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

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ClinicalTrials.gov Identifier: NCT03782948
Recruitment Status : Completed
First Posted : December 20, 2018
Last Update Posted : February 15, 2021
Sponsor:
Information provided by (Responsible Party):
University Rehabilitation Institute, Republic of Slovenia

Study Description
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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.

Condition or disease Intervention/treatment Phase
Stroke Device: Standard gait training on BART without pelvic perturbations Device: Robotised gait training with BART with pelvic perturbations Not Applicable

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 10 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Device Feasibility
Official Title: Effect of Robotised Gait Training on Dynamic Balance, Symmetry and Push-off in Persons After Stroke
Actual Study Start Date : January 31, 2019
Actual Primary Completion Date : December 31, 2020
Actual Study Completion Date : December 31, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Rehabilitation

Arms and Interventions
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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.


Outcome Measures
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Primary Outcome Measures :
  1. Change in postural stability during walking [ Time Frame: Assessment before and after the 3-week training programme ]
    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 :
  1. Change in functional ambulation category [ Time Frame: Assessment before and after the 3-week training programme ]
    Assessed using the Functional Ambulation Categories (FAC) scale. The FAC is a 6-point scale (0-5), with higher category indicating better walking ability.

  2. Change in functional independence [ Time Frame: Assessment before and after the 3-week training programme ]
    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.

  3. Change in fall-risk related mobility [ Time Frame: Assessment before and after the 3-week training programme ]
    Assessed using the Timed Up and Go (TUG) test. Longer TUG times indicate worse mobility (and thus higher fall risk).

  4. Change in ability to change directions while stepping [ Time Frame: Assessment before and after the 3-week training programme ]
    Assessed using the Four Square Step Test (FSST). The FSST is timed, with longer times indicating worse ability.

  5. Change in walking speed over a short distance [ Time Frame: Assessment before and after the 3-week training programme ]
    Assessed using the 10 Meter Walk Test (10MWT)

  6. Change in walking speed over a long distance [ Time Frame: Assessment before and after the 3-week training programme ]
    Assessed using the 6 Minute Walk Test (6MWT)


Other Outcome Measures:
  1. Changes in kinesiological characteristics of gait [ Time Frame: Assessment before and after the 3-week training programme ]
    Assessed using the BART device


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 99 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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).
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03782948


Locations
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Slovenia
University Rehabilitation Institute, Republic of Slovenia
Ljubljana, Slovenia, 1000
Sponsors and Collaborators
University Rehabilitation Institute, Republic of Slovenia
Investigators
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Principal Investigator: Matjaž Zadravec, PhD University Rehabilitation Institute, Republic of Slovenia
More Information
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Responsible Party: University Rehabilitation Institute, Republic of Slovenia
ClinicalTrials.gov Identifier: NCT03782948    
Other Study ID Numbers: URIS201802
First Posted: December 20, 2018    Key Record Dates
Last Update Posted: February 15, 2021
Last Verified: February 2021

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University Rehabilitation Institute, Republic of Slovenia:
gait training
dynamic balance
gait symmetry
rehabilitation robotics
Additional relevant MeSH terms:
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Stroke
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
 Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases