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Clinical Trials/NCT01361867
NCT01361867
Completed
Not Applicable

Robotic Assessment of Lower Extremity Motor Learning

Spaulding Rehabilitation Hospital1 site in 1 country15 target enrollmentNovember 2009

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Healthy Subjects
Sponsor
Spaulding Rehabilitation Hospital
Enrollment
15
Locations
1
Primary Endpoint
Step Length Adaptation
Status
Completed
Last Updated
8 years ago

Overview

Brief Summary

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).

Detailed Description

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.

Registry
clinicaltrials.gov
Start Date
November 2009
End Date
June 2015
Last Updated
8 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Sponsor
Spaulding Rehabilitation Hospital
Responsible Party
Principal Investigator
Principal Investigator

Paolo Bonato

Director, Motion Analysis Laboratory

Spaulding Rehabilitation Hospital

Eligibility Criteria

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

Outcomes

Primary Outcomes

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

Secondary Outcomes

  • Step Height Adaptation(within a trial of the experiment (i.e. a few minutes))

Study Sites (1)

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