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临床试验/NCT06973460
NCT06973460已完成不适用

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

Gulf Medical University1 个研究点 分布在 1 个国家目标入组 36 人开始时间: 2025年1月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
36
试验地点
1
主要终点
Hunova Evaluation Tools:

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Double (Participant, Care Provider)

入排标准

年龄范围
60 Years 至 85 Years(Adult, Older Adult)
性别
All
接受健康志愿者
是

入选标准

  • •60 years old to 85 years old - young to Old Individuals.
  • •Mini Mental Scale Examination Score >
  • •Able to walk independently with and without mild assistance (Berg's Balance Score between 35 and 45)

排除标准

  • •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.

研究组 & 干预措施

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

干预措施: Otago Exercise Programme (Other)

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

干预措施: Robotic Assisted System (Device)

结局指标

主要结局

Hunova Evaluation Tools:

时间窗: 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.

次要结局

  • Berg's Balance Scale (BBS)(Baseline and 12 weeks)
  • Functional Gait Assessment (FGA):(Baseline and 12 weeks)
  • Star Excursion Balance Test (SEBT)(Baseline and 12 weeks)
  • Fall Efficacy Scale- International (FES-I):(Baseline and 12 weeks)

研究者

发起方
Gulf Medical University
申办方类型
Other
责任方
Sponsor

研究点 (1)

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