- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07860619
Reactive Balance Training in Augmented Reality for Older Adults
The Combined Effects of Reactive Balance Training in an Augmented Reality Environment on Postural Stability in Community-dwelling Older Adults With an Increased Risk of Falling: A Randomized Controlled Trial
This is a single-blinded study. The participants will be equally randomized to either the reactive balance training with augmented reality (RBT+AR) group or the control (treadmill walking) group. Changes in postural stability, functional mobility/strength, balance performance, quality of life, balance confidence, muscle activation, and executive function following RBT+AR compared to treadmill walking only will be investigated.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
This randomized controlled trial will recruit thirty-six community-dwelling older adults with increased fall risk. The participants will be equally randomized to either the RBT+AR group or the control group. The RBT+AR group will receive two sessions of treadmill-based RBT with 224 forward and backward perturbations, simulating tripping and slipping, while walking with AR headsets, and the control group will receive two sessions of treadmill walking without perturbation and AR. Between-group differences in behavior will be examined before and after training to identify training-induced changes in postural stability. Retention of the changes in the postural stability will be assessed four months after the training period. Incidents of falls will be followed up for 12 months after training.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Sau Lan Tsang, PhD
- Phone Number: +852 3400 8965
- Email: charlotte-sl.tsang@polyu.edu.hk
Study Locations
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Hong Kong, Hong Kong
- Recruiting
- The Hong Kong Polytechnic University
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Contact:
- Sau Lan Tsang, PhD
- Phone Number: +852 3400 8965
- Email: charlotte-sl.tsang@polyu.edu.hk
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Community-dwelling adults aged 60 years old or older
- Able to communicate effectively in Cantonese or Mandarin
- Able to walk independently on level ground for at least 30 minutes
- Abbreviated Mental Test (Hong Kong version) scores > 6
- Have fallen in the preceding year, have concerns about falling, or feel unsteady while walking or standing.
Exclusion Criteria:
- Uncorrected vision or hearing impairment
- Osteoporosis
- Have a history of hip or knee replacement
- Resting blood pressure ≥ 160/100 mmHg
- Resting heart rate exceeds the 60-100 beat/min normal range
- Have musculoskeletal conditions causing pain or functional limitation that would preclude safe performance of study procedures (e.g., acute fracture)
- Have cardiovascular conditions that may pose risks during training or assessment (e.g., uncontrolled arrhythmias)
- Have mental health conditions impairing decision-making capacity or ability to comply with study instructions (e.g., psychosis)
- Have neurological conditions affecting balance, coordination in a way that would increase safety risk (e.g., Parkinson's disease)
- Participating or planning to participate in another fall prevention program.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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Experimental: Reactive balance training with augmented reality group
The group will receive two sessions of treadmill-based reactive balance training with 240 forward and backward perturbations, simulating tripping and slipping, while walking with augmented reality headsets. |
It will be two sessions of treadmill-based RBT with 240 forward and backward perturbations, simulating tripping and slipping, while walking with augmented reality headsets. Each session will last approximately one hour. Participants will be instructed to recover their balance and continue walking after each perturbation. |
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Active Comparator: Control group
The group will receive two sessions of treadmill walking without perturbation and augmented reality. |
It will be a two sessions training with each session lasting for approximately an hour. The same training duration and format will be used as the experimental group, except that no perturbations and augmented reality will be induced during the treadmill walking. |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Postural stability
Time Frame: Pre-intervention, 1 week after intervention and 4 months after intervention.
|
Postural stability at the recovery steps after the perturbation will be calculated as the distance between the absolute center of mass (CoM) position in an anteroposterior direction relative to the closest edge of the Base of Support (BoS) normalized by foot length. The absolute CoM position and BoS position will be traced by the motion capture system synchronized with the force plates embedded underneath the slip-treadmill belts. |
Pre-intervention, 1 week after intervention and 4 months after intervention.
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Number of real-life falls
Time Frame: 1 month, 2 months, 3 months, 4 months, 5 months, 6 months, 7 months, 8 months, 9 months, 10 months, 11 months, and 12 months after the intervention.
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The number of real-life falls in months after randomization will be recorded. Fall circumstances and related injuries will be required via phone contact. A fall is defined as an event resulting in a person unintentionally coming to rest on the ground or other lower level, not as the result of a major intrinsic event (e.g., syncope, stroke, or overwhelming hazard such as an earthquake). |
1 month, 2 months, 3 months, 4 months, 5 months, 6 months, 7 months, 8 months, 9 months, 10 months, 11 months, and 12 months after the intervention.
