Clinical trial NCT03285919: Perturbed-balance Training During Treadmill Walking for Stroke Subjects
Official title: Feasibility of Perturbed-balance Training During Treadmill Walking in a High-functioning Chronic Stroke Subject: a Case-control Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Stroke
Keywords: perturbed walking
stepping response
Lead sponsor: University Rehabilitation Institute, Republic of Slovenia
Sponsor class: OTHER
First posted: 2017-09-18
Enrollment: 2
Sex: MALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DEVICE_FEASIBILITY

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.

Eligibility criteria: 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

Primary outcomes:
measure: Change in centre of mass of the Case
timeFrame: Assessment at session no. 3 (during week 1) and session no. 30 (during week 10)
measure: Change in centre of pressure of the Case
timeFrame: Assessment at session no. 3 (during week 1) and session no. 30 (during week 10)
measure: Change in ground reaction force of the Case
timeFrame: Assessment at session no. 3 (during week 1) and session no. 30 (during week 10)
Secondary outcomes:
measure: Centre of mass of the Control
timeFrame: During the only session (i.e., session 1 on day 1)
measure: Centre of pressure of the Control
timeFrame: During the only session (i.e., session 1 on day 1)
measure: Ground reaction force of the Control
timeFrame: During the only session (i.e., session 1 on day 1)
Other outcomes:
measure: Step length
timeFrame: 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
measure: Step width
timeFrame: 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
measure: Step time
timeFrame: 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
measure: Electromiography (at M. tibialis anterior, M. soleus, M. gastrocnemius lat., M. gastrocnemius med., M. rectus femoris, M. semitendinosus, M. gluteus med., M. gluteus max.)
timeFrame: 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
Locations:
city: Ljubljana
country: Slovenia
facility: University Rehabilitation Institute, Republic of Slovenia
Study officials:
affiliation: University Rehabilitation Institute, Republic of Slovenia
name: Zlatko Matjačić, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Olensek 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.
citation: Matjacic Z, Zadravec M, Olensek A. Feasibility of robot-based perturbed-balance training during treadmill walking in a high-functioning chronic stroke subject: a case-control study. J Neuroeng Rehabil. 2018 Apr 11;15(1):32. doi: 10.1186/s12984-018-0373-z.