Robotic Assessment of Lower Extremity Motor Learning
|ClinicalTrials.gov Identifier: NCT01361867|
Recruitment Status : Completed
First Posted : May 27, 2011
Results First Posted : May 30, 2017
Last Update Posted : May 30, 2017
|Condition or disease||Intervention/treatment||Phase|
|Healthy Subjects||Device: Robot-induced perturbations||Not Applicable|
The study is divided into two phases.
In phase I of the study, we intend to assess the response of individuals to a variety of different mechanical perturbations generated by a robotic system for treadmill-based gait training (Lokomat by Hocoma AG). Such response is quantified as a displacement from the baseline (i.e. gait cycles with no mechanical perturbation) trajectory of motion of the foot during the swing phase of the gait cycle. This portion of the study is expected to allow us to identify mechanical perturbations that are suitable to study motor adaptation.
In phase II of the study, we plan to carry out experiments using the above-mentioned robotic system to assess the magnitude of the motor adaptation to the mechanical perturbations identified in phase I as suitable for the study. The magnitude of the motor adaptation is quantified as the percentage of the deviation from the baseline trajectory of motion of the foot that subjects compensate for when exposed to the perturbation during multiple consecutive gait cycles.
It is worth noticing that the robotic system utilized to generate the mechanical perturbations (i.e. Lokomat by Hocoma AG) is not programmed by the company to generate the mechanical perturbations evaluated in this project. Our research group wrote the programs to generate such perturbations. It is also worth emphasizing that the 510K FDA clearance does not cover the modifications implemented by our research group.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||15 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Primary Purpose:||Basic Science|
|Official Title:||Robotic Assessment of Lower Extremity Motor Learning|
|Actual Study Start Date :||November 2009|
|Actual Primary Completion Date :||June 2015|
|Actual Study Completion Date :||June 2015|
The subject walks on a treadmill with his/her legs strapped to a robotic system (Lokomat by Hocoma AG) that generates mechanical perturbations aimed to modify the subject's walking pattern.
Device: Robot-induced perturbations
A robotic system is used to generate mechanical perturbations and study how subjects generate motor adaptations in response to the mechanical perturbations.
- Step Length Adaptation [ Time Frame: within a trial of the experiment (i.e. a few minutes) ]The percentage of the step length change caused by the mechanical perturbation that subjects compensate for
- Step Height Adaptation [ Time Frame: within a trial of the experiment (i.e. a few minutes) ]The percentage of the step height change caused by the mechanical perturbation that subjects compensate for
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01361867
|United States, Massachusetts|
|Spaulding Rehabilitation Hospital Boston|
|Boston, Massachusetts, United States, 02129|
|Principal Investigator:||Paolo Bonato, PhD||Spaulding Rehabilitation Hospital|