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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).
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Robot-induced perturbations | Other | The 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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) |
| Measure | Description | Time Frame |
|---|---|---|
| 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) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Paolo Bonato, PhD | Spaulding Rehabilitation Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Spaulding Rehabilitation Hospital Boston | Boston | Massachusetts | 02129 | United States |
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Healthy subjects were recruited by posting flyers in public areas and by contacting subjects who had previously expressed interest for volunteering in research studies in our laboratory.
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| ID | Title | Description |
|---|---|---|
| FG000 | Robot-induced Perturbations | The 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. 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Robot-induced Perturbations | The 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. 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Step Length Adaptation | The percentage of the step length change caused by the mechanical perturbation that subjects compensate for | Posted | Mean | Standard Error | % of step length compensated for | within a trial of the experiment (i.e. a few minutes) |
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Through study completion (three sessions over a period of one week).
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Robot-induced Perturbations | The 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. 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. |
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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.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Paolo Bonato | Spaulding Rehabilitation Hospital | 617-952-6319 | pbonato@partners.org |
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| Participants |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Count of Participants | Participants |
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| Step Length | Please notice that step length was defined as the maximum value of the foot position in the anteroposterior direction in a coordinate system positioned at the center of rotation of the robotic joint connecting the pelvis and thigh components of the exoskeleton system. In other words, this measure differs from standard measures of step length during overground walking. | Mean | Standard Deviation | cm |
|
| Step Height | Please notice that step height was defined as the distance between the foot and the belt of the treadmill during the midswing phase of the gait cycle. This definition of step height allowed us to measure it where the effect of the perturbation led to a maximum deviation from the baseline value | Mean | Standard Deviation | cm |
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| Participants |
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| Secondary | Step Height Adaptation | The percentage of the step height change caused by the mechanical perturbation that subjects compensate for | Posted | Mean | Standard Error | % step height compensated for | within a trial of the experiment (i.e. a few minutes) |
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| 0 |
| 15 |
| 0 |
| 15 |
| 0 |
| 15 |
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