Ankle Robot to Reduce Foot Drop in Stroke
Primary Purpose
Stroke, Foot Drop
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Treadmill plus anklebot
Treadmill only
Sponsored by
About this trial
This is an interventional treatment trial for Stroke focused on measuring Rehabilitation, Robotics, Gait
Eligibility Criteria
Inclusion Criteria:
- Ischemic or hemorrhagic stroke > 2 months prior in men or women
- Residual hemiparesis of the lower extremity that includes symptoms of foot drop
- Capable of ambulating on a treadmill with handrail support
- Already completed all conventional physical therapy
- Adequate language and cognitive function to provide informed consent and participate in testing and training
Exclusion Criteria:
Cardiac history of:
- Unstable angina
- Recent (< 3 months) myocardial infarction
- Congestive heart failure (NYHA category II or higher)
- Hemodynamic valvular dysfunction
- Hypertension that is a contraindication for a bout of treadmill training (>160/100 mmHg on two assessments)
Medical history of:
- Recent hospitalization (< 3 months) for any serious condition leading to significant bed-rest or reduction in mobility function
- Symptomatic peripheral arterial occlusive disease
- Orthopedic or chronic pain conditions restricting exercise
- Pulmonary failure requiring oxygen
- Uncompensated renal failure
- Active cancer
Neurological history and exam consistent with:
- Dementia
- Receptive or global aphasia that confounds testing and training, operationally defined as unable to follow 2-point commands
- Non-stroke neurological disorder restricting exercise (e.g. Parkinson's Syndrome, myopathy)
- Untreated major depression
Sites / Locations
- Baltimore VA Medical Center VA Maryland Health Care System, Baltimore, MD
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Treadmill+anklebot
Treadmill only
Arm Description
This group will receive gait training on a treadmill while wearing the anklebot with the adaptive control system.
This group will receive gait training on a treadmill, without use of the anklebot.
Outcomes
Primary Outcome Measures
Gait Velocity During Self-selected Overground Walking
Gait velocity during self-selected overground walking measured in cm/sec
Anterior-posterior Propulsion Forces of Paretic Side During Gait
Newtons: anterior-posterior force generated during push-off phase of the gait cycle
Peak Dorsiflexion Angle During Swing Phase of Gait
Degrees; extent of ankle dorsiflexion to enable foot clearance
Postural Sway Areas During Quiet Standing
cm^2; extent of postural deviations to assess static postural control
Ratio of Asymmetric Loading in Quiet Standing
Ratio of Newtons of force per each leg (paretic/nonparetic) while standing quietly
Peak Paretic Push Off Forces During Gait Initiation
Newtons; magnitude of forward ground reaction forces
Secondary Outcome Measures
Full Information
NCT ID
NCT02483676
First Posted
June 19, 2015
Last Updated
May 8, 2020
Sponsor
VA Office of Research and Development
1. Study Identification
Unique Protocol Identification Number
NCT02483676
Brief Title
Ankle Robot to Reduce Foot Drop in Stroke
Official Title
Adaptive Ankle Robot Control System to Reduce Foot-drop in Chronic Stroke
Study Type
Interventional
2. Study Status
Record Verification Date
May 2020
Overall Recruitment Status
Completed
Study Start Date
September 1, 2015 (Actual)
Primary Completion Date
April 1, 2019 (Actual)
Study Completion Date
June 30, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
VA Office of Research and Development
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
Deficits in ankle control after stroke can lead to foot drop, resulting in inefficient, aberrant gait and an elevated falls risk. Using a novel ankle robot and newly invented adaptive control system, this study tests whether robotic-assisted treadmill training will improve gait and balance functions in chronic stroke survivors with foot drop impairment. It is hypothesized that, compared to treadmill training alone, integrating adaptive ankle robotics with treadmill training will reduce drop foot during independent overground walking, resulting in greater mobility, improved postural control, and reduced fall risk.
Detailed Description
This proposal investigates a novel ankle robot (anklebot) adaptive control approach integrated with treadmill training to reduce foot drop and improve mobility function in chronic hemiparetic stroke survivors. Currently, stroke survivors with foot drop are trained to live with a cane or other assistive device, and often ankle foot orthotics (AFOs) for safety. Neither mediates task-practice or neuromotor recovery.
The investigators have developed an adaptive anklebot controller that detects gait cycle sub-events for precise timing of graded robotics assistance to enable deficit severity-adjusted ankle motor learning in the context of walking. The investigators' pilot findings show that 6 weeks treadmill training with anklebot (TMR) timed to assist swing phase dorsiflexion only is more effective than treadmill alone (TM) to improve free-walking swing dorsiflexion at foot strike, floor-walking speed, and the benefits are retained at 6 weeks post-training. Notably, swing-phase TMR training improved paretic leg push-off, and reduced center-of-pressure sway on standing balance, indicating potential benefits to other elements of gait and balance, beyond those robotically targeted toward foot drop.
