Fracture of Hip Clinical Trial
Official title:
Assessing the Outcome of Rehabilitation After Hip Fracture With a Wearable Device
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.
Status | Recruiting |
Enrollment | 80 |
Est. completion date | December 31, 2025 |
Est. primary completion date | June 30, 2025 |
Accepts healthy volunteers | No |
Gender | All |
Age group | N/A and older |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
Sweden | Community Rehabilitation | Malmö |
Lead Sponsor | Collaborator |
---|---|
Lund University | Malmo Municipality, Sweden |
Sweden,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Change in postural sway | Medio-lateral and anterior-posterior sway measured with the IMU in mm/sec | Baseline, through study completion, on average 3 months | |
Secondary | 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) | Baseline and after study completion, on average 3 months | |
Secondary | Change in function | EQ5D5L index from 0 (dead) to 1 (best imaginable health) | Baseline and after study completion, on average 3 months | |
Secondary | Change in health-related quality of life | EQ5D visual analogue scale, graded from 0 (worst health) to 100 (best health) | Baseline and after study completion, on average 3 months | |
Secondary | Change in functional balance | the Functional Balance test for Geriatric patients, including 4 tasks graded between 0-6, | Baseline and after study completion, on average 3 months | |
Secondary | Change in fear of falling | the Falls Efficacy Scale International , (22), comprising 16 questions with four possible answers | Baseline and after study completion, on average 3 months | |
Secondary | Satisfaction with rehabilitation | Measured with a single question if the person thinks their need of rehabilitation is provided for, with four possible answers | After study completion, on average 3 months | |
Secondary | 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 | Through study completion, on average 3 months |
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