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Rehab After Hip Fracture With Wearable Device

Primary Purpose

Fracture of Hip

Status
Recruiting
Phase
Not Applicable
Locations
Sweden
Study Type
Interventional
Intervention
Intervention
Control
Sponsored by
Lund University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Fracture of Hip focused on measuring Fracture of hip, Postural sway, Balance, Rehabilitation, Wearable device

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Community RehabilitationRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Intervention

Control

Arm Description

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).

Standard rehabilitation alone

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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)
Change in function
EQ5D5L index from 0 (dead) to 1 (best imaginable health)
Change in health-related quality of life
EQ5D visual analogue scale, graded from 0 (worst health) to 100 (best health)
Change in functional balance
the Functional Balance test for Geriatric patients, including 4 tasks graded between 0-6,
Change in fear of falling
the Falls Efficacy Scale International , (22), comprising 16 questions with four possible answers
Satisfaction with rehabilitation
Measured with a single question if the person thinks their need of rehabilitation is provided for, with four possible answers
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

Full Information

First Posted
May 7, 2021
Last Updated
April 6, 2023
Sponsor
Lund University
Collaborators
Malmo Municipality, Sweden
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1. Study Identification

Unique Protocol Identification Number
NCT04906265
Brief Title
Rehab After Hip Fracture With Wearable Device
Official Title
Assessing the Outcome of Rehabilitation After Hip Fracture With a Wearable Device
Study Type
Interventional

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Recruiting
Study Start Date
May 1, 2021 (Actual)
Primary Completion Date
June 30, 2025 (Anticipated)
Study Completion Date
December 31, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Lund University
Collaborators
Malmo Municipality, Sweden

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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 .

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Fracture of Hip
Keywords
Fracture of hip, Postural sway, Balance, Rehabilitation, Wearable device

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Randomized controlled clinical trial
Masking
Investigator
Allocation
Randomized
Enrollment
80 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Intervention
Arm Type
Active Comparator
Arm Description
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).
Arm Title
Control
Arm Type
Active Comparator
Arm Description
Standard rehabilitation alone
Intervention Type
Other
Intervention Name(s)
Intervention
Intervention Description
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)
Intervention Type
Other
Intervention Name(s)
Control
Intervention Description
Standard rehabiliation
Primary Outcome Measure Information:
Title
Change in postural sway
Description
Medio-lateral and anterior-posterior sway measured with the IMU in mm/sec
Time Frame
Baseline, through study completion, on average 3 months
Secondary Outcome Measure Information:
Title
Change in functional independence i everyday activities
Description
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)
Time Frame
Baseline and after study completion, on average 3 months
Title
Change in function
Description
EQ5D5L index from 0 (dead) to 1 (best imaginable health)
Time Frame
Baseline and after study completion, on average 3 months
Title
Change in health-related quality of life
Description
EQ5D visual analogue scale, graded from 0 (worst health) to 100 (best health)
Time Frame
Baseline and after study completion, on average 3 months
Title
Change in functional balance
Description
the Functional Balance test for Geriatric patients, including 4 tasks graded between 0-6,
Time Frame
Baseline and after study completion, on average 3 months
Title
Change in fear of falling
Description
the Falls Efficacy Scale International , (22), comprising 16 questions with four possible answers
Time Frame
Baseline and after study completion, on average 3 months
Title
Satisfaction with rehabilitation
Description
Measured with a single question if the person thinks their need of rehabilitation is provided for, with four possible answers
Time Frame
After study completion, on average 3 months
Title
Compliance to the intervention
Description
Measured with a single question on how much the participant has trained since the last home visit, with three possible answers
Time Frame
Through study completion, on average 3 months

10. Eligibility

Sex
All
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Eva Ekvall Hansson, Professor
Phone
+46462221986
Email
eva.ekvall-hansson@med.lu.se
First Name & Middle Initial & Last Name or Official Title & Degree
Agneta Malmgren Fänge, A professor
Email
agneta.malmgren_fange@med.lu.se
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Eva Ekvall Hansson
Organizational Affiliation
Lund University, Medical Faculty, Dep of Health Sciences
Official's Role
Principal Investigator
Facility Information:
Facility Name
Community Rehabilitation
City
Malmö
ZIP/Postal Code
SE 211142
Country
Sweden
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Åsa Hallén, Manager
Phone
+46702-075028
Email
asa.hallen@malmo.se
First Name & Middle Initial & Last Name & Degree
Marie Runström, Coordinator
Phone
+46721-739545
Email
marie.runstrom@malmo.se

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
Charing individual data is not aloud according to Swedish law

Learn more about this trial

Rehab After Hip Fracture With Wearable Device

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