This randomized study investigates the hypothesis that 6 weeks TMR is more effective to improve durably gait biomechanics, static, and dynamic balance, and mobility function in chronic stroke survivors with dorsiflexion deficits, compared to TM alone. Aims are to determine the compare effectiveness of 6 weeks TMR vs. TM alone on:
Independent gait function indexed by gait velocity, swing-phase DF (dorsiflexion), terminal stance push-off.
Balance function indexed by measures of postural sway (CoP), asymmetric loading in quiet standing, peak paretic A-P forces in non-paretic gait initiation, and standardized scales for balance and fall risk.
Long-term mobility outcomes, assessed by repeated measures of all key gait and balance outcomes at 6 weeks and 3 months after formal training cessation.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke, Foot Drop
Keywords
Rehabilitation, Robotics, Gait
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
45 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Treadmill+anklebot
Arm Type
Experimental
Arm Description
This group will receive gait training on a treadmill while wearing the anklebot with the adaptive control system.
Arm Title
Treadmill only
Arm Type
Active Comparator
Arm Description
This group will receive gait training on a treadmill, without use of the anklebot.
Intervention Type
Device
Intervention Name(s)
Treadmill plus anklebot
Other Intervention Name(s)
TMR
Intervention Description
This intervention employs the use of the adaptive anklebot control system to complement treadmill exercise training over a 6-week intervention period.
Intervention Type
Behavioral
Intervention Name(s)
Treadmill only
Other Intervention Name(s)
TM
Intervention Description
This intervention employs the use of a treadmill for gait exercise training over a 6-week intervention period
Primary Outcome Measure Information:
Title
Gait Velocity During Self-selected Overground Walking
Description
Gait velocity during self-selected overground walking measured in cm/sec
Time Frame
Change from baseline to: Post 6-week training, 6 weeks after completion, and 3 (or 6) months after completion
Title
Anterior-posterior Propulsion Forces of Paretic Side During Gait
Description
Newtons: anterior-posterior force generated during push-off phase of the gait cycle
Time Frame
Change from baseline to: Post 6-weeks training, 6 weeks after completion, and 3 (or 6) months
Title
Peak Dorsiflexion Angle During Swing Phase of Gait
Description
Degrees; extent of ankle dorsiflexion to enable foot clearance
Time Frame
Change from baseline to: Post 6-week training, 6 weeks after completion, and 3 (or 6) months after completion
Title
Postural Sway Areas During Quiet Standing
Description
cm^2; extent of postural deviations to assess static postural control
Time Frame
Change from baseline to: Post 6-week training, 6 weeks after completion, and 3 (or 6) months
Title
Ratio of Asymmetric Loading in Quiet Standing
Description
Ratio of Newtons of force per each leg (paretic/nonparetic) while standing quietly
Time Frame
Change from baseline to: Post 6-week training, 6 weeks after completion, and 3 (or 6) months
Title
Peak Paretic Push Off Forces During Gait Initiation
Description
Newtons; magnitude of forward ground reaction forces
Time Frame
Change from baseline to: Post 6-week training, 6 weeks after completion, and 3 (or 6) months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Ischemic or hemorrhagic stroke > 2 months prior in men or women
Residual hemiparesis of the lower extremity that includes symptoms of foot drop
Capable of ambulating on a treadmill with handrail support
Already completed all conventional physical therapy
Adequate language and cognitive function to provide informed consent and participate in testing and training
Exclusion Criteria:
Cardiac history of:
Unstable angina
Recent (< 3 months) myocardial infarction
Congestive heart failure (NYHA category II or higher)
Hemodynamic valvular dysfunction
Hypertension that is a contraindication for a bout of treadmill training (>160/100 mmHg on two assessments)
Medical history of:
Recent hospitalization (< 3 months) for any serious condition leading to significant bed-rest or reduction in mobility function
Symptomatic peripheral arterial occlusive disease
Orthopedic or chronic pain conditions restricting exercise
Pulmonary failure requiring oxygen
Uncompensated renal failure
Active cancer
Neurological history and exam consistent with:
Dementia
Receptive or global aphasia that confounds testing and training, operationally defined as unable to follow 2-point commands
Non-stroke neurological disorder restricting exercise (e.g. Parkinson's Syndrome, myopathy)
Untreated major depression
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Steven J Kittner
Organizational Affiliation
Baltimore VA Medical Center VA Maryland Health Care System, Baltimore, MD
Official's Role
Principal Investigator
Facility Information:
Facility Name
Baltimore VA Medical Center VA Maryland Health Care System, Baltimore, MD
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21201
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Ankle Robot to Reduce Foot Drop in Stroke
We'll reach out to this number within 24 hrs