NCT06700031

Brief Summary

With simple technology investigators can map how long it takes for a patient with a hip fracture to be helped and encouraged to stand and walk in the days following the injury. A small sensor on the thigh can measure advanced data regarding movement patterns. The limited research results available show that patients spend too much time lying down or sitting, which can lead to poorer recovery, complications, and an increased risk of death. The project maps the current situation in orthopedic emergency care as well as in orthopedic geriatric care, which is provided in a modern building with single rooms and private bathrooms. In addition to better understanding the significance of different care models, the project aims to present baseline data that future intervention studies can use as control material. The project will also connect the activity level of the patients during the hospital stay with ongoing rehabilitation studies in community follow-up care.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
40

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Nov 2024

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 29, 2024

Completed
23 days until next milestone

First Posted

Study publicly available on registry

November 21, 2024

Completed
1 day until next milestone

Study Start

First participant enrolled

November 22, 2024

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2025

Completed
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 31, 2026

Completed
Last Updated

November 21, 2024

Status Verified

October 1, 2024

Enrollment Period

7 months

First QC Date

October 29, 2024

Last Update Submit

November 18, 2024

Conditions

Keywords

hip fracturemobilizationrehabilitation

Outcome Measures

Primary Outcomes (1)

  • Minutes in upright position per day

    Sitting, standing or walking as measured by the IMU

    During hospital stay, an average of one week

Secondary Outcomes (9)

  • Complications within 30 days

    30 days from surgery

  • Association with type of fracture

    During hospital stay, an average of one week

  • Association with type of surgical method

    During hospital stay, an average of one week

  • Association with duration of surgery

    During hospital stay, an average of one week

  • Association with age

    During hospital stay, an average of one week

  • +4 more secondary outcomes

Interventions

A sensor, an inertial measurement unit (IMU), will be attached to the thigh when the individual is on the postoperative ward and will be worn throughout the hospital stay. The IMU measures 7.9 x 3.2 x 0.8 cm and records body positions, movements, and gait parameters.

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

People with acute hip fractures regardless of age or cognitive status. The fracture should need surgical treatment.

You may qualify if:

  • Having an acute hip fractures and being admitted to either two wards with orthopedic standard care or to one with orthogeriatric care at Skane University Hospital, Malmö

You may not qualify if:

  • Lack of standing ability prior to the fracture, defined as requiring a sling lift for transfer
  • Skin disease that prevent the sensor from being attached (dry, flaky, or sore skin, or sensitivity to adhesive)
  • Additional fractures besides the hip fracture or other injuries that reduce mobility (e.g., head or thoracic injuries)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Dept. of Orthopaedics, Skane University Hospital

Malmo, 20502, Sweden

Location

Related Publications (2)

  • Moller U O, Fange A M, J K, D S, F F, Hansson E E. Modern technology against falls - A description of the MoTFall project. Health Informatics J. 2021 Apr-Jun;27(2):14604582211011514. doi: 10.1177/14604582211011514.

  • Howell DF, Malmgren Fange A, Rogmark C, Ekvall Hansson E. Rehabilitation Outcomes Following Hip Fracture of Home-Based Exercise Interventions Using a Wearable Device-A Randomized Controlled Pilot and Feasibility Study. Int J Environ Res Public Health. 2023 Feb 10;20(4):3107. doi: 10.3390/ijerph20043107.

MeSH Terms

Conditions

Hip Fractures

Condition Hierarchy (Ancestors)

Femoral FracturesFractures, BoneWounds and InjuriesHip InjuriesLeg Injuries

Study Officials

  • Cecilia Rogmark, PhD, Professor

    Lund University

    PRINCIPAL INVESTIGATOR
  • Eva Ekvall Hansson, PhD, Professor

    Department of Health Sciences, Lund University

    STUDY CHAIR

Central Study Contacts

Cecilia Rogmark, MD, PhD

CONTACT

Therese Jönsson, PhD

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 29, 2024

First Posted

November 21, 2024

Study Start

November 22, 2024

Primary Completion

June 30, 2025

Study Completion

March 31, 2026

Last Updated

November 21, 2024

Record last verified: 2024-10

Locations