Rehab After Hip Fracture With Wearable Device

Study Overview
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Brief Summary
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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
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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 .

Official Title
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Assessing the Outcome of Rehabilitation After Hip Fracture With a Wearable Device

Conditions
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Fracture of Hip

Intervention / Treatment
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* Other: Intervention
* Other: Control


Participation Criteria
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Eligibility Criteria
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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
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Randomized controlled clinical trial
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Intervention<br>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). | Other: Intervention<br>* 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)<br>|
| Active Comparator: Control<br>Standard rehabilitation alone | Other: Control<br>* Standard rehabiliation<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| Change in function | EQ5D5L index from 0 (dead) to 1 (best imaginable health) | 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) | 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, | 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 | 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 | 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 | Through study completion, on average 3 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Fracture of hip, Postural sway, Balance, Rehabilitation, Wearable device