Ankle Robotics Training After Stroke

NCT01337960 | Completed Results DMC

• 1 other identifier: A7461-P
• Study Type: interventional
• Target: 41
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Seated Treadmill Training; Treadmill Locomotor-based Training; Treadmill Only

Keywords

Stroke; Robotics; Neurorehabilitation

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Gait Kinetics

  Baseline, Post-test training at 6 weeks; Retention at 12 weeks (note TMO control has no retention period)

• Berg Balance Scale

  Baseline, Post-test training at 6 weeks; Retention at 12 weeks (note TMO control has no retention period)

• Dynamic Gait Index

  Baseline, Post-test training at 6 weeks; Retention at 12 weeks (note TMO control has no retention period)

• Anticipatory Postural Adjustments

  Baseline, Post-test training at 6 weeks; Retention at 12 weeks (note TMO control has no retention period)

Study Arms (3)

Arm 1

EXPERIMENTAL

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)

Arm 2

EXPERIMENTAL

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)

Arm 3

ACTIVE COMPARATOR

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)

Interventions

Seated Robot Training (SRT) BEHAVIORAL

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.

Arm 1

Treadmill Locomotor-based Training (TMR) BEHAVIORAL

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.

Arm 2

Treadmill Only (TMO) BEHAVIORAL

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.

Arm 3

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• US Department of Veterans Affairs: lead

Study Sites (1)

Baltimore VA Medical Center VA Maryland Health Care System, Baltimore, MD

Baltimore, Maryland, 21201, United States

Location

Related Publications (1)

• 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.

  PMID: 27255156 DERIVED

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Limitations and Caveats

The control group was limited in both numbers and the fact that they were not available for retention testing. The technical challenges for reliable collection of anticipatory postural adjustments meant loss of those data for analysis.

Results Point of Contact

• Title: Larry Forrester, PhD
• Organization: VA Maryland Health Care System

Larry.Forrester@va.gov

410-637-3241

Study Officials

• Larry W Forrester, PhD

  VA Maryland Health Care System, Baltimore

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Intervention Model: PARALLEL
• Sponsor Type: FED
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 15, 2011
• First Posted: April 19, 2011
• Study Start: July 1, 2011
• Primary Completion: March 1, 2014
• Study Completion: September 1, 2014
• Last Updated: June 12, 2015
• Results First Posted: June 12, 2015

Record last verified: 2015-05

Locations

US (1)