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CompletedNCT06645054SmartHallwayUpdated Nov 9, 2026

Usability of the Smart Hallway System in Clinical Setting

An observational study in Amputation and Gait Disorders, Neurologic, sponsored by University Rehabilitation Institute, Republic of Slovenia. Completed at 1 site in Slovenia. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-11-09.

Sponsored by University Rehabilitation Institute, Republic of Slovenia · Observational

Updated Nov 9, 2026Now CompletedPrimary completion moved+2 moreGo to Updates ↓
Study type
Observational
Model
Case-only
Time perspective
Cross-sectional
Enrollment
156
Ages
18 Years and older
Sex
All
01

Study summary

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.

Read the 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.

02

Conditions studied

  • Amputation
  • Gait Disorders, Neurologic

Keywords

  • Gait analysis
  • Computerised assessment
  • Rehabilitation
  • Lower limb loss
  • Prosthetics and orthotics
03

In context

Gait Disorders, Neurologic

346 studies on the registry are indexed under Gait Disorders, Neurologic; 54 are open to participants now.

This study's enrollment of 156 is above the median of 52 across 78 observational studies indexed under Gait Disorders, Neurologic.

Browse Gait Disorders, Neurologic studies →

Lead sponsor

University Rehabilitation Institute, Republic of Slovenia is the lead sponsor of 21 studies on the registry; 6 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
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

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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 )

Exclusion criteria

Exclusion Criteria:

  • severe cognitive impairment,
  • not being able to walk with or without a prosthesis or orthosis.
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

05

Study design

Observational model
Case-only
Time perspective
Cross-sectional
Enrollment
156 participants (actual)
Patient registry
No

Groups and cohorts

  • LLL

    Rehabilitation patients with lower limb loss

    Behavioral: Standard rehabilitation · Device: Lower-limb prosthesis

  • LLO

    Rehabilitation patients fitted with a lower limb orthosis

    Behavioral: Standard rehabilitation · Device: Lower-limb orthosis

Interventions

  • BehavioralStandard 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).

  • DeviceLower-limb prosthesis

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

  • DeviceLower-limb orthosis

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

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: Upon admission to rehabilitation

  2. 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.

    Time frame: Upon discharge from rehabilitation

Secondary outcomes

  1. 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).

    Time frame: Upon admission to rehabilitation

  2. 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).

    Time frame: Upon admission to rehabilitation

  3. 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).

    Time frame: Upon admission to rehabilitation

  4. 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).

    Time frame: Upon admission to rehabilitation

07

Study locations

1 site
08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Timeline

2 registry updates since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedDate before it movedWhere the date was before it moved

Ran from Mar 2024 to primary completion in Nov 2026, 31 months.

Primary completion moved twice since we started tracking on Sep 25, 2026: Sep 2026 → Nov 2026, last on Nov 9, 2026.

Completion moved twice since we started tracking on Sep 25, 2026: Sep 2026 → Nov 2026, last on Nov 9, 2026.

Earlier changes are on the record history on ClinicalTrials.gov ↗

How these figures are worked out, and which studies are left out of them.

Registered
Oct 11, 2024
First posted
Oct 16, 2024
StartActual
Mar 24, 2024
Primary completionActual
Nov 6, 2026was Sep 2026
CompletionActual
Nov 6, 2026was Sep 2026
Last update
Nov 9, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
Status
Recruiting→Completed
changed Nov 9, 2026
Primary completion
Sep 2026→Nov 6, 2026 (actual)
moved 2 times, Oct 30, 2026 – Nov 9, 2026
Study completion
Sep 2026→Nov 6, 2026 (actual)
moved 2 times, Oct 30, 2026 – Nov 9, 2026
Enrollment
100 (estimated)→156 (actual)
Nov 9, 2026
Show all 2 updates
  1. Nov 9, 2026
    Recruiting→Completed
    Primary completion Dec 2026→Nov 6, 2026 (now actual)
    Study completion Dec 2026→Nov 6, 2026 (now actual)
    Enrollment 100 (estimated)→156 (actual)
    + 3 other changes: verification date, contact details and site details
  2. Oct 30, 2026
    Primary completion Sep 2026→Dec 2026
    Study completion Sep 2026→Dec 2026
    + 1 other change: verification date

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT06645054
Lead sponsor
University Rehabilitation Institute, Republic of Slovenia
Responsible party
Sponsor
First posted
Oct 16, 2024
Start date
Mar 24, 2024
Primary completion
Nov 6, 2026
Completion
Nov 6, 2026
Last update
Nov 9, 2026

Study contacts

Helena Burger, MD, PhD
principal investigator · University Rehabilitation Institute, Republic of Slovenia

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Nov 2026. You cannot join it, but the record below documents what was studied.

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