Rehab After Hip Fracture With Wearable Device

Not Applicable

Recruiting

• Conditions: Fracture of Hip
• Interventions: Other: Control; Other: Intervention

• Registration Number: NCT04906265
• Lead Sponsor: Lund University

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 .

Study Timeline

• Study Start: 2021-05-01
• Study First Submitted: 2021-05-07
• Study First Submitted QC: 2021-05-24
• Study First Posted: 2021-05-28
• Status Verified: 2024-01
• Last Update Submitted: 2024-01-22
• Last Update Posted: 2024-01-24
• Primary Completion: 2025-06-30
• Study Completion: 2025-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 80

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control	Control	Standard rehabilitation alone
Intervention	Intervention	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).

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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,
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 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)
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 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

Trial Locations

Locations (1)

Community Rehabilitation; 🇸🇪 Malmö, Sweden