Robotic Assessment of Lower Extremity Motor Learning
1 other identifier
interventional
15
1 country
1
Brief 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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Nov 2009
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 1, 2009
CompletedFirst Submitted
Initial submission to the registry
May 25, 2011
CompletedFirst Posted
Study publicly available on registry
May 27, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2015
CompletedResults Posted
Study results publicly available
May 30, 2017
CompletedMay 30, 2017
May 1, 2017
5.6 years
May 25, 2011
April 10, 2017
May 23, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (1)
Step Height Adaptation
within a trial of the experiment (i.e. a few minutes)
Study Arms (1)
Robot-induced perturbations
OTHERThe 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.
Interventions
A robotic system is used to generate mechanical perturbations and study how subjects generate motor adaptations in response to the mechanical perturbations.
Eligibility Criteria
You may qualify if:
- Males and females, healthy adults age 18-55 years, with normal gait.
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Spaulding Rehabilitation Hospital Boston
Boston, Massachusetts, 02129, United States
Limitations and Caveats
The study was based on pilot experiments (N=35) aimed to determine how to use the robot to perturb step length and step height during gait. In the actual study (N=15), the investigators assessed how individuals adapted to the perturbations.
Results Point of Contact
- Title
- Paolo Bonato
- Organization
- Spaulding Rehabilitation Hospital
Study Officials
- PRINCIPAL INVESTIGATOR
Paolo Bonato, PhD
Spaulding Rehabilitation Hospital
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- BASIC SCIENCE
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Director, Motion Analysis Laboratory
Study Record Dates
First Submitted
May 25, 2011
First Posted
May 27, 2011
Study Start
November 1, 2009
Primary Completion
June 1, 2015
Study Completion
June 1, 2015
Last Updated
May 30, 2017
Results First Posted
May 30, 2017
Record last verified: 2017-05
Data Sharing
- IPD Sharing
- Will not share