Pelvic Obliquity Rehabilitation in Stroke Patients Using Robotically Generated Force Fields

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Northeastern University
Information provided by (Responsible Party):
Paolo Bonato, Spaulding Rehabilitation Hospital
ClinicalTrials.gov Identifier:
NCT01684267
First received: September 10, 2012
Last updated: March 18, 2014
Last verified: March 2014
  Purpose

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.


Condition Intervention
Gait Re-training in Healthy Subjects
Gait Re-training in Stroke Survivors
Device: Robotic Gait Rehabilitation (RGR) Trainer

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Pelvic Obliquity Rehabilitation in Stroke Patients Using Robotically Generated Force Fields

Resource links provided by NLM:


Further study details as provided by Spaulding Rehabilitation Hospital:

Primary Outcome Measures:
  • Pelvic obliquity [ Time Frame: 1 day ] [ Designated as safety issue: No ]
    Change in pelvic obliquity during gait consequent to force application


Estimated Enrollment: 30
Study Start Date: January 2012
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: September 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Healthy
Healthy individuals
Device: Robotic Gait Rehabilitation (RGR) Trainer
Experimental: Post-stroke
Chronic stroke survivors
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.

  Eligibility

Ages Eligible for Study:   30 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01684267

Locations
United States, Massachusetts
Spaulding Rehabilitation Hospital
Boston, Massachusetts, United States, 02129
Sponsors and Collaborators
Spaulding Rehabilitation Hospital
Northeastern University
  More Information

No publications provided

Responsible Party: Paolo Bonato, Director, Motion Analysis Laboratory, Spaulding Rehabilitation Hospital
ClinicalTrials.gov Identifier: NCT01684267     History of Changes
Other Study ID Numbers: 2009-P-000447
Study First Received: September 10, 2012
Last Updated: March 18, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Spaulding Rehabilitation Hospital:
Stroke
Gait
Rehabilitation

Additional relevant MeSH terms:
Stroke
Cerebral Infarction
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Brain Infarction
Brain Ischemia

ClinicalTrials.gov processed this record on July 24, 2014