Robotic Assessment of Lower Extremity Motor Learning
| Tracking Information | |||||
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| First Received Date ICMJE | May 25, 2011 | ||||
| Last Updated Date | May 1, 2013 | ||||
| Start Date ICMJE | February 2010 | ||||
| Estimated Primary Completion Date | November 2013 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
Rate of subject motor adaptation [ Time Frame: 4 hours ] [ Designated as safety issue: No ] rate subject motor adaptation |
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| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | Complete list of historical versions of study NCT01361867 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE | Not Provided | ||||
| Original Secondary Outcome Measures ICMJE | Not Provided | ||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Robotic Assessment of Lower Extremity Motor Learning | ||||
| Official Title ICMJE | Robotic Assessment of Lower Extremity | ||||
| Brief Summary | 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. |
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| Detailed Description | Current rehabilitation assessment techniques make it difficult to monitor the day to day changes in patient functional abilities. In an ideal setting, one would like to be able to observe how subtle changes in the way that therapy is delivered affects the manner and the time it takes patients to learn the adaptations necessary to recover lost function. To this end, the investigators seek to apply a paradigm that has been used to study motor learning in the upper extremity (the FFAP) to the Lokomat gait orthosis platform. Over the last decade the FFAP has been used to elucidate the mechanisms and processes that contribute to motor learning in the upper extremity. The broad acceptance of this paradigm within the motor control community sets a precedent for application to the lower extremity and its use in clinical environments. Implementation of the FFAP in the Lokomat system will allow motor learning to be assessed during lower extremity motor tasks. Such a tool could be used to systemically assess the effectiveness of different aspects of therapy, such as the effects of training session duration, number of exercise repetitions, inter-trial (inter-session) intervals, and magnitude of perturbation. In this initial pilot, the investigators seek to apply our Lokomat implementation of the FFAP to healthy adult subjects in order to understand the feasibility of this approach and form a database of healthy subject learning rates. This initial step will allow us to bridge the scientific gap between lower extremity and upper limb motor learning research, while yielding data that can serve as a basis of comparison for future studies with patients. Additionally, such a methodology would suggest new avenues of research for lower limb motor learning and create an increased understanding of the motor principles that govern the spectrum of human movements. Ultimately, by understanding the fundamental motor learning principles that drive neurorehabilitation the investigators can better understand what makes rehabilitation successful and attempt to better improve current rehabilitation protocols. Before the testing session begins, the subject will be placed within the Lokomat by securing subjects at the trunk, pelvis, and lower extremities using adjustable cuffs with Velcro straps, so that the hip and knee joints are aligned to those of the Lokomat. Each testing session will begin with walking for approximately 5 minutes in the standard clinical mode of operation. Optional use of body weight support and foot straps can be used to ensure subject is walking comfortably within the Lokomat. Clinical mode allows subject to be walked by the Lokomat along a predefined trajectory with the pace of the treadmill matched to the robotic legs. After subject has acclimated to Lokomat walking, the motor learning experiments will begin. The format of the motor learning experiments is as follows:
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| Study Type ICMJE | Interventional | ||||
| Study Phase | Phase 0 | ||||
| Study Design ICMJE | Allocation: Randomized Intervention Model: Single Group Assignment Masking: Single Blind (Subject) Primary Purpose: Basic Science |
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| Condition ICMJE | Healthy Subjects | ||||
| Intervention ICMJE | Other: Lokomat
The subject is put into the Lokomat and the program will vary between free walking and perturbed walking. |
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| Study Arm (s) | Experimental: Lokomat session
The subject is put on the Lokomat and the program will vary between free walking and perturbed walking.
Intervention: Other: Lokomat |
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| Publications * | Not Provided | ||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Active, not recruiting | ||||
| Estimated Enrollment ICMJE | 40 | ||||
| Completion Date | Not Provided | ||||
| Estimated Primary Completion Date | November 2013 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||
| Ages | 18 Years to 55 Years | ||||
| Accepts Healthy Volunteers | Yes | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | United States | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT01361867 | ||||
| Other Study ID Numbers ICMJE | 2009-P-002030 | ||||
| Has Data Monitoring Committee | No | ||||
| Responsible Party | Paolo Bonato, Spaulding Rehabilitation Hospital | ||||
| Study Sponsor ICMJE | Spaulding Rehabilitation Hospital | ||||
| Collaborators ICMJE | Not Provided | ||||
| Investigators ICMJE |
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| Information Provided By | Spaulding Rehabilitation Hospital | ||||
| Verification Date | May 2013 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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