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Completed

NCT Number: NCT03782948

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

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.

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Key information

Conditions

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

Age range

18 year–99 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University Rehabilitation Institute, Republic of Slovenia

Ljubljana, 1000, Slovenia

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

Standard gait training on BART without pelvic perturbations

Device

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.

Robotised gait training with BART with pelvic perturbations

Device

In addition to the standard gait training, the BART will deliver perturbations in the forward/backward and left/right direction.

Primary outcomes

  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 outcomes

  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 outcomes

  1. Changes in kinesiological characteristics of gait

    Time frame: Assessment before and after the 3-week training programme

    Assessed using the BART device

Sponsors and collaborators

Lead sponsor

University Rehabilitation Institute, Republic of Slovenia

Other

Registry information

Acronym: BART

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Dec 20, 2018
Registry last updated
Feb 15, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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