AmputationSmartHallwayNCT06645054
Usability of the Smart Hallway System in Clinical Setting
An observational study of Amputation and Gait Disorders, Neurologic, run by University Rehabilitation Institute, Republic of Slovenia at 1 site in Slovenia.
Trial 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 more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Amputation, Gait Disorders, Neurologic
- What is being tested?
- Standard rehabilitation, Lower-limb prosthesis and Lower-limb orthosis
- Type of treatment
- Medical device, Lifestyle or therapy programme
- How many people
- 100 participants
- Where
- 1 siteSlovenia
- Study dates
- 24 Mar 2024to Dec 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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
Who may be able to join
- 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)
Who cannot join
- severe cognitive impairment,
- not being able to walk with or without a prosthesis or orthosis.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Slovenia1 site, 1 recruiting
- Recruiting
University Rehabilitation Institute, Republic of Slovenia
Ljubljana, 1000
Helena Burger, MD, PhD, +386 1 4758443, helena.burger@ir-rs.si
About this study
Official title: 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.
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.
- Conditions
- Amputation, Gait Disorders, Neurologic
- Being tested
- Standard rehabilitation, Lower-limb prosthesis, Lower-limb orthosis
- Keywords
- Gait analysis, Computerised assessment, Rehabilitation, Lower limb loss, Prosthetics and orthotics
- Medical subject headings
- Gait Disorders, Neurologic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Standard rehabilitationBehavioural
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 prosthesisDevice
The patients from the LLL group will be fitted with an appropriate lower-limb prosthesis.
Lower-limb orthosisDevice
The patients from the LLO group will be fitted with an appropriate lower-limb orthosis.
| Study group | Role | What they receive |
|---|---|---|
| LLL | Rehabilitation patients with lower limb loss Receives: Behavioral: Standard rehabilitation; Device: Lower-limb prosthesis | |
| LLO | Rehabilitation patients fitted with a lower limb orthosis Receives: Behavioral: Standard rehabilitation; Device: Lower-limb orthosis |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Upon discharge from rehabilitation
Secondary outcomes (4)
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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: Upon admission to rehabilitation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Oct 2024
- Study start24 Mar 2024
- Primary completionDec 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AmputationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Rehabilitation Institute, Republic of Slovenia
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Helena Burger, MD, PhD, Principal investigator, University Rehabilitation Institute, Republic of Slovenia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06645054
- Sponsor's protocol ID
- URIS202404
- Acronym
- SmartHallway
- Status last verified
- Oct 2026
- First submitted
- 11 Oct 2024
- Last updated
- 30 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 30 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Smart Hallway for Gait Assessment
- ClinicalTrials.gov ID
- NCT06645054
- Acronym / sponsor ID
- SmartHallway / URIS202404
- Conditions
- Amputation, Gait Disorders, Neurologic
- Keywords
- Gait analysis, Computerised assessment, Rehabilitation, Lower limb loss, Prosthetics and orthotics
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- University Rehabilitation Institute, Republic of SloveniaUniversity, hospital or other
- Study start
- 24 Mar 2024 (actual)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 16 Oct 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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 design
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| LLL | – | Behavioral: Standard rehabilitation, Device: Lower-limb prosthesisRehabilitation patients with lower limb loss |
| LLO | – | Behavioral: Standard rehabilitation, Device: Lower-limb orthosisRehabilitation patients fitted with a lower limb orthosis |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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
Key inclusion criteria (4 listed)
- 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)
Key exclusion criteria (2 listed)
- severe cognitive impairment,
- not being able to walk with or without a prosthesis or orthosis.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Standard rehabilitationThe 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). | Behavioural | LLL, LLO |
| Lower-limb prosthesisThe patients from the LLL group will be fitted with an appropriate lower-limb prosthesis. | Device | LLL |
| Lower-limb orthosisThe patients from the LLO group will be fitted with an appropriate lower-limb orthosis. | Device | LLO |
Primary outcome
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.
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.
4 secondary outcomes
World Health Organisation Disability Assessment Schedule
Time frame: Upon admission to rehabilitation
Activity Specific Balance Confidence Scale
Time frame: Upon admission to rehabilitation
Hospital Anxiety and Depression Scale
Time frame: Upon admission to rehabilitation
Six-minute walk test
Time frame: Upon admission to rehabilitation
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Oct 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Helena Burger, MD, PhD principal investigator
University Rehabilitation Institute, Republic of Slovenia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Amputation and Gait Disorders, Neurologic, run by University Rehabilitation Institute, Republic of Slovenia at 1 site in Slovenia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 30 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Slovenia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Metka Moharić, MD, PhD (+386 1 4758441, metka.moharic@ir-rs.si), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Smart Hallway (time frame: Upon admission to rehabilitation). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Oct 2026.