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Clinical Trials/NCT01684267
NCT01684267
Terminated
Not Applicable

Pelvic Obliquity Rehabilitation in Stroke Patients Using Robotically Generated Force Fields

Spaulding Rehabilitation Hospital1 site in 1 country23 target enrollmentJanuary 2012

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Gait Re-training in Healthy Subjects
Sponsor
Spaulding Rehabilitation Hospital
Enrollment
23
Locations
1
Primary Endpoint
Pelvic obliquity
Status
Terminated
Last Updated
7 years ago

Overview

Brief 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.

Detailed 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.

Registry
clinicaltrials.gov
Start Date
January 2012
End Date
May 2016
Last Updated
7 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Sponsor
Spaulding Rehabilitation Hospital
Responsible Party
Principal Investigator
Principal Investigator

Paolo Bonato

Director, Motion Analysis Laboratory

Spaulding Rehabilitation Hospital

Eligibility Criteria

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
  • 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

Outcomes

Primary Outcomes

Pelvic obliquity

Time Frame: 1 day

Change in pelvic obliquity during gait consequent to force application

Study Sites (1)

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