Accidental FalliCARENCT04751097
The iCARE Feasibility Study
A study testing CUSH Health Digital platform in people with Accidental Fall, run by CUSH Health Ltd..
Trial 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. Read more about this study
- Who is it for?
- Ages 65 years and olderHealthy volunteers can take part
- Conditions the study is for
- Accidental Fall
- What is being tested?
- CUSH Health Digital platform
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- No sites listed yet
- Study dates
- 1 Jun 2021to 30 Oct 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- Healthy volunteers accepted
- Older adult
Who may be able to join
- Aged over 65 years of age
- Able to give informed consent
- Able to mobilise independently or with mobility aid (walking stick, Zimmer frame etc.)
Who cannot join
- 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.
About this study
Official title: The Intelligent Community Active Rehab for the Elderly Study Feasibility Study
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.
Read the 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?
- Conditions
- Accidental Fall
- Being tested
- CUSH Health Digital platform
- Keywords
- feasibility
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CUSH Health Digital platformOther
Remote mobility monitoring and physiotherapy video app
| Study group | Role | What they receive |
|---|---|---|
| Digital Platform | Experimental | Not described Receives: Other: CUSH Health Digital platform |
| Routine Care | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total number of events fall at 1 week.
Fall events are defined as an unintended action that leads to loss of balance or an unintended action that leads to unwanted movement towards the floor.
This will be recorded as a numerical value of occurrence; For example if no fall events occur during the follow up period the the primary outcome measure will be reported as 0.
Similarly if a participant has 4 fall events during the follow up period the primary outcome measure will be reported as 4.
The minimum value will be 0 representing no fall events. Primary outcome values trending closer to 0 will be deemed a better outcome with 0 being the best.
There is no defined maximum value but values trending away from 0 will be treated as a worse outcome.
Measured: Recorded at day 7.
Total number of events fall at 2 weeks.
Fall events are defined as an unintended action that leads to loss of balance or an unintended action that leads to unwanted movement towards the floor.
This will be recorded as a numerical value of occurrence; For example if no fall events occur during the follow up period the the primary outcome measure will be reported as 0.
Similarly if a participant has 4 fall events during the follow up period the primary outcome measure will be reported as 4.
The minimum value will be 0 representing no fall events. Primary outcome values trending closer to 0 will be deemed a better outcome with 0 being the best.
There is no defined maximum value but values trending away from 0 will be treated as a worse outcome.
Measured: Recorded at day 14.
Total number of events fall at 1 month.
Fall events are defined as an unintended action that leads to loss of balance or an unintended action that leads to unwanted movement towards the floor.
This will be recorded as a numerical value of occurrence; For example if no fall events occur during the follow up period the the primary outcome measure will be reported as 0.
Similarly if a participant has 4 fall events during the follow up period the primary outcome measure will be reported as 4.
The minimum value will be 0 representing no fall events. Primary outcome values trending closer to 0 will be deemed a better outcome with 0 being the best.
There is no defined maximum value but values trending away from 0 will be treated as a worse outcome.
Measured: Recorded at day 30.
Total number of events fall at 3 months.
Fall events are defined as an unintended action that leads to loss of balance or an unintended action that leads to unwanted movement towards the floor.
This will be recorded as a numerical value of occurrence; For example if no fall events occur during the follow up period the the primary outcome measure will be reported as 0.
Similarly if a participant has 4 fall events during the follow up period the primary outcome measure will be reported as 4.
The minimum value will be 0 representing no fall events. Primary outcome values trending closer to 0 will be deemed a better outcome with 0 being the best.
There is no defined maximum value but values trending away from 0 will be treated as a worse outcome.
Measured: Recorded at day 90.
Total number of events fall at 6 months.
Fall events are defined as an unintended action that leads to loss of balance or an unintended action that leads to unwanted movement towards the floor.
This will be recorded as a numerical value of occurrence; For example if no fall events occur during the follow up period the the primary outcome measure will be reported as 0.
Similarly if a participant has 4 fall events during the follow up period the primary outcome measure will be reported as 4.
The minimum value will be 0 representing no fall events. Primary outcome values trending closer to 0 will be deemed a better outcome with 0 being the best.
There is no defined maximum value but values trending away from 0 will be treated as a worse outcome.
Measured: Recorded at day 180.
Secondary outcomes (8)
Timed up and go test (TUG test)
Total time taken for a participant to stand from a seated position walk forward 3 metres, turn around a marker, walk back towards the chair for 3 metres and sit back on the chair. Measured in seconds.
