Clinical trial NCT04751097: The iCARE Feasibility Study
Official title: The Intelligent Community Active Rehab for the Elderly Study Feasibility Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Accidental Fall
Keywords: feasibility
Lead sponsor: CUSH Health Ltd.
Sponsor class: INDUSTRY
Collaborators: name: University of Sussex
First posted: 2021-02-11
Enrollment: 30
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Conducting assessment lower limb muscle strength, power and joint range of movement as well as inertial measurement unit (IMU) data capture during periods of walking and activities of daily living (sit to stand, stand to sit, climbing stairs) in participants over the age of 65. Assessing to see if there is any correlation between prospective follow up for incidence of fall events and patterns observed in the IMU data of the subject and to assess if the IMU data observed that results in higher or lower incidence of falls is related to any particular pattern in lower limb muscle strength, power and joint range of movement data.

Detailed description: Research Question:

• What is the feasibility of conducting a large scale study to identify modifiable musculoskeletal factors, increasing the risk of falls in older adults; that can be detected in mobility data collected from a wearable device worn during activities of daily living?

Primary aim:

• To collect feasibility data on study processes, resource and management.

Secondary aims:

* Assess the preliminary efficacy of 'Wearable technology' in predicting falls risk in older adults during activities of daily living.
* Assess the preliminary efficacy of identifying musculoskeletal factors predisposing to mobility issues that are associated with or protective against falls.
* Assess the preliminary efficacy of specifically treating these musculoskeletal factors compared with traditional care?

Eligibility criteria: Inclusion Criteria:

* Aged over 65 years of age
* Able to give informed consent
* Able to mobilise independently or with mobility aid (walking stick, Zimmer frame etc.)

Exclusion Criteria:

* Patients under the age of 65.
* Patients who are bedbound or wheelchair bound.
* Patients with cognitive impairment and are unable to give informed consent.
* Significant medical co-morbidities that make participation in the study unsafe.

Primary outcomes:
measure: Total number of events fall at 1 week.
timeFrame: Recorded at day 7.
measure: Total number of events fall at 2 weeks.
timeFrame: Recorded at day 14.
measure: Total number of events fall at 1 month.
timeFrame: Recorded at day 30.
measure: Total number of events fall at 3 months.
timeFrame: Recorded at day 90.
measure: Total number of events fall at 6 months.
timeFrame: Recorded at day 180.
Secondary outcomes:
measure: Timed up and go test (TUG test)
timeFrame: Completed at Day 1 and at the 6 months follow up.
measure: Thirty second sit to stand test
timeFrame: Completed at Day 1 and at the 6 months follow up.
measure: 2 min walk test
timeFrame: Completed at Day 1 and at the 6 months follow up.
measure: Grip strength
timeFrame: Completed at Day 1 and at the 6 months follow up.
measure: Timed stair climb
timeFrame: Completed at Day 1 and at the 6 months follow up.
measure: Physical activity scale for the elderly (PASE) questionnaire
timeFrame: Completed at Day 1 and at the 6 months follow up.
measure: Short musculoskeletal function assessment (SMFA) questionnaire
timeFrame: Completed at Day 1 and at the 6 months follow up.
measure: Previous fall event history questions
timeFrame: Completed at Day1.
Other outcomes:
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