Rehab After Hip Fracture With Wearable Device

NCT04906265 | Unknown

• 1 other identifier: 2020-00789
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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.

Conditions

Fracture of Hip

Keywords

Fracture of hip; Postural sway; Balance; Rehabilitation; Wearable device

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (7)

• 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 functional balance

  Baseline and after study completion, on average 3 months

• Change in fear of falling

  Baseline and after study completion, on average 3 months

Study Arms (2)

Intervention

ACTIVE COMPARATOR

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

Control

ACTIVE COMPARATOR

Standard rehabilitation alone

Other: Control

Interventions

Intervention OTHER

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

Control OTHER

Standard rehabiliation

Control

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may not qualify if:

• 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

Sponsors & Collaborators

• Lund University: lead
• Malmo Municipality, Sweden: collaborator

Study Sites (1)

Community Rehabilitation

Malmo, SE 211142, Sweden

RECRUITING

MeSH Terms

Conditions

Hip Fractures

Interventions

Methods

Condition Hierarchy (Ancestors)

Femoral Fractures; Fractures, Bone; Wounds and Injuries; Hip Injuries; Leg Injuries

Intervention Hierarchy (Ancestors)

Investigative Techniques

Study Officials

• Eva Ekvall Hansson

  Lund University, Medical Faculty, Dep of Health Sciences

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Eva Ekvall Hansson, Professor

CONTACT

+46462221986; eva.ekvall-hansson@med.lu.se

Agneta Malmgren Fänge, A professor

CONTACT

agneta.malmgren_fange@med.lu.se

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: Randomized controlled clinical trial

Study Record Dates

• First Submitted: May 7, 2021
• First Posted: May 28, 2021
• Study Start: May 1, 2021
• Primary Completion: June 30, 2025
• Study Completion: December 31, 2025
• Last Updated: January 24, 2024

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will not share

Locations

SE (1)