A Phase 2 Study to Investigate the Feasibility and Acceptability of the HOLOBalance System Compared to Standard Care in Older Adults at Risk for Falls: a Multi-site Study
试验速览
- 阶段
- 不适用
- 入组人数
- 120
- 试验地点
- 2
- 主要终点
- Acceptability Assessment 2: Programme Compliance
研究概览
简要总结
This study will utilise an assessor blinded, randomised controlled design to investigate the acceptability and feasibility of providing a novel tele-rehabilitation balance training system (HOLOBalance) for community dwelling older adults at risk for falls. Older adults (age 65-80) who meet the inclusion criteria (e.g. independently living, no neurological conditions) will be recruited from falls services and from the wider community (via AgeUK) and will be randomly allocated to receive either a prescribed exercise programme delivered by: 1) the HOLOBalance tele-rehabilitation system or 2) an exercise booklet (The OTAGO Home Exercise Programme). Participants will be required to perform a series of prescribed exercises each day (duration of up to 30 minutes per day) for the entirety of the 8-week exercise programme. These exercises will be provided via the HOLOBalance tele-rehabilitation system (intervention arm) or by written instructions (control arm).
Primary objectives for this study are to assess recruitment rate, compliance with exercise programmes (exercise diaries) and drop-out rates within the intervention group and a control group undertaking standard practice, home based balance rehabilitation (the OTAGO Home Exercise Programme) to explore whether HOLOBalance is acceptable to participants. Furthermore, acceptability to older adults will also be investigated via exit interviews performed within the HOLOBalance tele-rehabilitation intervention arm.
Feasibility will be assessed by documenting adverse events (and SAE's), adverse device effects (and SADE's), deviations from protocol and feedback from treating clinicians. Implementation issues such as technology break down, service delivery and usability issues will also be documented. Secondary outcomes to explore trends for effectiveness will investigate performance of both groups at baseline and after the 8 week intervention across a range of outcome measures associated with balance function and falls risk, cognitive function, Physical activity and social participation, and subjective report of mobility and balance.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Single (Outcomes Assessor)
盲法说明
Only the outcome assessor will be masked in this study
入排标准
- 年龄范围
- 65 Years 至 80 Years（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Independent community-dwelling participants able to walk 500 meters independently or with a stick
- •No significant visual impairment
- •Able to understand and to consent to the research
- •A score of >22 on the MoCA, i.e. adults with no or mild cognitive impairment;
- •At risk of falls (i.e. FGA less than 22/30), have significant fear of falling (FESI short form >10) or having experienced a fall/s in the last 12 months
- •Willing to participate and to comply with the proposed training and testing regime.
- •Available space of 1x2 metres at home and sufficient home broadband to allow the system to operate as designed
排除标准
- •Orthostatic hypotension or uncontrolled hypertension
- •Have depression i.e. a score of >10 at the Geriatric depression scale
- •Have cognitive impairment as indicated by the MoCA score(score <22)
- •Other neurological problem (stroke, Parkinson's, peripheral neuropathy)
- •Acute musculo-skeletal injury that prevents participation in a structured exercise programme (e.g. lower limb fracture)
- •No internet connection at home
- •Has participated in a clinical drug trial in the past 6 months
- •Currently receiving falls and/or cognitive rehabilitation.
- •Has an implanted medical device or cardiac pacemaker
结局指标
主要结局
Acceptability Assessment 2: Programme Compliance
时间窗: Through study completion (12 months)
Comparison of compliance with exercise programmes (% of sessions completed) within the intervention group and a control group undertaking standard practice, home based balance rehabilitation (the OTAGO Home Exercise Programme).
Feasibility of providing HOLOBalance 2: Monitoring for deviations from study protocol
时间窗: Through study completion (12 months)
Assessment of any deviations from protocol reported logged in the site files using the deviation from protocol form.
Acceptability Assessment 1: Recruitment Rate
时间窗: Through study completion (12 months)
Assessment of recruitment rate of study (% of eligible participants enrolled)
Feasibility of providing HOLOBalance 1: Monitoring of Adverse and Serious Adverse Events
时间窗: Through study completion (12 months)
Feasibility will be assessed by documenting adverse events (and SAE's) and adverse device effects (and SADE's).
Acceptability Assessment 3: Drop out rate
时间窗: Through study completion (12 months)
Comparison of drop-out rates (%) between the intervention group and a control group undertaking standard practice, home based balance rehabilitation (the OTAGO Home Exercise Programme).
Acceptability 4: Qualitative interview
时间窗: Collected at end of each participants participation in the study (After 8 weeks)
Acceptability of HOLOBalance to older adults will be investigated via exit interviews performed within the tele-rehabilitation intervention arm.
次要结局
- Subjective Questionnaire(Baseline (Week 0) and Follow up (Week 9))
- Balance Function Assessment(Baseline (Week 0) and Follow up (Week 9))
- Cognitive Function Assessment(Baseline (Week 0) and Follow up (Week 9))