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.
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 .
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
80
The intervention comprises of standard rehabilitation and continuous measures of body positions and movements 24 hour 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)
Standard rehabiliation
Community Rehabilitation
Malmö, Sweden
RECRUITINGChange in postural sway
Medio-lateral and anterior-posterior sway measured with the IMU in mm/sec
Time frame: Baseline, through study completion, on average 3 months
Change in functional independence i everyday activities
The Barthel Index, likert scale, 6 items graded 0, 5, 10, 2 items graded 0, 5 and 2 items graded 0, 5, 10, 15. 100 highest possible score (best)
Time frame: Baseline and after study completion, on average 3 months
Change in function
EQ5D5L index from 0 (dead) to 1 (best imaginable health)
Time frame: Baseline and after study completion, on average 3 months
Change in health-related quality of life
EQ5D visual analogue scale, graded from 0 (worst health) to 100 (best health)
Time frame: Baseline and after study completion, on average 3 months
Change in functional balance
the Functional Balance test for Geriatric patients, including 4 tasks graded between 0-6,
Time frame: Baseline and after study completion, on average 3 months
Change in fear of falling
the Falls Efficacy Scale International , (22), comprising 16 questions with four possible answers
Time frame: Baseline and after study completion, on average 3 months
Satisfaction with rehabilitation
Measured with a single question if the person thinks their need of rehabilitation is provided for, with four possible answers
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Time frame: After study completion, on average 3 months
Compliance to the intervention
Measured with a single question on how much the participant has trained since the last home visit, with three possible answers
Time frame: Through study completion, on average 3 months