Clinical Trials Directory

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UnknownNCT04906265

Rehab After Hip Fracture With Wearable Device

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

Status
Unknown
Phase
N/A
Study type
Interventional
Enrollment
80 (estimated)
Sponsor
Lund University · Academic / Other
Sex
All
Age
Healthy volunteers
Not accepted

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 .

Conditions

Interventions

TypeNameDescription
OTHERInterventionThe 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)
OTHERControlStandard rehabiliation

Timeline

Start date
2021-05-01
Primary completion
2025-06-30
Completion
2025-12-31
First posted
2021-05-28
Last updated
2024-01-24

Locations

1 site across 1 country: Sweden

Source: ClinicalTrials.gov record NCT04906265. Inclusion in this directory is not an endorsement.