Pelvic Obliquity Rehabilitation in Stroke Patients Using Robotically Generated Force Fields

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.

Study Overview

• Status: Terminated
• Conditions: Gait Re-training in Healthy Subjects; Gait Re-training in Stroke Survivors
• Intervention / Treatment: Device: Robotic Gait Rehabilitation (RGR) Trainer

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.

• Study Type: Interventional
• Enrollment (Actual): 23
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Massachusetts
    • Boston, Massachusetts, United States, 02129
      • Spaulding Rehabilitation Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 30 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Healthy; Healthy individuals	Device: Robotic Gait Rehabilitation (RGR) Trainer
Experimental: Post-stroke; Chronic stroke survivors	Device: Robotic Gait Rehabilitation (RGR) Trainer

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pelvic obliquity	Change in pelvic obliquity during gait consequent to force application	1 day

Collaborators and Investigators

• Sponsor: Spaulding Rehabilitation Hospital
• Collaborators: Northeastern University

Study record dates

Study Major Dates

• Study Start: January 1, 2012
• Primary Completion (Actual): May 1, 2016
• Study Completion (Actual): May 1, 2016

Study Registration Dates

• First Submitted: September 10, 2012
• First Submitted That Met QC Criteria: September 10, 2012
• First Posted (Estimate): September 12, 2012

Study Record Updates

• Last Update Posted (Actual): April 5, 2019
• Last Update Submitted That Met QC Criteria: April 3, 2019
• Last Verified: April 1, 2019

More Information

Terms related to this study

• Keywords: Rehabilitation; Stroke; Gait
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Stroke
• Other Study ID Numbers: 2009-P-000447

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No