Stroke
Conditions
Keywords
gait training, dynamic balance, gait symmetry, rehabilitation robotics
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.
Interventions
DEVICEStandard 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.
DEVICERobotised 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.
Sponsors
University Rehabilitation Institute, Republic of Slovenia
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DEVICE_FEASIBILITY
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 99 Years
Healthy volunteers
No
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).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in postural stability during walking | 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
| Measure | Time frame | Description |
|---|---|---|
| Change in functional ambulation category | 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. |
| Change in functional independence | 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. |
| Change in fall-risk related mobility | 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). |
| Change in walking speed over a short distance | Assessment before and after the 3-week training programme | Assessed using the 10 Meter Walk Test (10MWT) |
| Change in walking speed over a long distance | Assessment before and after the 3-week training programme | Assessed using the 6 Minute Walk Test (6MWT) |
| Change in ability to change directions while stepping | 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. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Changes in kinesiological characteristics of gait | Assessment before and after the 3-week training programme | Assessed using the BART device |
Countries
Slovenia
Outcome results
None listed