Usability of the Smart Hallway System in Clinical Setting
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorUniversity Rehabilitation Institute, Republic of Slovenia
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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)
Disqualifiers
severe cognitive impairment,
not being able to walk with or without a prosthesis or orthosis.
Trial 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
Trial design
Design model
Case-only
Time perspective
Cross-sectional
Treatments tested in this trial
Standard rehabilitation
BehavioralThe 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
DeviceThe patients from the LLL group will be fitted with an appropriate lower-limb prosthesis.
Lower-limb orthosis
DeviceThe patients from the LLO group will be fitted with an appropriate lower-limb orthosis.
Treatment groups
100 Participants
are divided into 2 treatment groupsGroup A: LLL2 interventions
Group B: LLO2 interventions
Trial outcomes
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 rehabilitation2
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 rehabilitationSecondary 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 rehabilitation2
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 rehabilitation3
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 rehabilitation4
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 rehabilitationSponsors and contacts
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Source ClinicalTrials.gov