The iCARE Feasibility Study

NCT04751097 | Unknown DMC

• 1 other identifier: bsms9kd3
• Study Type: interventional
• Target: 30
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Accidental Fall

Keywords

feasibility

Outcome Measures

Primary Outcomes (5)

• 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.

  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.

  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.

  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.

  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.

  Recorded at day 180.

Secondary Outcomes (8)

• Timed up and go test (TUG test)

  Completed at Day 1 and at the 6 months follow up.

• Thirty second sit to stand test

  Completed at Day 1 and at the 6 months follow up.

• 2 min walk test

  Completed at Day 1 and at the 6 months follow up.

• Grip strength

  Completed at Day 1 and at the 6 months follow up.

• Timed stair climb

  Completed at Day 1 and at the 6 months follow up.

Study Arms (2)

Digital Platform

EXPERIMENTAL

Other: CUSH Health Digital platform

Routine Care

NO INTERVENTION

Interventions

CUSH Health Digital platform OTHER

Remote mobility monitoring and physiotherapy video app

Digital Platform

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• CUSH Health Ltd.: lead
• University of Sussex: collaborator

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director and Co-Founder Cush Health, Trauma and Orthopaedic Registrar

Study Record Dates

• First Submitted: October 23, 2020
• First Posted: February 11, 2021
• Study Start: June 1, 2021
• Primary Completion: October 1, 2022
• Study Completion: October 30, 2022
• Last Updated: February 15, 2021

Record last verified: 2021-02

Data Sharing

• IPD Sharing: Will not share