Perturbed-balance Training During Treadmill Walking for Stroke Subjects

Stroke Clinical Trial

— BALANCESI  

Official title:

Feasibility of Perturbed-balance Training During Treadmill Walking in a High-functioning Chronic Stroke Subject: a Case-control Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03285919
• Other study ID #: URIS201703
• Status: Completed
• Phase: N/A
• First received: September 5, 2017
• Last updated: September 15, 2017
• Start date: December 5, 2016
• Est. completion date: June 2, 2017

Study information

• Verified date: September 2017
• Source: University Rehabilitation Institute, Republic of Slovenia
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 2
• Est. completion date: June 2, 2017
• Est. primary completion date: June 2, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Stroke

Intervention

Device:
• Balance Assessment Robot (BAR™)
The BAR™ has got six degrees of freedom (DOF) that interface to the pelvis of a walking subject. Five DOFs (translation of pelvis in sagittal, lateral and vertical directions; pelvic rotation and pelvic list) are actuated and admittance-controlled, providing transparent haptic interaction with negligible power transfer; the remaining DOF (pelvic tilt) is passive. The BAR™ is capable of delivering perturbations in the directions forward/backward and left/right, but for the purpose of this study only "outward" perturbations in the frontal plane were considered.

Locations

Country	Name	City	State
Slovenia	University Rehabilitation Institute, Republic of Slovenia	Ljubljana

Sponsors (1)

Lead Sponsor	Collaborator
University Rehabilitation Institute, Republic of Slovenia

Country where clinical trial is conducted

Slovenia, 

References & Publications (1)

Olenšek A, Zadravec M, Matjacic Z. A novel robot for imposing perturbations during overground walking: mechanism, control and normative stepping responses. J Neuroeng Rehabil. 2016 Jun 11;13(1):55. doi: 10.1186/s12984-016-0160-7. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Step length	For the purpose of qualitative assessment of spatio-temporal characteristics of stepping	During both assessment sessions for the Case (i.e., session no. 3 during week 1, and session no. 30 during week 10); during the only session (i.e., session 1 on day 1) for the Control
Other	Step width	For the purpose of qualitative assessment of spatio-temporal characteristics of stepping	During both assessment sessions for the Case (i.e., session no. 3 during week 1, and session no. 30 during week 10); during the only session (i.e., session 1 on day 1) for the Control
Other	Step time	For the purpose of qualitative assessment of spatio-temporal characteristics of stepping	During both assessment sessions for the Case (i.e., session no. 3 during week 1, and session no. 30 during week 10); during the only session (i.e., session 1 on day 1) for the Control
Other	Electromiography (at M. tibialis anterior, M. soleus, M. gastrocnemius lat., M. gastrocnemius med., M. rectus femoris, M. semitendinosus, M. gluteus med., M. gluteus max.)	For the purpose of qualitative assessment	During both assessment sessions for the Case (i.e., session no. 3 during week 1, and session no. 30 during week 10); during the only session (i.e., session 1 on day 1) for the Control
Primary	Change in centre of mass of the Case	For the purpose of qualitative assessment of kinematics and kinetics	Assessment at session no. 3 (during week 1) and session no. 30 (during week 10)
Primary	Change in centre of pressure of the Case	For the purpose of qualitative assessment of kinematics and kinetics	Assessment at session no. 3 (during week 1) and session no. 30 (during week 10)
Primary	Change in ground reaction force of the Case	For the purpose of qualitative assessment of kinematics and kinetics	Assessment at session no. 3 (during week 1) and session no. 30 (during week 10)
Secondary	Centre of mass of the Control	For the purpose of qualitative assessment of spatio-temporal characteristics of stepping	During the only session (i.e., session 1 on day 1)
Secondary	Centre of pressure of the Control	For the purpose of qualitative assessment of spatio-temporal characteristics of stepping	During the only session (i.e., session 1 on day 1)
Secondary	Ground reaction force of the Control	For the purpose of qualitative assessment of spatio-temporal characteristics of stepping	During the only session (i.e., session 1 on day 1)