Feasibility and Acceptability of HOLOBalance Compared to Standard Care in Older Adults at Risk for Falls (HOLOBALANCE)

King's College London

Status: Unknown

Conditions: Aging; Accidental Falls; Vestibular Disorder

Treatments: Other: OTAGO Home Exercise Programme; Device: HOLOBalance

Study type: Interventional

Funder types: Other

Identifiers

NCT04053829

76957

Details and patient eligibility

About

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.

Enrollment: 120 estimated patients

Sex: All

Ages: 65 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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

Exclusion criteria

• 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

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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120 participants in 2 patient groups

HOLOBalance

Experimental group

Description:

The experimental arm will use the HOLOBalance tele-rehabilitation system to provide the intervention. Participants will be required to use the HOLOBalance system on a daily basis for the duration of the 8 week study. Although participants will have daily interaction with the HOLOBalance system, they will be free to choose when to complete their exercises.

Treatment:

Device: HOLOBalance

OTAGO Home Exercise Programme

Active Comparator group

Description:

The comparator for this study is the OTAGO home exercise programme. The OTAGO is a systematic, progressive strength and balance training programme and is supported by a comprehensive workbook that provides written and pictorial instructions for each exercise. The OTAGO is well-established and is widely used in clinical practice in the UK for the management of older adults who fall or have increased risk for falling. It has been shown to be well tolerated in older adults in community settings with good adherence rates, and reduces falls rate in older adults by 35%, with greatest effects observed in frailer older women

Treatment:

Other: OTAGO Home Exercise Programme