Usability of the Smart Hallway System in Clinical Setting (SmartHallway)

Smart Hallway for Gait Assessment

The aim of the study is to examine suitability of data and processed reports acquired from the Smart Hallway system for clinical settings in terms of user acceptability and accuracy for use in clinical practice.

Study Overview

• Status: Recruiting
• Conditions: Amputation; Gait Disorders, Neurologic
• Intervention / Treatment: Device: Lower-limb prosthesis; Device: Lower-limb orthosis; Behavioral: Standard rehabilitation

Detailed Description

The goal of the study is to use off-the-shelves markerless and contactless technologies and automatically digitise the person's movements as they walk through an institutional hallway. Multi-camera-based technologies can merge 2D-video into 3D-information. With an appropriate software, one can acquire data, perform the kinematic calculations and generate a report, all with minimal or no human intervention. The specific research question are whether pathological gait or walking disorders of the patients can be identified and classified based on the system's output, whether signs of depression can be classified from the the system's output, and whether the results of the 6-minute walk test can be predicted from the the system's output.

• Study Type: Observational
• Enrollment (Estimated): 100

Contacts and Locations

• Study Contact: Name: Metka Moharić, MD, PhD; Phone Number: +386 1 4758441; Email: metka.moharic@ir-rs.si

Study Locations

• Slovenia
  • Ljubljana, Slovenia, 1000
    • Recruiting
    • University Rehabilitation Institute, Republic of Slovenia
    • Contact: Helena Burger, MD, PhD; Phone Number: +386 1 4758443; Email: helena.burger@ir-rs.si

Participation Criteria

Eligibility Criteria

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

• Sampling Method: Non-Probability Sample

Study Population

Patients after lower limb loss (because of traumatic reason or disease) for the LLL group; patients fitted with lower-limb orthosis because of neurological reasons for the LLO group

Description

Inclusion Criteria:

• ability to walk at least 10 metres without help of a person,
• no severe cognitive problems (able to answer questionnaires),
• native Slovenian speakers,
• wiling to participate (signed informed consent)

Exclusion Criteria:

• severe cognitive impairment,
• not being able to walk with or without a prosthesis or orthosis.

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
LLL; Rehabilitation patients with lower limb loss	Device: Lower-limb prosthesis; The patients from the LLL group will be fitted with an appropriate lower-limb prosthesis.; Behavioral: Standard rehabilitation; The patients will receive standard rehabilitation that comprises assessment performed by a multidisciplinary team (physical-and-rehabilitation-medicine specialist physician, physiotherapist, occupational therapist, psychologist, social worker, prosthetics-and-orthotics engineer).
LLO; Rehabilitation patients fitted with a lower limb orthosis	Device: Lower-limb orthosis; The patients from the LLO group will be fitted with an appropriate lower-limb orthosis.; Behavioral: Standard rehabilitation; The patients will receive standard rehabilitation that comprises assessment performed by a multidisciplinary team (physical-and-rehabilitation-medicine specialist physician, physiotherapist, occupational therapist, psychologist, social worker, prosthetics-and-orthotics engineer).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Smart Hallway	As part of the regular clinical examination, the patients walk straight through a 7m long walkway, turn, and come back while data is collected with the Smart Hallway system. They start walking one meter outside the capture volume. The procedure is repeated five times to provide a sufficient number of walking cycles. Three-dimensional temporospatial gait features (position, joint angles, velocities, accelerations) are extracted from the acquired data.	Upon admission to rehabilitation
Falls during rehabilitation	Data on falls during rehabilitation is routinely collected and entered in the hospital information system (HIS). It will be transferred from the HIS to the study database upon the patient's discharge.	Upon discharge from rehabilitation

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
World Health Organisation Disability Assessment Schedule	The World Health Organisation Disability Assessment Schedule (WHODAS II) is a generic patient-reported outcome measure of disability that has been translated into Slovenian. It covers six life domains. The scores range from 0 to 100; higher score indicates more disability (i.e., worse outcome).	Upon admission to rehabilitation
Activity Specific Balance Confidence Scale	The Activity Specific Balance Confidence Scale (ABC) is a pathology-specific patient-reported outcome measure of balance that has been translated and validated in Slovenian. The scores range from 0 to 100; higher score indicates more confidence (i.e., better outcome).	Upon admission to rehabilitation
Hospital Anxiety and Depression Scale	The Hospital Anxiety and Depression Scale (HADS) is a patient-reported outcome measure that is used for assessing depression, which has been translated and validated in Slovenian. The scales comprises 14 items, 7 for anxiety and 7 for depression, all scored from 0 to 3, so the score range is from 0 to 21 for either anxiety or depression. Higher score means more pronounced anxiety and depression (i.e., worse outcome).	Upon admission to rehabilitation
Six-minute walk test	The Six-minute Walk Test (6MWT) is a standard test for assessing walking speed over a long distance with good and well-known metric characteristics. Longer walked distance means higher walking speed (i.e., better outcome).	Upon admission to rehabilitation

Collaborators and Investigators

• Sponsor: University Rehabilitation Institute, Republic of Slovenia
• Investigators: Principal Investigator: Helena Burger, MD, PhD, University Rehabilitation Institute, Republic of Slovenia

Study record dates

Study Major Dates

• Study Start (Actual): March 24, 2024
• Primary Completion (Estimated): June 1, 2025
• Study Completion (Estimated): June 1, 2025

Study Registration Dates

• First Submitted: October 11, 2024
• First Submitted That Met QC Criteria: October 15, 2024
• First Posted (Actual): October 16, 2024

Study Record Updates

• Last Update Posted (Actual): March 28, 2025
• Last Update Submitted That Met QC Criteria: March 24, 2025
• Last Verified: March 1, 2025

More Information

Terms related to this study

• Keywords: Rehabilitation; Gait analysis; Lower limb loss; Computerised assessment; Prosthetics and orthotics
• Additional Relevant MeSH Terms: Neurologic Manifestations; Nervous System Diseases; Gait Disorders, Neurologic
• Other Study ID Numbers: URIS202404

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

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