Effect of Robotised Gait Training on Dynamic Balance, Symmetry and Push-off in Persons After Stroke (BART)

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.

Study Overview

• Status: Completed
• Conditions: Stroke
• Intervention / Treatment: Device: Standard gait training on BART without pelvic perturbations; Device: Robotised gait training with BART with pelvic perturbations

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 Type: Interventional
• Enrollment (Actual): 10
• 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: 14 years to 95 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• 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).

Exclusion Criteria:

• Degenerative process or postoperative condition on lower-limb joints that would hinder gait;
• Associated neurological disease;
• Decreased cognitive ability (KPSS < 25).

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Controls; 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.	Device: Standard gait training on BART without pelvic perturbations; 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.
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.	Device: Robotised gait training with BART with pelvic perturbations; In addition to the standard gait training, the BART will deliver perturbations in the forward/backward and left/right direction.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Assessment before and after the 3-week training programme

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	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).	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.	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)	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)	Assessment before and after the 3-week training programme

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Changes in kinesiological characteristics of gait	Assessed using the BART device	Assessment before and after the 3-week training programme

Collaborators and Investigators

• Sponsor: University Rehabilitation Institute, Republic of Slovenia
• Investigators: Principal Investigator: Matjaž Zadravec, PhD, University Rehabilitation Institute, Republic of Slovenia

Study record dates

Study Major Dates

• Study Start (Actual): January 31, 2019
• Primary Completion (Actual): December 31, 2020
• Study Completion (Actual): December 31, 2020

Study Registration Dates

• First Submitted: December 18, 2018
• First Submitted That Met QC Criteria: December 18, 2018
• First Posted (Actual): December 20, 2018

Study Record Updates

• Last Update Posted (Actual): February 15, 2021
• Last Update Submitted That Met QC Criteria: February 12, 2021
• Last Verified: February 1, 2021

More Information

Terms related to this study

• Keywords: dynamic balance; gait training; rehabilitation robotics; gait symmetry
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Stroke
• Other Study ID Numbers: URIS201802

Drug and device information, study documents

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