StrokeBARTNCT03782948
Effect of Robotised Gait Training on Dynamic Balance, Symmetry and Push-off in Persons After Stroke
A study testing Standard gait training on BART without pelvic perturbations and Robotised gait training with BART with pelvic perturbations in people with Stroke, run by University Rehabilitation Institute, Republic of Slovenia at 1 site in Slovenia.
Trial summary
Rehabilitation robotics is increasingly used because it enables the patients to practice a wide array of movements. Dynamic balance training is essential for gait rehabilitation and robotised devices enhance repeatability, objectivity and precision of such training combined with monitoring and recording of kinematic… Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Stroke
- What is being tested?
- Standard gait training on BART without pelvic perturbations and Robotised gait training with BART with pelvic perturbations
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteSlovenia
- Study dates
- 31 Jan 2019to 31 Dec 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subacute phase after first ischaemic or haemorrhagic stroke (less than 6 months after stroke);
- Limb hemiparesis;
- Ability to walk independently (FAC 6) or with assistance (FAC 5) on flat and uneven surfaces, stairs and slopes;
- Adequate cardiovascular ability (NYHA 1).
Who cannot join
- Degenerative process or postoperative condition on lower-limb joints that would hinder gait;
- Associated neurological disease;
- Decreased cognitive ability (KPSS < 25).
Trial locations and contacts
1 site in 1 country.
Slovenia1 site
University Rehabilitation Institute, Republic of Slovenia
Ljubljana, 1000
About this study
Rehabilitation robotics is increasingly used because it enables the patients to practice a wide array of movements. Dynamic balance training is essential for gait rehabilitation and robotised devices enhance repeatability, objectivity and precision of such training combined with monitoring and recording of kinematic and kinetic data. The aim of the study is to explore the effect of robot-assisted gait training on dynamic balance, symmetry and take-off in patients after stroke. The investigators will conduct a randomised intervention study where one group will receive visual feedback on gait status and the other group will receive kinetically-assisted training using a robotised device in addition to the visual feedback.
Read the detailed description
Gait training will start 3 weeks after admission to inpatient rehabilitation. It will last for 3 weeks, 5 times per week, 30 minutes per day. The first few sessions with the robotic device will serve to familiarise the patient with the BART device and training conditions. Further details are described in the Arms and Interventions section.
- Conditions
- Stroke
- Being tested
- Standard gait training on BART without pelvic perturbations, Robotised gait training with BART with pelvic perturbations
- Keywords
- gait training, dynamic balance, gait symmetry, rehabilitation robotics
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Standard gait training on BART without pelvic perturbationsDevice
The Balance Assisted Robot on Treadmill (BART) enables various types of gait training on treadmill with visual feedback. It interfaces to the pelvis of the walking subject in an actuated and admittance-controlled manner, thus providing transparent haptic interaction with negligible power transfer.
Robotised gait training with BART with pelvic perturbationsDevice
In addition to the standard gait training, the BART will deliver perturbations in the forward/backward and left/right direction.
| Study group | Role | What they receive |
|---|---|---|
| Controls | Active comparator | In each session, the group will undergo standard gait training on BART without pelvic perturbations, i.e.,
* walk a virtual track on the BART without pelvic perturbations (i.e., the pelvic brace of the BART device will be set to follow the patient's motion) for 10 minutes;
* practise gait symmetry and take-off using visual feedback without pelvic perturbations in two 10-minute sessions. Receives: Device: Standard gait training on BART without pelvic perturbations |
| Experimental | Experimental | In each session, the group will undergo robotised gait training with BART with pelvic perturbations, i.e.,
* walk a virtual track on the BART with pelvic perturbations during virtual uphill walk and virtual curved walk for 10 minutes;
* practise gait symmetry and take-off using visual feedback with pelvic perturbations for 10 minutes;
* practise dynamic gait balance using pelvic perturbations during treadmill walking for 10 minutes. Receives: Device: Robotised gait training with BART with pelvic perturbations |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in postural stability during walking
Assessed using the Functional Gait Assessment (FGA) scale. The scale scores range from 0 to 30, with higher scores indicating less impairment.
Measured: Assessment before and after the 3-week training programme
Secondary outcomes (6)
Change in functional ambulation category
Assessed using the Functional Ambulation Categories (FAC) scale. The FAC is a 6-point scale (0-5), with higher category indicating better walking ability.
Measured: Assessment before and after the 3-week training programme
Change in functional independence
Assessed using the Motor subscale of the Functional Independence Measure (FIM). FIM Motor subscale scores range from 13 to 91, with higher scores indicating better functional independence.
Measured: Assessment before and after the 3-week training programme
Change in fall-risk related mobility
Assessed using the Timed Up and Go (TUG) test. Longer TUG times indicate worse mobility (and thus higher fall risk).
Measured: Assessment before and after the 3-week training programme
Change in ability to change directions while stepping
Assessed using the Four Square Step Test (FSST). The FSST is timed, with longer times indicating worse ability.
