Perturbed-balance Training During Treadmill Walking for Stroke Subjects

Not Applicable

Completed

• Conditions: Stroke
• Interventions: Device: Balance Assessment Robot (BAR™)

• Registration Number: NCT03285919
• Lead Sponsor: University Rehabilitation Institute, Republic of Slovenia

Brief Summary

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.

Detailed Description

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

Study Timeline

• Study Start: 2016-12-05
• Primary Completion: 2017-06-02
• Study Completion: 2017-06-02
• Status Verified: 2017-09
• Study First Submitted: 2017-09-05
• Study First Submitted QC: 2017-09-15
• Last Update Submitted: 2017-09-15
• Study First Posted: 2017-09-18
• Last Update Posted: 2017-09-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 2

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Case - stroke survivor	Balance Assessment Robot (BAR™)	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.
Control - matched healthy subject	Balance Assessment Robot (BAR™)	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.

Primary Outcome Measures

Name	Time	Method
Change in centre of mass of the Case	Assessment at session no. 3 (during week 1) and session no. 30 (during week 10)	For the purpose of qualitative assessment of kinematics and kinetics
Change in centre of pressure of the Case	Assessment at session no. 3 (during week 1) and session no. 30 (during week 10)	For the purpose of qualitative assessment of kinematics and kinetics
Change in ground reaction force of the Case	Assessment at session no. 3 (during week 1) and session no. 30 (during week 10)	For the purpose of qualitative assessment of kinematics and kinetics

Secondary Outcome Measures

Name	Time	Method
Centre of pressure of the Control	During the only session (i.e., session 1 on day 1)	For the purpose of qualitative assessment of spatio-temporal characteristics of stepping
Centre of mass of the Control	During the only session (i.e., session 1 on day 1)	For the purpose of qualitative assessment of spatio-temporal characteristics of stepping
Ground reaction force of the Control	During the only session (i.e., session 1 on day 1)	For the purpose of qualitative assessment of spatio-temporal characteristics of stepping

Trial Locations

Locations (1)

University Rehabilitation Institute, Republic of Slovenia; 🇸🇮 Ljubljana, Slovenia