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Completed

NCT Number: NCT01361867

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).

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Key information

Conditions

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Spaulding Rehabilitation Hospital Boston

Boston, Massachusetts, 02129, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Robot-induced perturbations

Device

A robotic system is used to generate mechanical perturbations and study how subjects generate motor adaptations in response to the mechanical perturbations.

Primary outcomes

  1. 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

  1. 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

Sponsors and collaborators

Lead sponsor

Spaulding Rehabilitation Hospital

Other

Registry information

Important dates

Study start
2009
Primary completion
2015
Study completion
2015
First posted
May 27, 2011
Registry last updated
May 30, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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