A TUG test time of less than or equal to 13 seconds will be considered as a better outcome and a TUG test time of greater than 13 seconds will be considered a worse outcome.
Measured: Completed at Day 1 and at the 6 months follow up.
Thirty second sit to stand test
Measured as the total number of repetitions of an activity (standing from a seated position then sitting down again) a participant is able to complete in 30 seconds.
The minimum value is 0 which is a worse outcome and correlates with the participant unable to complete one repetition of the activity.
There is no maximum value. Values of greater than or equal to 20 will be consider a better outcome.
Measured: Completed at Day 1 and at the 6 months follow up.
2 min walk test
Total distance a participant is able to travel walking at a normal/ comfortable pace in 2 minutes. Measured in metres.
The minimum value is 0 which is a worse outcome and correlates with the participant unable to move any distance within the allotted 2 minutes.
There is no maximum value. Values of greater than or equal to 160 metres will be considered a better outcome.
Measured: Completed at Day 1 and at the 6 months follow up.
Grip strength
The participant is asked to squeeze a dynamometer handle with one hand as hard as they can. The strength of their dominant and non-dominant hand measure independently. Measured in kilograms(Kg).
The minimum value is 0 which is a worse outcome and correlates with the participant with no power.
There is no maximum value. Values of greater than or equal to 20 will be consider a better outcome.
Measured: Completed at Day 1 and at the 6 months follow up.
Timed stair climb
Power generated to climb stairs. Measured in Watts (W)
This is calculated from:
The height (vertical distance) of the stairs recorded in metres (m). The weight of the participant recorded in kilograms (kg). The time taken to climb the stairs recorded in seconds (s). The force of gravity set at 9.81
Power = (weight x force of gravity x height of stairs) / time taken
Measured: Completed at Day 1 and at the 6 months follow up.
Physical activity scale for the elderly (PASE) questionnaire
A brief (5 minutes) survey designed specifically to assess physical activity in studies of persons age 65 years and older. It combines information on leisure, household and occupational activity.
It uses frequency, duration, and intensity level of activity over the previous week to assign a score, ranging from 0 to 793, with higher scores indicating greater physical activity thus a better outcome.
Measured: Completed at Day 1 and at the 6 months follow up.
Short musculoskeletal function assessment (SMFA) questionnaire
The SMFA consists of two sections: (i) 34 questions cover- ing the assessment of the patients function and (ii) 12 questions covering how bothered patients are by their symptoms.The questionnaire is designed to be completed by the patient. It asks about patient experience over the previous week. Each question is scored 1 for no problems/no difficulty/ not bothered (depending on the question) to 5 for unable to do a task/symptoms all the time/being greatly bothered.
The minimum value is 46 which is a better outcome. The maximum value is 230 which is a worse outcome.
Measured: Completed at Day 1 and at the 6 months follow up.
Previous fall event history questions
Fall events are defined as an unintended action that leads to loss of balance or an unintended action that leads to unwanted movement towards the floor.
This will be recorded as a numerical value of occurrence.
Participants will be asked to answer how many fall events they have had prior to the start of the study:
- In the last week
- In the last month
- In the last 3 months
- In the last 6 months
The minimum value will be 0 representing no fall events. Primary outcome values trending closer to 0 will be deemed a better outcome with 0 being the best.
There is no defined maximum value but values trending away from 0 will be treated as a worse outcome.
Measured: Completed at Day1.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Feb 2021
- Study start1 Jun 2021 (estimated)
- Primary completion1 Oct 2022 (estimated)
- Study completion30 Oct 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Accidental FallStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- CUSH Health Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- University of Sussex
- Responsible party
- Principal investigator, Kalon Hewage, MBBS BSc MSc MRCS, CUSH Health Ltd.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04751097
- Sponsor's protocol ID
- bsms9kd3
- Acronym
- iCARE
- Status last verified
- Feb 2021
- First submitted
- 23 Oct 2020
- Last updated
- 15 Feb 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Intelligent Community Active Rehab for the Elderly Study Feasibility Study
- ClinicalTrials.gov ID
- NCT04751097
- Acronym / sponsor ID
- iCARE / bsms9kd3
- Conditions
- Accidental Fall
- Keywords
- feasibility
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- CUSH Health Ltd.Industry (pharma, biotech, devices)
- Collaborators
- University of Sussex
- Study start
- 1 Jun 2021 (estimated)
- Primary completion
- 1 Oct 2022 (estimated)
- Study completion
- 30 Oct 2022 (estimated)
- First posted
- 11 Feb 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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?
