Rehab After Hip Fracture With Wearable Device

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

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.

Study Overview

• Status: Recruiting
• Conditions: Fracture of Hip
• Intervention / Treatment: Other: Intervention; Other: Control

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 Type: Interventional
• Enrollment (Estimated): 80
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Eva Ekvall Hansson, Professor; Phone Number: +46462221986; Email: eva.ekvall-hansson@med.lu.se
• Study Contact Backup: Name: Agneta Malmgren Fänge, A professor; Email: agneta.malmgren_fange@med.lu.se

Study Locations

• Sweden
  • Malmö, Sweden, SE 211142
    • Recruiting
    • Community Rehabilitation
    • Contact: Åsa Hallén, Manager; Phone Number: +46702-075028; Email: asa.hallen@malmo.se
    • Contact: Marie Runström, Coordinator; Phone Number: +46721-739545; Email: marie.runstrom@malmo.se

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Control; Standard rehabilitation alone	Other: Control; Standard rehabiliation
Active Comparator: 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).	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)

What is the study measuring?

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 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 function	EQ5D5L index from 0 (dead) to 1 (best imaginable 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

Collaborators and Investigators

• Sponsor: Lund University
• Collaborators: Malmo Municipality, Sweden
• Investigators: Principal Investigator: Eva Ekvall Hansson, Lund University, Medical Faculty, Dep of Health Sciences

Study record dates

Study Major Dates

• Study Start (Actual): May 1, 2021
• Primary Completion (Estimated): June 30, 2025
• Study Completion (Estimated): December 31, 2025

Study Registration Dates

• First Submitted: May 7, 2021
• First Submitted That Met QC Criteria: May 24, 2021
• First Posted (Actual): May 28, 2021

Study Record Updates

• Last Update Posted (Estimated): January 24, 2024
• Last Update Submitted That Met QC Criteria: January 22, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Keywords: Rehabilitation; Balance; Wearable device; Postural sway; Fracture of hip
• Additional Relevant MeSH Terms: Wounds and Injuries; Leg Injuries; Femoral Fractures; Hip Injuries; Fractures, Bone; Hip Fractures
• Other Study ID Numbers: 2020-00789

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Charing individual data is not aloud according to Swedish law

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No