Ankle Robotics Training After Stroke

Ankle Robotics Training After Stroke: Effects on Gait and Balance

Veterans and other Americans who survive stroke often face disabling motor impairments that impede performance of activities of daily living and limit free-living activity. Prominent among these are diminished walking and balance functions, which not only foster a sedentary lifestyle and physical deconditioning, but also increase the risk of injuries due to falls. Recent research has demonstrated how motor learning based interventions can modify brain activity and improve motor functions in persons with stroke. Now there is a major research opportunity to advance the effectiveness of these interventions by applying new robotics technologies to improve control of essential functions such as gait and balance. One critical area for performance of walking and standing balance is the control of the ankles, as they are a major conduit of mechanical power in gait and also modulate torques affecting the motion of the whole body center of mass when balancing. Thus the current proposal is designed to investigate two approaches for using an impedance controlled ankle robot to improve gait and balance among stroke survivors with chronic lower extremity weakness. One approach uses the ankle robot in a seated visuomotor training program that focuses has subjects play video games with the weaker ankle to improve paretic ankle motor control that may carry over to gait and balance functions. The other approach uses task-specific gait training by integrating use of the ankle robot during treadmill exercise training to assess effects on the same functions. The effectiveness of both robotics approaches will be compared to that of a treadmill exercise program without robotics.

Study Overview

• Status: Completed
• Conditions: Seated Treadmill Training; Treadmill Locomotor-based Training; Treadmill Only
• Intervention / Treatment: Behavioral: Seated Robot Training (SRT); Behavioral: Treadmill Locomotor-based Training (TMR); Behavioral: Treadmill Only (TMO)

Detailed Description

Veterans and other Americans who survive stroke often face disabling motor impairments that impede performance of activities of daily living and limit free-living activity. Prominent among these are diminished locomotor function and impaired balance that not only foster a sedentary lifestyle and physical deconditioning, but also increase the risk injuries due to falls. Recent research has demonstrated how motor learning based interventions can modify brain activity and improve motor functions in persons with stroke. Now there is a major research opportunity to advance the effectiveness of these interventions by applying new robotics technologies to improve neuromotor control of essential functions such as gait and balance. One critical area for performance of walking and standing balance is the control of the ankles, as they are a major conduit of mechanical power in gait and also modulate torques affecting the motion of the whole body center of mass when balancing. Thus the current proposal is designed to investigate two approaches for using an impedance controlled ankle robot to improve gait and balance function among stroke survivors with chronic lower extremity hemiparesis. One approach uses the ankle robot in a seated visuomotor training program that focuses on improving paretic ankle motor control that may transfer to gait and balance functions. The other approach follows the dominant rehabilitation paradigm of task-specific training by integrating use of the ankle robot during treadmill exercise training to assess effects on the same outcomes. The effectiveness of both robotics approaches will be compared to that of a treadmill exercise program without robotics.

The study tests the hypothesis that, in persons with chronic lower extremity hemiparesis, 6 weeks of seated ankle robot training will improve paretic ankle motor control with major improvements in standing balance and moderate improvements in gait, whereas the same amount of training on the treadmill with the ankle robot will improve gait function more than balance. Both robot-trained groups will outperform the treadmill only group on balance, while the treadmill + robot group will make the greatest gains in gait and the seated robot group will make some improvement in gait but will show greater gains in ankle motor control and balance.

Aims: In a 6-week intervention (18 sessions) with persons with chronic lower extremity hemiparesis 1) Compare effects of seated visuomotor ankle robot training vs. treadmill + robot training on paretic ankle impairments and motor control; 2) Compare effects of seated-robot vs. treadmill + robot training on functional mobility and balance outcomes; and 3) Compare the effectiveness of both robotics approaches to a standard treadmill exercise protocol of the same duration. This proposal will establish the initial comparative efficacy of two motor learning based approaches using a modular impedance controlled ankle robot and contrast motor control and functional gait and balance outcomes among them. As a pilot study we also will establish initial deficit profiles for users that respond to each intervention across the 6-week period.

• Study Type: Interventional
• Enrollment (Actual): 41
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Maryland
    • Baltimore, Maryland, United States, 21201
      • Baltimore VA Medical Center VA Maryland Health Care System, Baltimore, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Ischemic or hemorrhagic stroke >6 months prior in men or women aged between 18-80 years.
• Clear indications of hemiparetic gait by clinical observation.
• Completed all conventional physical therapy.
• Ability to walk on a treadmill with handrail support.

Exclusion Criteria:

• Cardiac history of (a) unstable angina, (b) recent (less than 3 months) myocardial infarction, congestive heart failure (NYHA category II); (c) hemodynamically significant valvular dysfunction.
• Major clinical depression: CESD score > 16 and judgment of clinical depression
• Medical History: (a) recent hospitalization (less than 3 months) for severe medical disease, (b) symptomatic peripheral arterial occlusive disease, (c) orthopedic or chronic pain conditions that significantly alter gait function, (d) pulmonary or renal failure (e) active cancer
• History of non-stroke neuromuscular disorder restricting gait.
• Aphasia or cognitive functioning that confounds participation, defined as unable to follow 2 step commands. The Mini Mental State Exam will be administered with a cut-off of less than 23 (less than 17 if education level at or below 8th grade), or judgment of the medical officer.
• Hypertension that is a contraindication for a bout of treadmill training (greater than 160/100 on two assessments).
• Self-report of pregnancy

Study Plan

How is the study designed?

