Robotic Assessment of Lower Extremity Motor Learning

Healthy Subjects Clinical Trial

Official title:

Robotic Assessment of Lower Extremity Motor Learning

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01361867
• Other study ID #: 2009-P-002030
• Status: Completed
• Phase: N/A
• First received: May 25, 2011
• Last updated: May 23, 2017
• Start date: November 2009
• Est. completion date: June 2015

Study information

• Verified date: May 2017
• Source: Spaulding Rehabilitation Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 15
• Est. completion date: June 2015
• Est. primary completion date: June 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 55 Years

Eligibility

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

Related Conditions & MeSH terms

• Healthy Subjects

Intervention

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.

Locations

Country	Name	City	State
United States	Spaulding Rehabilitation Hospital Boston	Boston	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Spaulding Rehabilitation Hospital

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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)