N/A
N=15
Robotic Assessment of Lower Extremity Motor Learning
Healthy Subjects
Bottom Line
View on ClinicalTrials.gov: NCT01361867 ↗Enrolled (actual)
15
Serious AEs
0.0%
Results posted
May 2017
Primary outcome: Primary: Step Length Adaptation — 83.6 % of step length compensated for
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Robot-induced perturbations (Device)
- Age
- Adult · 18+ yrs
- Sex
- All
- Sponsor
- Spaulding Rehabilitation Hospital
- Primary completion
- Jun 2015
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Step Length Adaptation |
83.6 | — |
| SECONDARY Step Height Adaptation |
6.1 | — |
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).
Eligibility 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 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
Data sourced from ClinicalTrials.gov (NCT01361867). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.