Measured: Assessment before and after the 3-week training programme
Change in walking speed over a short distance
Assessed using the 10 Meter Walk Test (10MWT)
Measured: Assessment before and after the 3-week training programme
Change in walking speed over a long distance
Assessed using the 6 Minute Walk Test (6MWT)
Measured: Assessment before and after the 3-week training programme
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Dec 2018
- Study start31 Jan 2019
- Primary completion31 Dec 2020
- Study completion31 Dec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for StrokeStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Device feasibility
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Rehabilitation Institute, Republic of Slovenia
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Matjaž Zadravec, PhD, Principal investigator, University Rehabilitation Institute, Republic of Slovenia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03782948
- Sponsor's protocol ID
- URIS201802
- Acronym
- BART
- Status last verified
- Feb 2021
- First submitted
- 18 Dec 2018
- Last updated
- 15 Feb 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Robotised Gait Training on Dynamic Balance, Symmetry and Push-off in Persons After Stroke
- ClinicalTrials.gov ID
- NCT03782948
- Acronym / sponsor ID
- BART / URIS201802
- Conditions
- Stroke
- Keywords
- gait training, dynamic balance, gait symmetry, rehabilitation robotics
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- University Rehabilitation Institute, Republic of SloveniaUniversity, hospital or other
- Study start
- 31 Jan 2019 (actual)
- Primary completion
- 31 Dec 2020 (actual)
- Study completion
- 31 Dec 2020 (actual)
- First posted
- 20 Dec 2018 (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.
Rehabilitation robotics is increasingly used because it enables the patients to practice a wide array of movements. Dynamic balance training is essential for gait rehabilitation and robotised devices enhance repeatability, objectivity and precision of such training combined with monitoring and recording of kinematic and kinetic data. The aim of the study is to explore the effect of robot-assisted gait training on dynamic balance, symmetry and take-off in patients after stroke. The investigators will conduct a randomised intervention study where one group will receive visual feedback on gait status and the other group will receive kinetically-assisted training using a robotised device in addition to the visual feedback.
Detailed description
Gait training will start 3 weeks after admission to inpatient rehabilitation. It will last for 3 weeks, 5 times per week, 30 minutes per day. The first few sessions with the robotic device will serve to familiarise the patient with the BART device and training conditions. Further details are described in the Arms and Interventions section.
Study design
- Primary purpose
- Device feasibility
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Controls | Active comparator | Device: Standard gait training on BART without pelvic perturbationsIn each session, the group will undergo standard gait training on BART without pelvic perturbations, i.e., * walk a virtual track on the BART without pelvic perturbations (i.e., the pelvic brace of the BART device will be set to follow the patient's motion) for 10 minutes; * practise gait symmetry and take-off using visual feedback without pelvic perturbations in two 10-minute sessions. |
| Experimental | Experimental | Device: Robotised gait training with BART with pelvic perturbationsIn each session, the group will undergo robotised gait training with BART with pelvic perturbations, i.e., * walk a virtual track on the BART with pelvic perturbations during virtual uphill walk and virtual curved walk for 10 minutes; * practise gait symmetry and take-off using visual feedback with pelvic perturbations for 10 minutes; * practise dynamic gait balance using pelvic perturbations during treadmill walking for 10 minutes. |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Subacute phase after first ischaemic or haemorrhagic stroke (less than 6 months after stroke);
- Limb hemiparesis;
- Ability to walk independently (FAC 6) or with assistance (FAC 5) on flat and uneven surfaces, stairs and slopes;
- Adequate cardiovascular ability (NYHA 1).
Key exclusion criteria (3 listed)
- Degenerative process or postoperative condition on lower-limb joints that would hinder gait;
- Associated neurological disease;
- Decreased cognitive ability (KPSS < 25).
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 gait training on BART without pelvic perturbationsThe Balance Assisted Robot on Treadmill (BART) enables various types of gait training on treadmill with visual feedback. It interfaces to the pelvis of the walking subject in an actuated and admittance-controlled manner, thus providing transparent haptic interaction with negligible power transfer. | Device | Controls |
| Robotised gait training with BART with pelvic perturbationsIn addition to the standard gait training, the BART will deliver perturbations in the forward/backward and left/right direction. | Device | Experimental |
Primary outcome
Change in postural stability during walking
Time frame: Assessment before and after the 3-week training programme
Assessed using the Functional Gait Assessment (FGA) scale. The scale scores range from 0 to 30, with higher scores indicating less impairment.
6 secondary outcomes
Change in functional ambulation category
Time frame: Assessment before and after the 3-week training programme
Change in functional independence
Time frame: Assessment before and after the 3-week training programme
Change in fall-risk related mobility
Time frame: Assessment before and after the 3-week training programme
Change in ability to change directions while stepping
Time frame: Assessment before and after the 3-week training programme
Change in walking speed over a short distance
Time frame: Assessment before and after the 3-week training programme
Change in walking speed over a long distance
Time frame: Assessment before and after the 3-week training programme
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Feb 2021.
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Web-Based Tele-Rehabilitation Using Action Observation and Mirror Therapy for Subacute Stroke: A Randomized Controlled Trial
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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. This study is not recruiting at the moment.
Matjaž Zadravec, 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?
A study testing Standard gait training on BART without pelvic perturbations and Robotised gait training with BART with pelvic perturbations in people with Stroke, 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 3 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: finished, as of the sponsor's last update on 15 Feb 2021. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in postural stability during walking (time frame: Assessment before and after the 3-week training programme). 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 15 Feb 2021.