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Clinical Trials/NCT03782948
NCT03782948
Completed
Not Applicable

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

University Rehabilitation Institute, Republic of Slovenia1 site in 1 country10 target enrollmentJanuary 31, 2019
ConditionsStroke

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Stroke
Sponsor
University Rehabilitation Institute, Republic of Slovenia
Enrollment
10
Locations
1
Primary Endpoint
Change in postural stability during walking
Status
Completed
Last Updated
5 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
January 31, 2019
End Date
December 31, 2020
Last Updated
5 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

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).

Outcomes

Primary Outcomes

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

  • Change in functional ambulation category(Assessment before and after the 3-week training programme)
  • Change in fall-risk related mobility(Assessment before and after the 3-week training programme)
  • Change in functional independence(Assessment before and after the 3-week training programme)
  • Change in ability to change directions while stepping(Assessment before and after the 3-week training programme)
  • Change in walking speed over a short distance(Assessment before and after the 3-week training programme)
  • Change in walking speed over a long distance(Assessment before and after the 3-week training programme)

Study Sites (1)

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