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Digital Platform | Experimental | Other: CUSH Health Digital platform |
| Routine Care | No intervention | – |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (3 listed)
- Aged over 65 years of age
- Able to give informed consent
- Able to mobilise independently or with mobility aid (walking stick, Zimmer frame etc.)
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CUSH Health Digital platformRemote mobility monitoring and physiotherapy video app | Other | Digital Platform |
Primary outcome
Total number of events fall at 1 week.
Time frame: Recorded at day 7.
Fall events are defined as an unintended action that leads to loss of balance or an unintended action that leads to unwanted movement towards the floor. This will be recorded as a numerical value of occurrence; For example if no fall events occur during the follow up period the the primary outcome measure will be reported as 0. Similarly if a participant has 4 fall events during the follow up period the primary outcome measure will be reported as 4. The minimum value will be 0 representing no fall events. Primary outcome values trending closer to 0 will be deemed a better outcome with 0 being the best. There is no defined maximum value but values trending away from 0 will be treated as a worse outcome.
Total number of events fall at 2 weeks.
Time frame: Recorded at day 14.
Fall events are defined as an unintended action that leads to loss of balance or an unintended action that leads to unwanted movement towards the floor. This will be recorded as a numerical value of occurrence; For example if no fall events occur during the follow up period the the primary outcome measure will be reported as 0. Similarly if a participant has 4 fall events during the follow up period the primary outcome measure will be reported as 4. The minimum value will be 0 representing no fall events. Primary outcome values trending closer to 0 will be deemed a better outcome with 0 being the best. There is no defined maximum value but values trending away from 0 will be treated as a worse outcome.
Total number of events fall at 1 month.
Time frame: Recorded at day 30.
Fall events are defined as an unintended action that leads to loss of balance or an unintended action that leads to unwanted movement towards the floor. This will be recorded as a numerical value of occurrence; For example if no fall events occur during the follow up period the the primary outcome measure will be reported as 0. Similarly if a participant has 4 fall events during the follow up period the primary outcome measure will be reported as 4. The minimum value will be 0 representing no fall events. Primary outcome values trending closer to 0 will be deemed a better outcome with 0 being the best. There is no defined maximum value but values trending away from 0 will be treated as a worse outcome.
Total number of events fall at 3 months.
Time frame: Recorded at day 90.
Fall events are defined as an unintended action that leads to loss of balance or an unintended action that leads to unwanted movement towards the floor. This will be recorded as a numerical value of occurrence; For example if no fall events occur during the follow up period the the primary outcome measure will be reported as 0. Similarly if a participant has 4 fall events during the follow up period the primary outcome measure will be reported as 4. The minimum value will be 0 representing no fall events. Primary outcome values trending closer to 0 will be deemed a better outcome with 0 being the best. There is no defined maximum value but values trending away from 0 will be treated as a worse outcome.
Total number of events fall at 6 months.
Time frame: Recorded at day 180.
Fall events are defined as an unintended action that leads to loss of balance or an unintended action that leads to unwanted movement towards the floor. This will be recorded as a numerical value of occurrence; For example if no fall events occur during the follow up period the the primary outcome measure will be reported as 0. Similarly if a participant has 4 fall events during the follow up period the primary outcome measure will be reported as 4. The minimum value will be 0 representing no fall events. Primary outcome values trending closer to 0 will be deemed a better outcome with 0 being the best. There is no defined maximum value but values trending away from 0 will be treated as a worse outcome.
8 secondary outcomes
Timed up and go test (TUG test)
Time frame: Completed at Day 1 and at the 6 months follow up.
Thirty second sit to stand test
Time frame: Completed at Day 1 and at the 6 months follow up.
2 min walk test
Time frame: Completed at Day 1 and at the 6 months follow up.
Grip strength
Time frame: Completed at Day 1 and at the 6 months follow up.
Timed stair climb
Time frame: Completed at Day 1 and at the 6 months follow up.
Physical activity scale for the elderly (PASE) questionnaire
Time frame: Completed at Day 1 and at the 6 months follow up.
Short musculoskeletal function assessment (SMFA) questionnaire
Time frame: Completed at Day 1 and at the 6 months follow up.
Previous fall event history questions
Time frame: Completed at Day1.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Feb 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing CUSH Health Digital platform in people with Accidental Fall, run by CUSH Health Ltd..
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 15 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Total number of events fall at 1 week. (time frame: Recorded at day 7.). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Feb 2021.