Clinical trial NCT03782948: Effect of Robotised Gait Training on Dynamic Balance, Symmetry and Push-off in Persons After Stroke
Official title: Effect of Robotised Gait Training on Dynamic Balance, Symmetry and Push-off in Persons After Stroke
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Stroke
Keywords: gait training
dynamic balance
gait symmetry
rehabilitation robotics
Lead sponsor: University Rehabilitation Institute, Republic of Slovenia
Sponsor class: OTHER
First posted: 2018-12-20
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DEVICE_FEASIBILITY

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.

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).

Primary outcomes:
measure: Change in postural stability during walking
timeFrame: Assessment before and after the 3-week training programme
Secondary outcomes:
measure: Change in functional ambulation category
timeFrame: Assessment before and after the 3-week training programme
measure: Change in functional independence
timeFrame: Assessment before and after the 3-week training programme
measure: Change in fall-risk related mobility
timeFrame: Assessment before and after the 3-week training programme
measure: Change in ability to change directions while stepping
timeFrame: Assessment before and after the 3-week training programme
measure: Change in walking speed over a short distance
timeFrame: Assessment before and after the 3-week training programme
measure: Change in walking speed over a long distance
timeFrame: Assessment before and after the 3-week training programme
Other outcomes:
measure: Changes in kinesiological characteristics of gait
timeFrame: Assessment before and after the 3-week training programme
Locations:
city: Ljubljana
country: Slovenia
facility: University Rehabilitation Institute, Republic of Slovenia
Study officials:
affiliation: University Rehabilitation Institute, Republic of Slovenia
name: Matjaž Zadravec, PhD
role: PRINCIPAL_INVESTIGATOR
References: