StrokeBALANCESINCT03285919
Perturbed-balance Training During Treadmill Walking for Stroke Subjects
A study testing Balance Assessment Robot (BAR™) in people with Stroke, run by University Rehabilitation Institute, Republic of Slovenia at 1 site in Slovenia.
Trial summary
A control and a post-stroke subject with right-side chronic hemiparesis were studied. The post-stroke subject underwent 30 sessions of balance-perturbed training while walking on an instrumented treadmill where the Balance Assessment Robot (BAR™) randomly delivered pushes to pelvis in various directions at various… Read more about this study
- Who is it for?
- Any age, men onlyHealthy volunteers can take part
- Conditions the study is for
- Stroke
- What is being tested?
- Balance Assessment Robot (BAR™)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2 participants
- Where
- 1 siteSlovenia
- Study dates
- 5 Dec 2016to 2 Jun 2017
- 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 Any age
- Men only
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Case: community-dwelling, high-functioning stroke survivor
- Control: healthy volunteer, height- and weight-matched to the Case
Who cannot join
- any disease or injury affecting cognition
- any disease or injury affecting balance or gait
Trial locations and contacts
1 site in 1 country.
Slovenia1 site
University Rehabilitation Institute, Republic of Slovenia
Ljubljana, 1000
About this study
Official title: Feasibility of Perturbed-balance Training During Treadmill Walking in a High-functioning Chronic Stroke Subject: a Case-control Study
A control and a post-stroke subject with right-side chronic hemiparesis were studied. The post-stroke subject underwent 30 sessions of balance-perturbed training while walking on an instrumented treadmill where the Balance Assessment Robot (BAR™) randomly delivered pushes to pelvis in various directions at various speeds and at various perturbation amplitudes. The investigators assessed kinematics, kinetics, electromiography and spatio-temporal responses to outward-directed perturbations commencing either at foot contact of the left or the right leg.
Read the detailed description
For a detailed description of the study, see the Arms and Interventions section.
- Conditions
- Stroke
- Being tested
- Balance Assessment Robot (BAR™)
- Keywords
- perturbed walking, stepping response
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Balance Assessment Robot (BAR™)Device
The BAR™ has got six degrees of freedom (DOF) that interface to the pelvis of a walking subject. Five DOFs (translation of pelvis in sagittal, lateral and vertical directions; pelvic rotation and pelvic list) are actuated and admittance-controlled, providing transparent haptic interaction with negligible power transfer; the remaining DOF (pelvic tilt) is passive. The BAR™ is capable of delivering perturbations in the directions forward/backward and left/right, but for the purpose of this study only "outward" perturbations in the frontal plane were considered.
| Study group | Role | What they receive |
|---|---|---|
| Case - stroke survivor | Experimental | Stroke survivor, 6mon post stroke resulting in right-sided hemiparesis, 53yrs old, had completed a 2mon rehabilitation program prior to the study. He underwent 30 training sessions with the Balance Assessment Robot (BAR™) within a 10-week period, each consisting of 10-15min of unperturbed treadmill and 30-45min of perturbation training. Perturbations were delivered in the forward, backward, left and right direction, occurring every 6sec, at the left leg initial contact and the right leg initial contact. Two training sessions were spent to determine adequate treadmill speed (0.4m/s) and perturbation amplitude (60N), followed by the first assessment session. After the last training session, assessment was repeated using the same parameters plus 90N perturbation amplitude. Receives: Device: Balance Assessment Robot (BAR™) |
| Control - matched healthy subject | Active comparator | Healthy male, height- and weight-matched to the Case. He was assessed according to the same protocol as the Case using the Balance Assessment Robot (BAR™) at perturbation amplitudes 60 and 90 N. Receives: Device: Balance Assessment Robot (BAR™) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in centre of mass of the Case
For the purpose of qualitative assessment of kinematics and kinetics
Measured: Assessment at session no. 3 (during week 1) and session no. 30 (during week 10)
Change in centre of pressure of the Case
For the purpose of qualitative assessment of kinematics and kinetics
Measured: Assessment at session no. 3 (during week 1) and session no. 30 (during week 10)
Change in ground reaction force of the Case
For the purpose of qualitative assessment of kinematics and kinetics
Measured: Assessment at session no. 3 (during week 1) and session no. 30 (during week 10)
Secondary outcomes (3)
Centre of mass of the Control
For the purpose of qualitative assessment of spatio-temporal characteristics of stepping
Measured: During the only session (i.e., session 1 on day 1)
Centre of pressure of the Control
For the purpose of qualitative assessment of spatio-temporal characteristics of stepping
Measured: During the only session (i.e., session 1 on day 1)
Ground reaction force of the Control
For the purpose of qualitative assessment of spatio-temporal characteristics of stepping
Measured: During the only session (i.e., session 1 on day 1)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Sep 2017
- Study start5 Dec 2016
- Primary completion2 Jun 2017
- Study completion2 Jun 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 2 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Rehabilitation Institute, Republic of Slovenia
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Zlatko Matjačić, PhD, Principal investigator, University Rehabilitation Institute, Republic of Slovenia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03285919
- Sponsor's protocol ID
- URIS201703
- Acronym
- BALANCESI
- Status last verified
- Sep 2017
- First submitted
- 5 Sep 2017
- Last updated
- 18 Sep 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Olensek A, Zadravec M, Matjacic Z. A novel robot for imposing perturbations during overground walking: mechanism, control and normative stepping responses. J Neuroeng Rehabil. 2016 Jun 11;13(1):55. doi: 10.1186/s12984-016-0160-7.
