- ICH GCP
- Registr klinických studií v USA
- Klinická studie 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.
Přehled studie
Postavení
Podmínky
Detailní popis
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.
Typ studie
Zápis (Odhadovaný)
Fáze
- Nelze použít
Kontakty a umístění
Studijní kontakt
- Jméno: Sau Lan Tsang, PhD
- Telefonní číslo: +852 3400 8965
- E-mail: charlotte-sl.tsang@polyu.edu.hk
Studijní místa
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Hong Kong, Hongkong
- Nábor
- The Hong Kong Polytechnic University
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Kontakt:
- Sau Lan Tsang, PhD
- Telefonní číslo: +852 3400 8965
- E-mail: charlotte-sl.tsang@polyu.edu.hk
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Kritéria účasti
Kritéria způsobilosti
Věk způsobilý ke studiu
Přijímá zdravé dobrovolníky
Pohlaví způsobilá ke studiu
Popis
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.
Studijní plán
Jak je studie koncipována?
Detaily designu
- Primární účel: Podpůrná péče
- Přidělení: Randomizované
- Intervenční model: Paralelní přiřazení
- Maskování: Singl
Zbraně a zásahy
Skupina účastníků / Arm |
Intervence / Léčba |
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Experimentální: 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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Aktivní komparátor: 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. |
Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
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Postural stability
Časové okno: Pre-intervention, 1 week after intervention and 4 months after intervention.
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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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Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
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Number of real-life falls
Časové okno: 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
Časové okno: Pre-intervention, 1 week after intervention and 4 months after intervention.
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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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: Pre-intervention, 1 week after intervention and 4 months after intervention.
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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
Časové okno: Pre-intervention.
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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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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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První zveřejněno (Aktuální)
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Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
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