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

University Rehabilitation Institute, Republic of Slovenia

Status: Completed

Conditions: Stroke

Treatments: Device: Standard gait training on BART without pelvic perturbations; Device: Robotised gait training with BART with pelvic perturbations

Study type: Interventional

Funder types: Other

Identifiers

NCT03782948

URIS201802

Details and patient eligibility

About

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.

Full 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.

Enrollment: 10 patients

Sex: All

Ages: 18 to 99 years old

Volunteers: No Healthy Volunteers

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).

Trial design

Primary purpose: Device Feasibility

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

10 participants in 2 patient groups

Controls

Active Comparator group

Description:

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.

Treatment:

Device: Standard gait training on BART without pelvic perturbations

Experimental

Experimental group

Description:

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.

Treatment:

Device: Robotised gait training with BART with pelvic perturbations