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NCT Number: NCT06645054

Usability of the Smart Hallway System in Clinical Setting

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

University Rehabilitation Institute, Republic of Slovenia

Ljubljana, 1000, Slovenia

Location status: Recruiting

Location contact

Helena Burger, MD, PhD

CONTACT

[email protected]

+386 1 4758443

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

standard rehabilitation

Behavioral

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).

Lower-limb prosthesis

Device

The patients from the LLL group will be fitted with an appropriate lower-limb prosthesis.

Lower-limb orthosis

Device

The patients from the LLO group will be fitted with an appropriate lower-limb orthosis.

Primary outcomes

  1. Smart Hallway

    Time frame: Upon admission to rehabilitation

    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.

  2. Falls during rehabilitation

    Time frame: Upon discharge from 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.

Secondary outcomes

  1. World Health Organisation Disability Assessment Schedule

    Time frame: Upon admission to rehabilitation

    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).

  2. Activity Specific Balance Confidence Scale

    Time frame: Upon admission to rehabilitation

    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).

  3. Hospital Anxiety and Depression Scale

    Time frame: Upon admission to rehabilitation

    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).

  4. Six-minute walk test

    Time frame: Upon admission to rehabilitation

    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).

Study contacts

Contact information is provided by the study sponsor or research team.

Metka Moharić, MD, PhD

CONTACT

[email protected]

+386 1 4758441

Sponsors and collaborators

Lead sponsor

University Rehabilitation Institute, Republic of Slovenia

Other

Registry information

Official study title

Smart Hallway for Gait Assessment

Acronym: SmartHallway

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Oct 16, 2024
Registry last updated
Jun 15, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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