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).

Study Overview

• Status: Completed
• Conditions: Healthy Subjects
• Intervention / Treatment: Device: Robot-induced perturbations

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.

• Study Type: Interventional
• Enrollment (Actual): 15
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Massachusetts
    • Boston, Massachusetts, United States, 02129
      • Spaulding Rehabilitation Hospital Boston

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 55 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: 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.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Step Length Adaptation	The percentage of the step length change caused by the mechanical perturbation that subjects compensate for	within a trial of the experiment (i.e. a few minutes)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Step Height Adaptation	The percentage of the step height change caused by the mechanical perturbation that subjects compensate for	within a trial of the experiment (i.e. a few minutes)

Collaborators and Investigators

• Sponsor: Spaulding Rehabilitation Hospital

Study record dates

Study Major Dates

• Study Start (Actual): November 1, 2009
• Primary Completion (Actual): June 1, 2015
• Study Completion (Actual): June 1, 2015

Study Registration Dates

• First Submitted: May 25, 2011
• First Submitted That Met QC Criteria: May 26, 2011
• First Posted (Estimate): May 27, 2011

Study Record Updates

• Last Update Posted (Actual): May 30, 2017
• Last Update Submitted That Met QC Criteria: May 23, 2017
• Last Verified: May 1, 2017

More Information

Terms related to this study

• Keywords: motor adaptation; lower extremity motor learning
• Other Study ID Numbers: 2009-P-002030

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No