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

NCT06973460 | Recruiting DMC

• 1 other identifier: IRB-COHS-STD-96-Nov-2024
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

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.

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; Otago Exercise Programme

Outcome Measures

Primary Outcomes (1)

• 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.

  Baseline and 12 weeks

Secondary Outcomes (4)

• Berg's Balance Scale (BBS)

  Baseline and 12 weeks

• Star Excursion Balance Test (SEBT)

  Baseline and 12 weeks

• Functional Gait Assessment (FGA):

  Baseline and 12 weeks

• Fall Efficacy Scale- International (FES-I):

  Baseline and 12 weeks

Study Arms (2)

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

Device: Hunova Robotic-Assisted System

Balance and Mobility Exercises derived from 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

Other: Balance and Mobility Exercise

Interventions

Hunova Robotic-Assisted System DEVICE

Hunova Movendo Robotic System

Robotic Assisted Group Using the Hunova Movendo Robotic Device.

Balance and Mobility Exercise OTHER

Balance and Mobility Exercise derived from the Otago Exercise Programme

Balance and Mobility Exercises derived from Otago Exercise Programme.

Eligibility Criteria

• Age: 60 Years - 85 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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.

Sponsors & Collaborators

• Gulf Medical University: lead

Study Sites (1)

Thumbay Physical Therapy and Rehabilitation Hospital

Ajman, United Arab Emirates

RECRUITING

Study Officials

• Meruna Bose, PHD

  Gulf Medical University

  STUDY CHAIR

Central Study Contacts

DANIEL K ADEJUMO, BPT

CONTACT

+971568319098; danieladejumo30@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 7, 2025
• First Posted: May 15, 2025
• Study Start: January 1, 2025
• Primary Completion: June 15, 2025
• Study Completion: June 30, 2025
• Last Updated: May 30, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

AE (1)