Perturbed-balance Training During Treadmill Walking for Stroke Subjects

NCT03285919 | Completed

• 1 other identifier: URIS201703
• Study Type: interventional
• Target: 2
• Locations: 1 country
• Sites: 1

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.

Conditions

Stroke

Keywords

perturbed walking; stepping response

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (3)

• Centre of mass of the Control

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

• Centre of pressure of the Control

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

• Ground reaction force of the Control

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

Other Outcomes (4)

• Step length

  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

  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

  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

Study Arms (2)

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.

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.

Device: Balance Assessment Robot (BAR™)

Interventions

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.

Case - stroke survivor; Control - matched healthy subject

Eligibility Criteria

• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• University Rehabilitation Institute, Republic of Slovenia: lead

Study Sites (1)

University Rehabilitation Institute, Republic of Slovenia

Ljubljana, 1000, Slovenia

Location

Related Publications (2)

• 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.

  PMID: 27287551 BACKGROUND

• 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.

  PMID: 29642921 DERIVED

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Zlatko Matjačić, PhD

  University Rehabilitation Institute, Republic of Slovenia

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DEVICE FEASIBILITY
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 5, 2017
• First Posted: September 18, 2017
• Study Start: December 5, 2016
• Primary Completion: June 2, 2017
• Study Completion: June 2, 2017
• Last Updated: September 18, 2017

Record last verified: 2017-09

Locations

SL (1)