search
Back to results

Pelvic Obliquity Rehabilitation in Stroke Patients Using Robotically Generated Force Fields

Primary Purpose

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

Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Robotic Gait Rehabilitation (RGR) Trainer
Sponsored by
Spaulding Rehabilitation Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Gait Re-training in Healthy Subjects focused on measuring Stroke, Gait, Rehabilitation

Eligibility Criteria

30 Years - 70 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Spaulding Rehabilitation Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Healthy

Post-stroke

Arm Description

Healthy individuals

Chronic stroke survivors

Outcomes

Primary Outcome Measures

Pelvic obliquity
Change in pelvic obliquity during gait consequent to force application

Secondary Outcome Measures

Full Information

First Posted
September 10, 2012
Last Updated
April 3, 2019
Sponsor
Spaulding Rehabilitation Hospital
Collaborators
Northeastern University
search

1. Study Identification

Unique Protocol Identification Number
NCT01684267
Brief Title
Pelvic Obliquity Rehabilitation in Stroke Patients Using Robotically Generated Force Fields
Official Title
Pelvic Obliquity Rehabilitation in Stroke Patients Using Robotically Generated Force Fields
Study Type
Interventional

2. Study Status

Record Verification Date
April 2019
Overall Recruitment Status
Terminated
Why Stopped
Lack of funding
Study Start Date
January 2012 (undefined)
Primary Completion Date
May 2016 (Actual)
Study Completion Date
May 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Spaulding Rehabilitation Hospital
Collaborators
Northeastern University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gait Re-training in Healthy Subjects, Gait Re-training in Stroke Survivors
Keywords
Stroke, Gait, Rehabilitation

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
23 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Healthy
Arm Type
Experimental
Arm Description
Healthy individuals
Arm Title
Post-stroke
Arm Type
Experimental
Arm Description
Chronic stroke survivors
Intervention Type
Device
Intervention Name(s)
Robotic Gait Rehabilitation (RGR) Trainer
Primary Outcome Measure Information:
Title
Pelvic obliquity
Description
Change in pelvic obliquity during gait consequent to force application
Time Frame
1 day

10. Eligibility

Sex
All
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Facility Information:
Facility Name
Spaulding Rehabilitation Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02129
Country
United States

12. IPD Sharing Statement

Learn more about this trial

Pelvic Obliquity Rehabilitation in Stroke Patients Using Robotically Generated Force Fields

We'll reach out to this number within 24 hrs