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Pelvic Obliquity Rehabilitation in Stroke Patients Using Robotically Generated Force Fields

Pelvic Obliquity Rehabilitation in Stroke Patients Using Robotically Generated Force Fields

Status
Terminated
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01684267
Enrollment
23
Registered
2012-09-12
Start date
2012-01-31
Completion date
2016-05-31
Last updated
2019-04-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Keywords

Stroke, Gait, Rehabilitation

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.

Interventions

DEVICERobotic Gait Rehabilitation (RGR) Trainer

Sponsors

Northeastern University
CollaboratorOTHER
Spaulding Rehabilitation Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
30 Years to 70 Years
Healthy volunteers
Yes

Inclusion 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

Design outcomes

Primary

MeasureTime frameDescription
Pelvic obliquity1 dayChange in pelvic obliquity during gait consequent to force application

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026