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

September 10, 2012
March 18, 2014
January 2012
September 2014   (final data collection date for primary outcome measure)
Pelvic obliquity [ Time Frame: 1 day ] [ Designated as safety issue: No ]
Change in pelvic obliquity during gait consequent to force application
Same as current
Complete list of historical versions of study NCT01684267 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Pelvic Obliquity Rehabilitation in Stroke Patients Using Robotically Generated Force Fields
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.

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.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Gait Re-training in Healthy Subjects
  • Gait Re-training in Stroke Survivors
Device: Robotic Gait Rehabilitation (RGR) Trainer
  • Experimental: Healthy
    Healthy individuals
    Intervention: Device: Robotic Gait Rehabilitation (RGR) Trainer
  • Experimental: Post-stroke
    Chronic stroke survivors
    Intervention: Device: Robotic Gait Rehabilitation (RGR) Trainer
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
30
December 2014
September 2014   (final data collection date for primary outcome measure)

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
Both
30 Years to 70 Years
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01684267
2009-P-000447
No
Paolo Bonato, Spaulding Rehabilitation Hospital
Spaulding Rehabilitation Hospital
Northeastern University
Not Provided
Spaulding Rehabilitation Hospital
March 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP