Pelvic Obliquity Rehabilitation in Stroke Patients Using Robotically Generated Force Fields

NCT ID: NCT01684267

Last Updated: 2019-04-05

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 23 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-01-31
• Study Completion Date: 2016-05-31

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.

Conditions

Gait Re-training in Healthy Subjects; Gait Re-training in Stroke Survivors

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Healthy

Healthy individuals

Group Type: EXPERIMENTAL

Robotic Gait Rehabilitation (RGR) Trainer

Intervention Type: DEVICE

Post-stroke

Chronic stroke survivors

Group Type: EXPERIMENTAL

Robotic Gait Rehabilitation (RGR) Trainer

Intervention Type: DEVICE

Interventions

Robotic Gait Rehabilitation (RGR) Trainer

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• Can walk comfortably on a treadmill

• 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

• 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

• 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

• Minimum Eligible Age: 30 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Northeastern University

OTHER

Sponsor Role: collaborator

Spaulding Rehabilitation Hospital

OTHER

Sponsor Role: lead

Responsible Party

Paolo Bonato

Director, Motion Analysis Laboratory

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Spaulding Rehabilitation Hospital

Boston, Massachusetts, United States

Countries

United States

Other Identifiers

2009-P-000447

Identifier Type: -

Identifier Source: org_study_id