Fracture of Hip
Conditions
Keywords
Fracture of hip, Postural sway, Balance, Rehabilitation, Wearable device
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 .
Interventions
OTHERIntervention
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)
OTHERControl
Standard rehabiliation
Sponsors
Malmo Municipality, Sweden
Lund University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Investigator)
Intervention model description
Randomized controlled clinical trial
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in postural sway | Baseline, through study completion, on average 3 months | Medio-lateral and anterior-posterior sway measured with the IMU in mm/sec |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in function | Baseline and after study completion, on average 3 months | EQ5D5L index from 0 (dead) to 1 (best imaginable health) |
| Change in health-related quality of life | Baseline and after study completion, on average 3 months | EQ5D visual analogue scale, graded from 0 (worst health) to 100 (best health) |
| Change in functional balance | Baseline and after study completion, on average 3 months | the Functional Balance test for Geriatric patients, including 4 tasks graded between 0-6, |
| Change in functional independence i everyday activities | Baseline and after study completion, on average 3 months | 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) |
| Satisfaction with rehabilitation | After study completion, on average 3 months | Measured with a single question if the person thinks their need of rehabilitation is provided for, with four possible answers |
| Compliance to the intervention | Through study completion, on average 3 months | Measured with a single question on how much the participant has trained since the last home visit, with three possible answers |
| Change in fear of falling | Baseline and after study completion, on average 3 months | the Falls Efficacy Scale International , (22), comprising 16 questions with four possible answers |
Countries
Sweden
Contacts
Primary ContactEva Ekvall Hansson, Professor
Backup ContactAgneta Malmgren Fänge, A professor
Outcome results
None listed