Usability of the Smart Hallway System in Clinical Setting

NCT ID: NCT06645054

Last Updated: 2025-03-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

100 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-03-24

Study Completion Date

2025-06-30

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Amputation Gait Disorders, Neurologic

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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LLL

Rehabilitation patients with lower limb loss

Standard rehabilitation

Intervention Type 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

Intervention Type DEVICE

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

LLO

Rehabilitation patients fitted with a lower limb orthosis

Standard rehabilitation

Intervention Type 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 orthosis

Intervention Type DEVICE

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

Interventions

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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).

Intervention Type BEHAVIORAL

Lower-limb prosthesis

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

Intervention Type DEVICE

Lower-limb orthosis

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

Intervention Type DEVICE

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University Rehabilitation Institute, Republic of Slovenia

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Helena Burger, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

University Rehabilitation Institute, Republic of Slovenia

Locations

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University Rehabilitation Institute, Republic of Slovenia

Ljubljana, , Slovenia

Site Status RECRUITING

Countries

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Slovenia

Central Contacts

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Metka Moharić, MD, PhD

Role: CONTACT

+386 1 4758441

Facility Contacts

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Helena Burger, MD, PhD

Role: primary

+386 1 4758443

Other Identifiers

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URIS202404

Identifier Type: -

Identifier Source: org_study_id

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