Perturbed-balance Training During Treadmill Walking for Stroke Subjects (BALANCESI)

University Rehabilitation Institute, Republic of Slovenia

Status: Completed

Conditions: Stroke

Treatments: Device: Balance Assessment Robot (BAR™)

Study type: Interventional

Funder types: Other

Identifiers

NCT03285919

URIS201703

Details and patient eligibility

About

A control and a post-stroke subject with right-side chronic hemiparesis were studied. The post-stroke subject underwent 30 sessions of balance-perturbed training while walking on an instrumented treadmill where the Balance Assessment Robot (BAR™) randomly delivered pushes to pelvis in various directions at various speeds and at various perturbation amplitudes. The investigators assessed kinematics, kinetics, electromiography and spatio-temporal responses to outward-directed perturbations commencing either at foot contact of the left or the right leg.

Full description

For a detailed description of the study, see the Arms and Interventions section.

Enrollment: 2 patients

Sex: Male

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Case: community-dwelling, high-functioning stroke survivor
• Control: healthy volunteer, height- and weight-matched to the Case

Exclusion criteria

• any disease or injury affecting cognition
• any disease or injury affecting balance or gait

Trial design

Primary purpose: Device Feasibility

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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2 participants in 2 patient groups

Case - stroke survivor

Experimental group

Description:

Stroke survivor, 6mon post stroke resulting in right-sided hemiparesis, 53yrs old, had completed a 2mon rehabilitation program prior to the study. He underwent 30 training sessions with the Balance Assessment Robot (BAR™) within a 10-week period, each consisting of 10-15min of unperturbed treadmill and 30-45min of perturbation training. Perturbations were delivered in the forward, backward, left and right direction, occurring every 6sec, at the left leg initial contact and the right leg initial contact. Two training sessions were spent to determine adequate treadmill speed (0.4m/s) and perturbation amplitude (60N), followed by the first assessment session. After the last training session, assessment was repeated using the same parameters plus 90N perturbation amplitude.

Treatment:

Device: Balance Assessment Robot (BAR™)

Control - matched healthy subject

Active Comparator group

Description:

Healthy male, height- and weight-matched to the Case. He was assessed according to the same protocol as the Case using the Balance Assessment Robot (BAR™) at perturbation amplitudes 60 and 90 N.

Treatment:

Device: Balance Assessment Robot (BAR™)