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Completed

NCT Number: NCT03285919

Perturbed-balance Training During Treadmill Walking for Stroke Subjects

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.

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Key information

Conditions

Stroke Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Nervous System Diseases Vascular Diseases

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

University Rehabilitation Institute, Republic of Slovenia

Ljubljana, 1000, Slovenia

About this study

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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Balance Assessment Robot (BAR™)

Device

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.

Primary outcomes

  1. Change in centre of mass of the Case

    Time frame: 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

  2. Change in centre of pressure of the Case

    Time frame: 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

  3. Change in ground reaction force of the Case

    Time frame: 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 outcomes

  1. Centre of mass of the Control

    Time frame: During the only session (i.e., session 1 on day 1)

    For the purpose of qualitative assessment of spatio-temporal characteristics of stepping

  2. Centre of pressure of the Control

    Time frame: During the only session (i.e., session 1 on day 1)

    For the purpose of qualitative assessment of spatio-temporal characteristics of stepping

  3. Ground reaction force of the Control

    Time frame: During the only session (i.e., session 1 on day 1)

    For the purpose of qualitative assessment of spatio-temporal characteristics of stepping

Other outcomes

  1. Step length

    Time frame: 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

    For the purpose of qualitative assessment of spatio-temporal characteristics of stepping

  2. Step width

    Time frame: 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

    For the purpose of qualitative assessment of spatio-temporal characteristics of stepping

  3. Step time

    Time frame: 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

    For the purpose of qualitative assessment of spatio-temporal characteristics of stepping

  4. Electromiography (at M. tibialis anterior, M. soleus, M. gastrocnemius lat., M. gastrocnemius med., M. rectus femoris, M. semitendinosus, M. gluteus med., M. gluteus max.)

    Time frame: 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

    For the purpose of qualitative assessment

Sponsors and collaborators

Lead sponsor

University Rehabilitation Institute, Republic of Slovenia

Other

Registry information

Official study title

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

Acronym: BALANCESI

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
Sep 18, 2017
Registry last updated
Sep 18, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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