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

Primary Purpose

Stroke

Status
Completed
Phase
Not Applicable
Locations
Slovenia
Study Type
Interventional
Intervention
Standard gait training on BART without pelvic perturbations
Robotised gait training with BART with pelvic perturbations
Sponsored by
University Rehabilitation Institute, Republic of Slovenia
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional device feasibility trial for Stroke focused on measuring gait training, dynamic balance, gait symmetry, rehabilitation robotics

Eligibility Criteria

18 Years - 99 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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).

Sites / Locations

  • University Rehabilitation Institute, Republic of Slovenia

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Controls

Experimental

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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.
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).
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.
Change in walking speed over a short distance
Assessed using the 10 Meter Walk Test (10MWT)
Change in walking speed over a long distance
Assessed using the 6 Minute Walk Test (6MWT)

Full Information

First Posted
December 18, 2018
Last Updated
February 12, 2021
Sponsor
University Rehabilitation Institute, Republic of Slovenia
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1. Study Identification

Unique Protocol Identification Number
NCT03782948
Brief Title
Effect of Robotised Gait Training on Dynamic Balance, Symmetry and Push-off in Persons After Stroke
Acronym
BART
Official Title
Effect of Robotised Gait Training on Dynamic Balance, Symmetry and Push-off in Persons After Stroke
Study Type
Interventional

2. Study Status

Record Verification Date
February 2021
Overall Recruitment Status
Completed
Study Start Date
January 31, 2019 (Actual)
Primary Completion Date
December 31, 2020 (Actual)
Study Completion Date
December 31, 2020 (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
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke
Keywords
gait training, dynamic balance, gait symmetry, rehabilitation robotics

7. Study Design

Primary Purpose
Device Feasibility
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
10 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Controls
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Experimental
Arm Type
Experimental
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
Standard gait training on BART without pelvic perturbations
Intervention Description
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.
Intervention Type
Device
Intervention Name(s)
Robotised gait training with BART with pelvic perturbations
Intervention Description
In addition to the standard gait training, the BART will deliver perturbations in the forward/backward and left/right direction.
Primary Outcome Measure Information:
Title
Change in postural stability during walking
Description
Assessed using the Functional Gait Assessment (FGA) scale. The scale scores range from 0 to 30, with higher scores indicating less impairment.
Time Frame
Assessment before and after the 3-week training programme
Secondary Outcome Measure Information:
Title
Change in functional ambulation category
Description
Assessed using the Functional Ambulation Categories (FAC) scale. The FAC is a 6-point scale (0-5), with higher category indicating better walking ability.
Time Frame
Assessment before and after the 3-week training programme
Title
Change in functional independence
Description
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.
Time Frame
Assessment before and after the 3-week training programme
Title
Change in fall-risk related mobility
Description
Assessed using the Timed Up and Go (TUG) test. Longer TUG times indicate worse mobility (and thus higher fall risk).
Time Frame
Assessment before and after the 3-week training programme
Title
Change in ability to change directions while stepping
Description
Assessed using the Four Square Step Test (FSST). The FSST is timed, with longer times indicating worse ability.
Time Frame
Assessment before and after the 3-week training programme
Title
Change in walking speed over a short distance
Description
Assessed using the 10 Meter Walk Test (10MWT)
Time Frame
Assessment before and after the 3-week training programme
Title
Change in walking speed over a long distance
Description
Assessed using the 6 Minute Walk Test (6MWT)
Time Frame
Assessment before and after the 3-week training programme
Other Pre-specified Outcome Measures:
Title
Changes in kinesiological characteristics of gait
Description
Assessed using the BART device
Time Frame
Assessment before and after the 3-week training programme

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
99 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Matjaž Zadravec, 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

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

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