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

Stroke Clinical Trial

— BART  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03782948
• Other study ID #: URIS201802
• Status: Completed
• Phase: N/A
• Start date: January 31, 2019
• Est. completion date: December 31, 2020

Study information

• Verified date: February 2021
• Source: University Rehabilitation Institute, Republic of Slovenia
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10
• Est. completion date: December 31, 2020
• Est. primary completion date: December 31, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 99 Years

Eligibility

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).

Related Conditions & MeSH terms

• Stroke

Intervention

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.
• 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.

Locations

Country	Name	City	State
Slovenia	University Rehabilitation Institute, Republic of Slovenia	Ljubljana

Sponsors (1)

Lead Sponsor	Collaborator
University Rehabilitation Institute, Republic of Slovenia

Country where clinical trial is conducted

Slovenia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Changes in kinesiological characteristics of gait	Assessed using the BART device	Assessment before and after the 3-week training programme
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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