Design Details

• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: SINGLE

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Arm 1; Seated robot training group. Participants at least 6 mos. post-stroke will use the ankle robot in a seated visuo-motor training paradigm. They will train on the robot 3x weekly for 6-weeks (18 sessions) by playing videogames with the paretic ankle. They will be evaluated on outcomes at baseline, post-6 weeks training, and again after a 6-week retention period with no training.	Behavioral: Seated Robot Training (SRT); Participants at least 6 mos. post-stroke will use the ankle robot in a seated visuo-motor training paradigm. They will train on the robot 3x weekly for 6-weeks (18 sessions) by playing videogames with the paretic ankle. They will be evaluated on outcomes at baseline, post-6 weeks training, and again after a 6-week retention period with no training.
EXPERIMENTAL: Arm 2; Treadmill training with ankle robot group. Participants at least 6 mos. post-stroke will wear the ankle robot during treadmill locomotor training. They will walk on a treadmill with the ankle robot adjusted to promote paretic ankle engagement during 3 x weekly training sessions over 6 weeks (18 sessions). They will be evaluated on outcomes at baseline, post-6 weeks training, and again after a 6-week retention period with no training.	Behavioral: Treadmill Locomotor-based Training (TMR); Treadmill training with ankle robot group. Participants at least 6 mos. post-stroke will wear the ankle robot during treadmill locomotor training. They will walk on a treadmill with the ankle robot adjusted to promote paretic ankle engagement during 3 x weekly training sessions over 6 weeks (18 sessions). They will be evaluated on outcomes at baseline, post-6 weeks training, and again after a 6-week retention period with no training.
ACTIVE_COMPARATOR: Arm 3; Treadmill only group. This group will consist of participants at least 6 mos. post-stroke who engage in treadmill training 3x weekly for 6 weeks without robotic support. They will be volunteers from another treadmill training study and evaluated on outcomes at baseline and post-6 weeks training. They will not receive retention testing at 12 weeks because they will be continuing with regular treadmill training beyond the 6-week period.	Behavioral: Treadmill Only (TMO); Treadmill only group. This group will consist of participants at least 6 mos. post-stroke who engage in treadmill training 3x weekly for 6 weeks without robotic support. They will be volunteers from another treadmill training study and evaluated on outcomes at baseline and post-6 weeks training. They will not receive retention testing at 12 weeks because they will be continuing with regular treadmill training beyond the 6-week period.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Self-selected Floor Walking Velocity Change From Baseline to Post-training and Retention	Velocity and associated spatio-temporal gait parameters from self-selected most comfortable and fastest floor walking over 10m.	Baseline, Post-test training at 6 weeks; Retention at 12 weeks (note TMO control has no retention period)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Gait Kinetics	Anterior-posterior and medio-lateral ground reaction forces during walking to assess propulsive impulses from paretic and nonparetic sides.	Baseline, Post-test training at 6 weeks; Retention at 12 weeks (note TMO control has no retention period)
Berg Balance Scale	14-item scale to assess balance function and fall risk, 56 is top score possible (0-56); higher scores indicate higher balance function. Items assess static and dynamic activities of varying difficulty; they are performed to evaluate global level of balance function. Item-level scores range from 0-4, determined by ability to perform the assessed activity; item scores are summed to create the overall score. Subscales are not analyzed.	Baseline, Post-test training at 6 weeks; Retention at 12 weeks (note TMO control has no retention period)
Dynamic Gait Index	The Dynamic Gait Index (DGI) assesses individual's ability to modify balance while walking in the presence of external demands. Performed with a marked distance of 20 feet . The DGI can be performed with or without an assistive device. Scores are based on a 4-point scale: 3 = No gait dysfunction; 2 = Minimal impairment; 1 = Moderate impairment; 0 = Severe impairment. The highest possible score is 24 points. asks include: Steady state walking; Walking with changing speeds; Walking with head turns both horizontally and vertically; Walking while stepping over and around obstacles; Pivoting while walking; Stair climbing.	Baseline, Post-test training at 6 weeks; Retention at 12 weeks (note TMO control has no retention period)
Anticipatory Postural Adjustments	During gait initiation two force plates measure ground reaction forces and impulses for the postural shifts made in preparation to begin walking.	Baseline, Post-test training at 6 weeks; Retention at 12 weeks (note TMO control has no retention period)

Collaborators and Investigators

• Sponsor: US Department of Veterans Affairs
• Investigators: Principal Investigator: Larry W Forrester, PhD, VA Maryland Health Care System, Baltimore

Publications and helpful links

General Publications

• Forrester LW, Roy A, Hafer-Macko C, Krebs HI, Macko RF. Task-specific ankle robotics gait training after stroke: a randomized pilot study. J Neuroeng Rehabil. 2016 Jun 2;13(1):51. doi: 10.1186/s12984-016-0158-1.

Study record dates

Study Major Dates

• Study Start: July 1, 2011
• Primary Completion (ACTUAL): March 1, 2014
• Study Completion (ACTUAL): September 1, 2014

Study Registration Dates

• First Submitted: April 15, 2011
• First Submitted That Met QC Criteria: April 18, 2011
• First Posted (ESTIMATE): April 19, 2011

Study Record Updates

• Last Update Posted (ESTIMATE): June 12, 2015
• Last Update Submitted That Met QC Criteria: May 27, 2015
• Last Verified: May 1, 2015

More Information

Terms related to this study

• Keywords: Stroke; Robotics; Neurorehabilitation
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Stroke
• Other Study ID Numbers: A7461-P