PubMed 27287551Matjacic Z, Zadravec M, Olensek A. Feasibility of robot-based perturbed-balance training during treadmill walking in a high-functioning chronic stroke subject: a case-control study. J Neuroeng Rehabil. 2018 Apr 11;15(1):32. doi: 10.1186/s12984-018-0373-z.
PubMed 29642921
Study at a glance
From the registry record, last updated by the sponsor on 18 Sep 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility of Perturbed-balance Training During Treadmill Walking in a High-functioning Chronic Stroke Subject: a Case-control Study
- ClinicalTrials.gov ID
- NCT03285919
- Acronym / sponsor ID
- BALANCESI / URIS201703
- Conditions
- Stroke
- Keywords
- perturbed walking, stepping response
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 2 participants (actual)
- Lead sponsor
- University Rehabilitation Institute, Republic of SloveniaUniversity, hospital or other
- Study start
- 5 Dec 2016 (actual)
- Primary completion
- 2 Jun 2017 (actual)
- Study completion
- 2 Jun 2017 (actual)
- First posted
- 18 Sep 2017 (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.
A control and a post-stroke subject with right-side chronic hemiparesis were studied. The post-stroke subject underwent 30 sessions of balance-perturbed training while walking on an instrumented treadmill where the Balance Assessment Robot (BAR™) randomly delivered pushes to pelvis in various directions at various speeds and at various perturbation amplitudes. The investigators assessed kinematics, kinetics, electromiography and spatio-temporal responses to outward-directed perturbations commencing either at foot contact of the left or the right leg.
Detailed description
For a detailed description of the study, see the Arms and Interventions section.
Study design
- Primary purpose
- Device feasibility
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Case - stroke survivor | Experimental | Device: Balance Assessment Robot (BAR™)Stroke survivor, 6mon post stroke resulting in right-sided hemiparesis, 53yrs old, had completed a 2mon rehabilitation program prior to the study. He underwent 30 training sessions with the Balance Assessment Robot (BAR™) within a 10-week period, each consisting of 10-15min of unperturbed treadmill and 30-45min of perturbation training. Perturbations were delivered in the forward, backward, left and right direction, occurring every 6sec, at the left leg initial contact and the right leg initial contact. Two training sessions were spent to determine adequate treadmill speed (0.4m/s) and perturbation amplitude (60N), followed by the first assessment session. After the last training session, assessment was repeated using the same parameters plus 90N perturbation amplitude. |
| Control - matched healthy subject | Active comparator | Device: Balance Assessment Robot (BAR™)Healthy male, height- and weight-matched to the Case. He was assessed according to the same protocol as the Case using the Balance Assessment Robot (BAR™) at perturbation amplitudes 60 and 90 N. |
Who may qualify
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- Case: community-dwelling, high-functioning stroke survivor
- Control: healthy volunteer, height- and weight-matched to the Case
Key exclusion criteria (2 listed)
- any disease or injury affecting cognition
- any disease or injury affecting balance or gait
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 |
|---|---|---|
| Balance Assessment Robot (BAR™)The BAR™ has got six degrees of freedom (DOF) that interface to the pelvis of a walking subject. Five DOFs (translation of pelvis in sagittal, lateral and vertical directions; pelvic rotation and pelvic list) are actuated and admittance-controlled, providing transparent haptic interaction with negligible power transfer; the remaining DOF (pelvic tilt) is passive. The BAR™ is capable of delivering perturbations in the directions forward/backward and left/right, but for the purpose of this study only "outward" perturbations in the frontal plane were considered. | Device | Case - stroke survivor, Control - matched healthy subject |
Primary outcome
Change in centre of mass of the Case
Time frame: Assessment at session no. 3 (during week 1) and session no. 30 (during week 10)
For the purpose of qualitative assessment of kinematics and kinetics
Change in centre of pressure of the Case
Time frame: Assessment at session no. 3 (during week 1) and session no. 30 (during week 10)
For the purpose of qualitative assessment of kinematics and kinetics
Change in ground reaction force of the Case
Time frame: Assessment at session no. 3 (during week 1) and session no. 30 (during week 10)
For the purpose of qualitative assessment of kinematics and kinetics
3 secondary outcomes
Centre of mass of the Control
Time frame: During the only session (i.e., session 1 on day 1)
Centre of pressure of the Control
Time frame: During the only session (i.e., session 1 on day 1)
Ground reaction force of the Control
Time frame: During the only session (i.e., session 1 on day 1)
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 18 Sep 2017.
- Background: PubMed 27287551Olensek A, Zadravec M, Matjacic Z. A novel robot for imposing perturbations during overground walking: mechanism, control and normative stepping responses. J Neuroeng Rehabil. 2016 Jun 11;13(1):55. doi: 10.1186/s12984-016-0160-7.
- Derived from this study: PubMed 29642921Matjacic Z, Zadravec M, Olensek A. Feasibility of robot-based perturbed-balance training during treadmill walking in a high-functioning chronic stroke subject: a case-control study. J Neuroeng Rehabil. 2018 Apr 11;15(1):32. doi: 10.1186/s12984-018-0373-z.
- 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. This study is not recruiting at the moment.
Zlatko Matjačić, 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 Balance Assessment Robot (BAR™) 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 2 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: finished, as of the sponsor's last update on 18 Sep 2017. 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 centre of mass of the Case (time frame: Assessment at session no. 3 (during week 1) and session no. 30 (during week 10)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03285919, which also lists 2 linked publications.
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 18 Sep 2017.