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Generic balance ability
Time Frame: Pre-intervention, 1 week after intervention and 4 months after intervention.
|
Generic balance ability will be assessed by the Brief-BESTest. Brief-BESTest can challenge balance across anticipatory postural adjustments, postural responses, sensory orientation and stability in gait, allowing for comprehensive examination of improvements that occur in reactive control. As a shortened version of the BESTest, the Brief-BESTest is an 8-item balance assessment containing 1 item for each of the 6 subsections of the BESTest. |
Pre-intervention, 1 week after intervention and 4 months after intervention.
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Mobility
Time Frame: Pre-intervention, 1 week after intervention and 4 months after intervention
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Mobility will be assessed by Timed Up and Go test and Dual-Task Timed Up and Go test (in the unit of seconds) |
Pre-intervention, 1 week after intervention and 4 months after intervention
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Dynamic balance
Time Frame: Pre-intervention, 1 week after intervention and 4 months after intervention.
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Dynamic balance will be assessed by Alternative Step Test (in the unit of seconds). |
Pre-intervention, 1 week after intervention and 4 months after intervention.
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Balance confidence
Time Frame: Pre-intervention, 1 week after intervention and 4 months after intervention.
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Balance confidence will be measured with the Chinese version of the shortened version of Activities-specific Balance Confidence Scale (ABC-6). The scale value is from 0 to 100, with higher values representing higher balance confidence. |
Pre-intervention, 1 week after intervention and 4 months after intervention.
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Functional lower body strength
Time Frame: Pre-intervention, 1 week after intervention and 4 months after intervention.
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Functional lower body strength will be assessed by Five-time Sit to Stand Test (in the unit of seconds). |
Pre-intervention, 1 week after intervention and 4 months after intervention.
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Cognitive flexibility and executive function
Time Frame: Pre-intervention, 1 week after intervention and 4 months after intervention.
|
Cognitive flexibility and executive function will be assessed by Trial Making Tests A and B (in the unit of seconds). |
Pre-intervention, 1 week after intervention and 4 months after intervention.
|
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Cognitive impairment
Time Frame: Pre-intervention.
|
Cognitive impairment will be assessed by Abbreviated Mental Test (AMT). AMT is a 10-item test, with a 10-point scale. A score less than 6 suggests a significant cognitive deficit. |
Pre-intervention.
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Depressive symptoms
Time Frame: Pre-intervention.
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Depressive symptoms will be assessed by Five-Item Geriatric Depression Scale. Participants will be asked to answer 5 questions as yes or no. The answer "no" for the first question and "yes" for the other four questions will be evaluated for depression. |
Pre-intervention.
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Personality traits
Time Frame: Pre-intervention.
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Personality traits assessed by Ten-Item Personality Inventory. It has 10 items, each item adopts a 5-level score of 1 (Disagree strongly) to 5 (Agree strongly), and a higher dimension score indicates a stronger individual's personality proneness. |
Pre-intervention.
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Generic preference-based quality-of-life
Time Frame: Pre-intervention, 1 week after intervention and 4 months after intervention.
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Generic preference-based quality-of-life will be assessed by five-level EuroQol five-dimensional questionnaire (EQ-5D-5L). The EQ-5D-5L essentially consists of 2 parts: the EQ-5D descriptive system and the EQ visual analogue scale (EQ VAS). In the EQ-5D descriptive system, each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems and extreme problems. Each health state is identified by a five-digit code, with 11111 representing the best and 55555 the worst possible health state. In the EQ CAS, the scale value is from 0 to 100, with higher values representing higher balance confidence. |
Pre-intervention, 1 week after intervention and 4 months after intervention.
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Muscle activations
Time Frame: Pre-intervention, 1 week after intervention and 4 months after intervention.
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Muscle activations will be assessed by surface electromyography using an electromyography system (Trigno IM, Delsys Inc., Natick, MA, USA). Fourteen electrodes are placed bilaterally over erector spinae, rectus abdominis, gastrocnemius medialis, biceps femoris, rectus femoris, tibialis anterior, and gluteus medius according to the SENIAM guidelines (www.seniam.org) by the physical therapist. |
Pre-intervention, 1 week after intervention and 4 months after intervention.
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Physical activity
Time Frame: Pre-intervention, and 4 months after intervention.
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Physical activity will be assessed by the Physical Activity Scale for the Elderly. This questionnaire will ask participants to recall their activity over the last 7-days. Activity types include sitting, walking, sport/recreation, exercise, occupational and household. A total score for physical activity can be calculated using these answers and the predetermined weights associated with each activity. |
Pre-intervention, and 4 months after intervention.
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Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- HSEARS20260423001
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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