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Clinical Trials/NCT04906265
NCT04906265
Recruiting
Not Applicable

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

Lund University1 site in 1 country80 target enrollmentMay 1, 2021
ConditionsFracture of Hip

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Fracture of Hip
Sponsor
Lund University
Enrollment
80
Locations
1
Primary Endpoint
Change in postural sway
Status
Recruiting
Last Updated
2 years ago

Overview

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 .

Registry
clinicaltrials.gov
Start Date
May 1, 2021
End Date
December 31, 2025
Last Updated
2 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Eva Ekvall-Hansson

Professor

Lund University

Eligibility Criteria

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

Outcomes

Primary Outcomes

Change in postural sway

Time Frame: Baseline, through study completion, on average 3 months

Medio-lateral and anterior-posterior sway measured with the IMU in mm/sec

Secondary Outcomes

  • Change in functional balance(Baseline and after study completion, on average 3 months)
  • Satisfaction with rehabilitation(After study completion, on average 3 months)
  • Compliance to the intervention(Through study completion, on average 3 months)
  • Change in functional independence i everyday activities(Baseline and after study completion, on average 3 months)
  • Change in function(Baseline and after study completion, on average 3 months)
  • Change in health-related quality of life(Baseline and after study completion, on average 3 months)
  • Change in fear of falling(Baseline and after study completion, on average 3 months)

Study Sites (1)

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