Ankle Robot to Reduce Foot Drop in Stroke

NCT02483676 | Completed Results DMC FDA Device

• 1 other identifier: N1699-R
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 1

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.

Conditions

Stroke; Foot Drop

Keywords

Rehabilitation; Robotics; Gait

Outcome Measures

Primary Outcomes (6)

• Gait Velocity During Self-selected Overground Walking

  Gait velocity during self-selected overground walking measured in cm/sec

  Change from baseline to: Post 6-week training, 6 weeks after completion, and 3 (or 6) months after completion

• Anterior-posterior Propulsion Forces of Paretic Side During Gait

  Newtons: anterior-posterior force generated during push-off phase of the gait cycle

  Change from baseline to: Post 6-weeks training, 6 weeks after completion, and 3 (or 6) months

• Peak Dorsiflexion Angle During Swing Phase of Gait

  Degrees; extent of ankle dorsiflexion to enable foot clearance

  Change from baseline to: Post 6-week training, 6 weeks after completion, and 3 (or 6) months after completion

• Postural Sway Areas During Quiet Standing

  cm\^2; extent of postural deviations to assess static postural control

  Change from baseline to: Post 6-week training, 6 weeks after completion, and 3 (or 6) months

• Ratio of Asymmetric Loading in Quiet Standing

  Ratio of Newtons of force per each leg (paretic/nonparetic) while standing quietly

  Change from baseline to: Post 6-week training, 6 weeks after completion, and 3 (or 6) months

• Peak Paretic Push Off Forces During Gait Initiation

  Newtons; magnitude of forward ground reaction forces

  Change from baseline to: Post 6-week training, 6 weeks after completion, and 3 (or 6) months

Study Arms (2)

Treadmill+anklebot

EXPERIMENTAL

This group will receive gait training on a treadmill while wearing the anklebot with the adaptive control system.

Device: Treadmill plus anklebot

Treadmill only

ACTIVE COMPARATOR

This group will receive gait training on a treadmill, without use of the anklebot.

Behavioral: Treadmill only

Interventions

Treadmill plus anklebot DEVICE

This intervention employs the use of the adaptive anklebot control system to complement treadmill exercise training over a 6-week intervention period.

Also known as: TMR

Treadmill+anklebot

Treadmill only BEHAVIORAL

This intervention employs the use of a treadmill for gait exercise training over a 6-week intervention period

Also known as: TM

Treadmill only

Eligibility Criteria

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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• VA Office of Research and Development: lead

Study Sites (1)

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

Baltimore, Maryland, 21201, United States

Location

MeSH Terms

Conditions

Stroke; Peroneal Neuropathies

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Mononeuropathies; Peripheral Nervous System Diseases; Neuromuscular Diseases

Results Point of Contact

• Title: Dr. Steven Kittner
• Organization: Baltimore VA Medical Center VA Maryland Health Care System

skittner@som.umaryland.edu

410-706-0414

Study Officials

• Steven J Kittner

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

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

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

Study Record Dates

• First Submitted: June 19, 2015
• First Posted: June 29, 2015
• Study Start: September 1, 2015
• Primary Completion: April 1, 2019
• Study Completion: June 30, 2019
• Last Updated: May 20, 2020
• Results First Posted: May 20, 2020

Record last verified: 2020-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)