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Robotic Assessment of Lower Extremity Motor Learning

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01361867
First Posted: May 27, 2011
Last Update Posted: May 30, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Paolo Bonato, Spaulding Rehabilitation Hospital
May 25, 2011
May 27, 2011
April 10, 2017
May 30, 2017
May 30, 2017
November 2009
June 2015   (Final data collection date for primary outcome measure)
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
Rate of subject motor adaptation [ Time Frame: 4 hours ]
rate subject motor adaptation
Complete list of historical versions of study NCT01361867 on ClinicalTrials.gov Archive Site
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
Not Provided
Not Provided
Not Provided
 
Robotic Assessment of Lower Extremity Motor Learning
Robotic Assessment of Lower Extremity Motor Learning
The aim of the study is to assess the ability of healthy subjects to generate a motor adaptation in response to a mechanical perturbation generated by a robotic system for treadmill-based gait training (Lokomat by Hocoma AG, a device that received 510K FDA clearance).

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.

Interventional
Not Provided
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Healthy Subjects
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.
Robot-induced perturbations
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.
Intervention: Device: Robot-induced perturbations
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
15
June 2015
June 2015   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • Males and females, healthy adults age 18-55 years, with normal gait.

Exclusion Criteria:

  • Lower extremity fractures
  • Current or previous history of orthopedic injury that would prevent safe use of the robotic system
  • Body/femoral length size beyond the limits of robotic system (femur length between 350-470mm)
  • Body weight > 135kg (~298 lbs) maximum limit of the body weight support system
  • Skin lesions on the lower extremities
  • Cardiovascular or pulmonary contraindications
  • Motor system or proprioceptive impairments
  • Severe cognitive impairments that would prevent the use of the robotic system
Sexes Eligible for Study: All
18 Years to 55 Years   (Adult)
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT01361867
2009-P-002030
No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Pediatric Postmarket Surveillance of a Device Product: No
Product Manufactured in and Exported from the U.S.: No
Plan to Share IPD: No
Paolo Bonato, Spaulding Rehabilitation Hospital
Spaulding Rehabilitation Hospital
Not Provided
Principal Investigator: Paolo Bonato, PhD Spaulding Rehabilitation Hospital
Spaulding Rehabilitation Hospital
May 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP
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