Overview

This trial is active, not recruiting.

Conditions gait re-training in healthy subjects, gait re-training in stroke survivors
Treatment robotic gait rehabilitation (rgr) trainer
Sponsor Spaulding Rehabilitation Hospital
Collaborator Northeastern University
Start date January 2012
End date January 2018
Trial size 30 participants
Trial identifier NCT01684267, 2009-P-000447

Summary

To test the usability and effectiveness of a robotic device, called the Robotic Gait Rehabilitation (RGR) Trainer, in (1) healthy subjects with no gait impairment and (2) patients with stroke with gait abnormalities secondary to impaired knee function.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model single group assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
Healthy individuals
robotic gait rehabilitation (rgr) trainer
(Experimental)
Chronic stroke survivors
robotic gait rehabilitation (rgr) trainer

Primary Outcomes

Measure
Pelvic obliquity
time frame: 1 day

Eligibility Criteria

Male or female participants from 30 years up to 70 years old.

HEALTHY Inclusion Criteria: - Can walk comfortably on a treadmill Exclusion Criteria: - any known orthopedic, musculoskeletal, neurological, cardiovascular, pulmonary, or gait disorder that results in an abnormal gait pattern - Females in the second or third trimester of pregnancy STROKE Inclusion Criteria: - single non-traumatic ischemic or hemorrhagic stroke at least 6 months prior to enrollment - persistent hemiparesis, mild spasticity, and residual mild-to-moderate weakness of the lower extremity - residual deficits of gait - be able to ambulate without the use of assistive devices or assistance of a person - able to walk at a comfortable walking speed of ~0.6 m/s - able to walk safely on a treadmill - medically stable - No other neurological problems, or any known cardiovascular or musculoskeletal disorders that effects their gait or excludes them from exercise Exclusion Criteria: - unable to attend and follow instructions - require physical assistance for ambulation - other known orthopedic, musculoskeletal, neurological, cardiovascular, pulmonary, or gait disorder that results in an abnormal gait pattern - severe joint contractures of the hemi-paretic knee - females in the second or third trimester of pregnancy

Additional Information

Official title Pelvic Obliquity Rehabilitation in Stroke Patients Using Robotically Generated Force Fields
Description The device is designed to train stroke patients to correct abnormal gait patterns associated with exaggerated and uncoordinated movements of the pelvis by applying force fields to correct the movement of the pelvis. The focus will be on correcting hip hiking (i.e. exaggerated unilateral upward movements of one side of the pelvis) in post-stroke patients. The human-robot interface will be based on impedance control techniques so that the force-field actuators generate smooth virtual spring/damper restitution forces at the patient's pelvic area. As part of the study we will determine whether the force fields applied by the actuated components of the device can effect an acute change in gait biomechanics, primarily pelvis motion during stance and swing phases, in healthy subjects and patients with stroke during ambulation. The investigators will also evaluate the usability of the orthosis in terms of donning & doffing, user confidence, and comfort.
Trial information was received from ClinicalTrials.gov and was last updated in April 2016.
Information provided to ClinicalTrials.gov by Spaulding Rehabilitation Hospital.