Clinical trial NCT04906265: Rehab After Hip Fracture With Wearable Device
Official title: Assessing the Outcome of Rehabilitation After Hip Fracture With a Wearable Device
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Fracture of Hip
Keywords: Fracture of hip
Postural sway
Balance
Rehabilitation
Wearable device
Lead sponsor: Lund University
Sponsor class: OTHER
Collaborators: name: Malmo Municipality, Sweden
First posted: 2021-05-28
Enrollment: 80
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized controlled clinical trial
Primary purpose: TREATMENT

Brief summary: A randomized control trial, including two intervention arms with different methods for rehabilitation after hip fracture, conducted among persons with the need of rehabilitation in their own home.

Detailed description: The increase of the aging population challenges health care providers. Fragility, oste-oporosis, and impaired balance are some major risk factors for hip fracture, an injury causing morbidity, mortality, and loss of independent life. This study aims to study if adding continuous measures of body positions and movements 24 hours a day with an Inertial Measurement Unit (IMU) can, compared to standard rehabilitation alone, optimize rehabilitation after hip fracture. The study is designed as a randomized controlled trial. Patients with hip fracture that require rehabilitation at home, will be invited to participate in the study. Those who accept to participate will randomly be assigned to intervention- or control group. The intervention comprises standard rehabilitation and continuous measures of body positions and movements 24 hours a day with an IMU. Standard rehabilitation comprises of home-visits by a PT, where an individualized rehabilitation plan is outlined together with the patient. The plan includes individually tailored functional exercises. The plan also includes individually tailored walking exercises, indoor and outdoor when possible. At each home visit, the PT provides feedback to the participant based on the data from the IMU, i.e. body positions (time spent in sitting, standing, lying down) and body movements (steps per day, step length, walking speed, sideway deviation during walking). The control group receives standard rehabilitation only. The primary outcome is balance, in terms of postural sway measured with the IMU, and functional balance measured with the Functional Balance test for Geriatric patients, secondary outcomes are health-related quality of life, measured with the EQ5D, functional independence in everyday activities, measured with the Barthel Index, fear of falling, measured with the Falls Efficacy Scale International, satisfaction with rehabilitation, measured with a single question, and compliance to the intervention .

Eligibility criteria: Inclusion Criteria:

* patients with a hip fracture, living in Malmö, and who are unable to visit a rehabilitation facility and therefore request treatment at home. Another inclusion criterion is the ability to read and understand the Swedish language or the ability to understand information through an interpreter.

Exclusion Criteria:

* the presence of major neurological diseases that have an impact on balance and walk-ing ability; a diagnosed cognitive disease, or moderate to severe cognitive impairment as assessed by a physiotherapist

Primary outcomes:
measure: Change in postural sway
timeFrame: Baseline, through study completion, on average 3 months
Secondary outcomes:
measure: Change in functional independence i everyday activities
timeFrame: Baseline and after study completion, on average 3 months
measure: Change in function
timeFrame: Baseline and after study completion, on average 3 months
measure: Change in health-related quality of life
timeFrame: Baseline and after study completion, on average 3 months
measure: Change in functional balance
timeFrame: Baseline and after study completion, on average 3 months
measure: Change in fear of falling
timeFrame: Baseline and after study completion, on average 3 months
measure: Satisfaction with rehabilitation
timeFrame: After study completion, on average 3 months
measure: Compliance to the intervention
timeFrame: Through study completion, on average 3 months
Other outcomes:
Locations:
city: Malmö
country: Sweden
facility: Community Rehabilitation
Study officials:
affiliation: Lund University, Medical Faculty, Dep of Health Sciences
name: Eva Ekvall Hansson
role: PRINCIPAL_INVESTIGATOR
References: