balance Test (SEBT)	Baseline and 12 weeks	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.
Fall Efficacy Scale- International (FES-I):	Baseline and 12 weeks	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

Trial Locations

Locations (1)

Thumbay Physical Therapy and Rehabilitation Hospital; 🇦🇪 Ajman, United Arab Emirates