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Robotic Assessment of Lower Extremity Motor Learning

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Paolo Bonato, Spaulding Rehabilitation Hospital
ClinicalTrials.gov Identifier:
NCT01361867
First received: May 25, 2011
Last updated: May 1, 2013
Last verified: May 2013
History of Changes
  Purpose

The investigators hypothesize that the motor learning processes observed in the lower extremity will be similar to those seen in upper arm experiments. Furthermore, the investigators hypothesize that lower extremity motor learning can be quantified with an adapted model of the force-field adaption paradigm (FFAP) introduced by Shadmehr et al. for studying motor learning in the upper extremities.


Condition Intervention Phase
Healthy Subjects
 Other: Lokomat
 Phase 0

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Single Blind (Subject)
Primary Purpose: Basic Science
Official Title: Robotic Assessment of Lower Extremity

Resource links provided by NLM:

MedlinePlus related topics: Rehabilitation
U.S. FDA Resources

Further study details as provided by Spaulding Rehabilitation Hospital:

Primary Outcome Measures:
  • Rate of subject motor adaptation [ Time Frame: 4 hours ] [ Designated as safety issue: No ]
    rate subject motor adaptation


Estimated Enrollment: 40
Study Start Date: February 2010
Estimated Primary Completion Date: November 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Lokomat session
The subject is put on the Lokomat and the program will vary between free walking and perturbed walking.
 Other: Lokomat
The subject is put into the Lokomat and the program will vary between free walking and perturbed walking.

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years to 55 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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 Lokomat
  • Body/femoral length size beyond the limits of Lokomat robotic arm (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 Lokomat
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01361867

Locations
United States, Massachusetts
Spaulding Rehabilitation Hospital Boston
Boston, Massachusetts, United States, 02129
Sponsors and Collaborators
Spaulding Rehabilitation Hospital
Investigators
Principal Investigator: Paolo Bonato, PhD Spaulding Rehabilitation Hospital
  More Information

No publications provided

Responsible Party: Paolo Bonato, Director, Motion Analysis Laboratory, Spaulding Rehabilitation Hospital
ClinicalTrials.gov Identifier: NCT01361867     History of Changes
Other Study ID Numbers: 2009-P-002030
Study First Received: May 25, 2011
Last Updated: May 1, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Spaulding Rehabilitation Hospital:
motor adaptation
force-field adaptation paradigm
lower extremity motor learning

ClinicalTrials.gov processed this record on May 19, 2013