Trial Outcomes & Findings for Robotic Assessment of Lower Extremity Motor Learning (NCT NCT01361867)

NCT ID: NCT01361867

Last Updated: 2017-05-30

Results Overview

The percentage of the step length change caused by the mechanical perturbation that subjects compensate for

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

15 participants

Primary outcome timeframe

within a trial of the experiment (i.e. a few minutes)

Results posted on

2017-05-30

Participant Flow

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.

Participant milestones

Participant milestones
Measure
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.
Overall Study
STARTED
15
Overall Study
COMPLETED
15
Overall Study
NOT COMPLETED
0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Robotic Assessment of Lower Extremity Motor Learning

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
Robot-induced Perturbations
n=15 Participants
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.
Age, Categorical
<=18 years
0 Participants
n=5 Participants
Age, Categorical
Between 18 and 65 years
15 Participants
n=5 Participants
Age, Categorical
>=65 years
0 Participants
n=5 Participants
Sex: Female, Male
Female
6 Participants
n=5 Participants
Sex: Female, Male
Male
9 Participants
n=5 Participants
Ethnicity (NIH/OMB)
Hispanic or Latino
2 Participants
n=5 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
13 Participants
n=5 Participants
Ethnicity (NIH/OMB)
Unknown or Not Reported
0 Participants
n=5 Participants
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants
n=5 Participants
Race (NIH/OMB)
Asian
0 Participants
n=5 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants
n=5 Participants
Race (NIH/OMB)
Black or African American
0 Participants
n=5 Participants
Race (NIH/OMB)
White
15 Participants
n=5 Participants
Race (NIH/OMB)
More than one race
0 Participants
n=5 Participants
Race (NIH/OMB)
Unknown or Not Reported
0 Participants
n=5 Participants
Region of Enrollment
United States
15 Participants
n=5 Participants
Step Length
25.0 cm
STANDARD_DEVIATION 0.3 • n=5 Participants
Step Height
9.7 cm
STANDARD_DEVIATION 0.2 • n=5 Participants

PRIMARY outcome

Timeframe: within a trial of the experiment (i.e. a few minutes)

The percentage of the step length change caused by the mechanical perturbation that subjects compensate for

Outcome measures

Outcome measures
Measure
Robot-induced Perturbations
n=15 Participants
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.
Step Length Adaptation
83.6 % of step length compensated for
Standard Error 4.5

SECONDARY outcome

Timeframe: within a trial of the experiment (i.e. a few minutes)

The percentage of the step height change caused by the mechanical perturbation that subjects compensate for

Outcome measures

Outcome measures
Measure
Robot-induced Perturbations
n=15 Participants
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.
Step Height Adaptation
6.1 % step height compensated for
Standard Error 4.1

Adverse Events

Robot-induced Perturbations

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Paolo Bonato

Spaulding Rehabilitation Hospital

Phone: 617-952-6319

Results disclosure agreements

  • Principal investigator is a sponsor employee
  • Publication restrictions are in place