Rehab After Hip Fracture With Wearable Device

Fracture of Hip Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04906265
• Other study ID #: 2020-00789
• Status: Recruiting
• Phase: N/A
• Start date: May 1, 2021
• Est. completion date: December 31, 2025

Study information

• Verified date: January 2024
• Source: Lund University
• Contact: Eva Ekvall Hansson, Professor
• Phone: +46462221986
• Email: eva.ekvall-hansson[@]med.lu.se
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 .

Recruitment information / eligibility

• 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

Related Conditions & MeSH terms

• Fracture of Hip
• Fractures, Bone
• Hip Fractures

Intervention

Other:
• 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, sideway deviation during walking)
• Control
Standard rehabiliation

Locations

Country	Name	City	State
Sweden	Community Rehabilitation	Malmö

Sponsors (2)

Lead Sponsor	Collaborator
Lund University	Malmo Municipality, Sweden

Country where clinical trial is conducted

Sweden, 

Outcome

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