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

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.

Study Overview

• Status: Completed
• Conditions: Stroke
• Intervention / Treatment: Device: Balance Assessment Robot (BAR™)

Detailed Description

For a detailed description of the study, see the Arms and Interventions section.

• Study Type: Interventional
• Enrollment (Actual): 2
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Slovenia
  • Ljubljana, Slovenia, 1000
    • University Rehabilitation Institute, Republic of Slovenia

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Male

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Device Feasibility
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Case - stroke survivor; 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.	Device: 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.
Active Comparator: Control - matched healthy subject; 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.	Device: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in centre of mass of the Case	For the purpose of qualitative assessment of kinematics and kinetics	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	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	Assessment at session no. 3 (during week 1) and session no. 30 (during week 10)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Centre of mass of the Control	For the purpose of qualitative assessment of spatio-temporal characteristics of stepping	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	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	During the only session (i.e., session 1 on day 1)

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Step length	For the purpose of qualitative assessment of spatio-temporal characteristics of stepping	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
Step width	For the purpose of qualitative assessment of spatio-temporal characteristics of stepping	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
Step time	For the purpose of qualitative assessment of spatio-temporal characteristics of stepping	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
Electromiography (at M. tibialis anterior, M. soleus, M. gastrocnemius lat., M. gastrocnemius med., M. rectus femoris, M. semitendinosus, M. gluteus med., M. gluteus max.)	For the purpose of qualitative assessment	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

Collaborators and Investigators

• Sponsor: University Rehabilitation Institute, Republic of Slovenia
• Investigators: Principal Investigator: Zlatko Matjačić, PhD, University Rehabilitation Institute, Republic of Slovenia

Publications and helpful links

General 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): December 5, 2016
• Primary Completion (Actual): June 2, 2017
• Study Completion (Actual): June 2, 2017

Study Registration Dates

• First Submitted: September 5, 2017
• First Submitted That Met QC Criteria: September 15, 2017
• First Posted (Actual): September 18, 2017

Study Record Updates

• Last Update Posted (Actual): September 18, 2017
• Last Update Submitted That Met QC Criteria: September 15, 2017
• Last Verified: September 1, 2017

More Information

Terms related to this study

• Keywords: perturbed walking; stepping response
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Stroke
• Other Study ID Numbers: URIS201703

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No