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Perturbed-balance Training During Treadmill Walking for Stroke Subjects (BALANCESI)

Primary Purpose

Stroke

Status

Completed

Phase

Not Applicable

Locations

Slovenia

Study Type

Interventional

Intervention

Balance Assessment Robot (BAR™)

About this trial

This is an interventional device feasibility trial for Stroke focused on measuring perturbed walking, stepping response

Eligibility Criteria

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Inclusion criteria:

Case: community-dwelling, high-functioning stroke survivor
Control: healthy volunteer, height- and weight-matched to the Case

Exclusion criteria:

any disease or injury affecting cognition
any disease or injury affecting balance or gait

Sites / Locations

University Rehabilitation Institute, Republic of Slovenia

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Case - stroke survivor

Control - matched healthy subject

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Change in centre of mass of the Case

For the purpose of qualitative assessment of kinematics and kinetics

Change in centre of pressure of the Case

For the purpose of qualitative assessment of kinematics and kinetics

Change in ground reaction force of the Case

For the purpose of qualitative assessment of kinematics and kinetics

Secondary Outcome Measures

Centre of mass of the Control

For the purpose of qualitative assessment of spatio-temporal characteristics of stepping

Centre of pressure of the Control

For the purpose of qualitative assessment of spatio-temporal characteristics of stepping

Ground reaction force of the Control

For the purpose of qualitative assessment of spatio-temporal characteristics of stepping

Full Information

NCT ID

NCT03285919

First Posted

September 5, 2017

Last Updated

September 15, 2017

Sponsor

University Rehabilitation Institute, Republic of Slovenia

1. Study Identification

Unique Protocol Identification Number

NCT03285919

Brief Title

Perturbed-balance Training During Treadmill Walking for Stroke Subjects

Acronym

BALANCESI

Official Title

Feasibility of Perturbed-balance Training During Treadmill Walking in a High-functioning Chronic Stroke Subject: a Case-control Study

Study Type

Interventional

2. Study Status

Record Verification Date

September 2017

Overall Recruitment Status

Completed

Study Start Date

December 5, 2016 (Actual)

Primary Completion Date

June 2, 2017 (Actual)

Study Completion Date

June 2, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

University Rehabilitation Institute, Republic of Slovenia

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

Brief 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 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Stroke

Keywords

perturbed walking, stepping response

7. Study Design

Primary Purpose

Device Feasibility

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

2 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Case - stroke survivor

Arm Type

Experimental

Arm Description

Arm Title

Control - matched healthy subject

Arm Type

Active Comparator

Arm Description

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.

Intervention Type

Device

Intervention Name(s)

Balance Assessment Robot (BAR™)

Intervention Description

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.

Primary Outcome Measure Information:

Title

Change in centre of mass of the Case

Description

For the purpose of qualitative assessment of kinematics and kinetics

Time Frame

Assessment at session no. 3 (during week 1) and session no. 30 (during week 10)

Title

Change in centre of pressure of the Case

Description

For the purpose of qualitative assessment of kinematics and kinetics

Time Frame

Assessment at session no. 3 (during week 1) and session no. 30 (during week 10)

Title

Change in ground reaction force of the Case

Description

For the purpose of qualitative assessment of kinematics and kinetics

Time Frame

Assessment at session no. 3 (during week 1) and session no. 30 (during week 10)

Secondary Outcome Measure Information:

Title

Centre of mass of the Control

Description

For the purpose of qualitative assessment of spatio-temporal characteristics of stepping

Time Frame

During the only session (i.e., session 1 on day 1)

Title

Centre of pressure of the Control

Description

For the purpose of qualitative assessment of spatio-temporal characteristics of stepping

Time Frame

During the only session (i.e., session 1 on day 1)

Title

Ground reaction force of the Control

Description

For the purpose of qualitative assessment of spatio-temporal characteristics of stepping

Time Frame

During the only session (i.e., session 1 on day 1)

Other Pre-specified Outcome Measures:

Title

Step length

Description

For the purpose of qualitative assessment of spatio-temporal characteristics of stepping

Time Frame

During both assessment sessions for the Case (i.e., session no. 3 during week 1, and session no. 30 during week 10); during the only session (i.e., session 1 on day 1) for the Control

Title

Step width

Description

For the purpose of qualitative assessment of spatio-temporal characteristics of stepping

Time Frame

During both assessment sessions for the Case (i.e., session no. 3 during week 1, and session no. 30 during week 10); during the only session (i.e., session 1 on day 1) for the Control

Title

Step time

Description

For the purpose of qualitative assessment of spatio-temporal characteristics of stepping

Time Frame

During both assessment sessions for the Case (i.e., session no. 3 during week 1, and session no. 30 during week 10); during the only session (i.e., session 1 on day 1) for the Control

Title

Electromiography (at M. tibialis anterior, M. soleus, M. gastrocnemius lat., M. gastrocnemius med., M. rectus femoris, M. semitendinosus, M. gluteus med., M. gluteus max.)

Description

For the purpose of qualitative assessment

Time Frame

During both assessment sessions for the Case (i.e., session no. 3 during week 1, and session no. 30 during week 10); during the only session (i.e., session 1 on day 1) for the Control

10. Eligibility

Sex

Male

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion criteria: Case: community-dwelling, high-functioning stroke survivor Control: healthy volunteer, height- and weight-matched to the Case Exclusion criteria: any disease or injury affecting cognition any disease or injury affecting balance or gait

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Zlatko Matjačić, PhD

Organizational Affiliation

University Rehabilitation Institute, Republic of Slovenia

Official's Role

Principal Investigator

Facility Information:

Facility Name

University Rehabilitation Institute, Republic of Slovenia

City

Ljubljana

ZIP/Postal Code

1000

Country

Slovenia

12. IPD Sharing Statement

Plan to Share IPD

Undecided

Citations:

PubMed Identifier

27287551

Citation

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.

Results Reference

background

PubMed Identifier

29642921

Citation

Matjacic 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.

Results Reference

derived

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Perturbed-balance Training During Treadmill Walking for Stroke Subjects

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