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TREAT Foot Drop After Stroke With Ankle Robot (TREAT)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04137809
Recruitment Status : Withdrawn (Study withdrawn due to logistical and safety concerns relating to Covid-19.)
First Posted : October 24, 2019
Last Update Posted : September 11, 2020
Sponsor:
Collaborator:
University of Maryland, Baltimore
Information provided by (Responsible Party):
NextStep Robotics Inc.

Brief Summary:

Researchers at the University of Maryland Rehabilitation and Orthopaedic Institute are looking for individuals who have suffered a stroke and have leg and ankle weakness (foot-drop), to participate in a pilot study to examine the safety and effectiveness of an ankle robot walking program on walking function

This is the first in human test of walking training over-ground using a wearable, lightweight, battery operated ankle robot exoskeleton; with assistance by trained research personnel for safety. This exercise device is aimed at assisting the foot during walking to reduce foot drop and improve walking safety in chronic, mild to moderately impaired stroke survivors who have foot drop.

Possible risks of participating in this study are described in this document. The greatest risks include the risk of falling, muscle soreness, skin irritation, or cardiovascular complications. Before starting, you will have a medical history and medical assessments performed to determine if this study is safe for you. All sessions will be assisted by trained research personnel under supervision of a physical therapist, with medical personnel locally on call.


Condition or disease Intervention/treatment Phase
Foot Drop Stroke Hemiparesis Device: AMBLE Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: TREAT Foot Drop After Stroke With Ankle Robot
Estimated Study Start Date : April 2020
Estimated Primary Completion Date : August 2020
Estimated Study Completion Date : August 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Foot Health

Arm Intervention/treatment
Experimental: Robot Group
1-arm study where eligible volunteers will undergo robotic testing for safety, comfort, and fit.
Device: AMBLE
Treadmill walking while wearing AMBLE device; three times a week for two weeks; 45-60 minutes per session.




Primary Outcome Measures :
  1. Participant report as to whether they are comfortable wearing the device while walking (5 point Likert Scale) [ Time Frame: Change from Baseline at both 2 Weeks and at 8 Weeks ]
    The Likert questionnaire will consist of items related to self-reported measures of comfort including the presence of any abrasions on skin, musculoskeletal issues such as pain resulting from pinch points, and other issues related to overall discomfort.

  2. 10-meter Walk Test [ Time Frame: Change from Baseline at both 2 Weeks and at 8 Weeks ]
    Time(seconds) is measured while the individual walks 10 meters.

  3. 6-minute Walk Test [ Time Frame: Change from Baseline at both 2 Weeks and at 8 Weeks ]
    Assesses distance (meters) walked over 6 minutes.

  4. Presence of Swing Plantar-flexion [ Time Frame: Change from Baseline at both 2 Weeks and at 8 Weeks ]
    Number of subjects with swing plantar-flexion as assessed by a blinded physical therapist assessment through video recording.

  5. Donning/Doffing Time [ Time Frame: Baseline ]
    Average time (minutes) for donning/doffing the device per subject over the course of intervention.

  6. Average Time of Use [ Time Frame: Chang from Baseline at 2 Weeks ]
    Average time (hours) of device use per subject over the course of intervention.


Secondary Outcome Measures :
  1. Berg Balance Scale [ Time Frame: Change from Baseline at both 2 Weeks and at 8 Weeks ]
    A 14-item objective measure designed to assess static balance and fall risk; ranges from 0-56; higher score is better.

  2. Dynamic Gait Index [ Time Frame: Change from Baseline at both 2 Weeks and at 8 Weeks ]
    Assesses gait, balance, and fall risk; ranges from 0-24; higher score is better.

  3. Swing Dorsiflexion [ Time Frame: Change from Baseline at both 2 Weeks and at 8 Weeks ]
    Peak swing dorsiflexion averaged across each gait cycle for each subject at a given testing time point.

  4. Angle at Initial Contact [ Time Frame: Change from Baseline at both 2 Weeks and at 8 Weeks ]
    Angle at initial contact averaged across each gait cycle for each subject at a given testing time point.

  5. Number of Heel-First Foot Strikes [ Time Frame: Change from Baseline at both 2 Weeks and at 8 Weeks ]
    Number of heel-first foot strikes for each subject at a given testing time point.

  6. Number of Participants Using Assistive Devices and Ankle Foot Orthoses [ Time Frame: Change from Baseline at both 2 Weeks and at 8 Weeks ]
    Number of Participants Using Assistive Devices and Ankle Foot Orthoses.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   21 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Age 21-75 years
  • Greater than 3 months post stroke
  • Hemiparetic stroke with foot drop (Dorsiflexion deficit)
  • Dorsiflexion deficit for active range of motion (unable to reach zero degrees)
  • Dorsiflexion deficit for strength with a manual motor score between 1/5 and 4/5
  • Mild-moderate severity hemiparetic gait, identified by reduced stance, or reduced stance plus increased swing on affected side
  • Able to participate in physical therapy for mobility recovery, defined by capacity to walk 10-m over-ground, albeit with minimal assist (FIM Mobility Subscale 4; subject can perform 75% of the task), supervision (FIM Mobility Score 5) or modified independence (FIM Mobility Score 6; use an assistive device)
  • Adequate language and cognitive function to participate in routine mobility physical therapy

Exclusion Criteria:

  • Cardiac history of unstable angina, recent (<3 mos.) myocardial infarction, congestive heart failure, significant valvular dysfunction
  • Hypertension contraindicating rehabilitation (>160/100, two assessments)
  • Peripheral arterial occlusive disease (Fontaine II)
  • Orthopedic/chronic pain conditions precluding robot use
  • Pulmonary or renal failure or active cancer
  • Non-stroke neuromuscular or neurological conditions that restrict gait or could confound interpretation of key outcomes
  • Aphasia, unable to follow 2 step commands, or communicate pain, discomfort, or sufficiently interact with PT/staff to participate in PT or PTR treatment assignments, as per judgment of a credentialed clinician
  • Cognitive dysfunction that confounds participation, including diagnosis of dementia including Alzheimer's Disease and Alzheimer's Related Disorders, or active delirium (as defined by Diagnostic and Statistical Manual of Mental Disorders (DSM- 5));
  • Modified Ashworth Spasticity >3 (considerable increase in muscle tone, passive movement difficult) or contractures that preclude adequate volitional range of motion (ROM) for motor learning
  • Foot and lower leg pain or deformities that complicate safe and effective robot fit
  • Active deep venous thrombosis
  • Skin lesions, infections, other cutaneous or musculoskeletal conditions of the shank that would complicate robot attachment to the leg
  • Untreated and active major depression

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04137809


Locations
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United States, Maryland
UM Rehabilitation & Orthopaedic Institute
Baltimore, Maryland, United States, 21207
Sponsors and Collaborators
NextStep Robotics Inc.
University of Maryland, Baltimore
Investigators
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Principal Investigator: Richard Macko, MD University of Maryland, College Park
Study Director: Bradley Hennessie, MHA,MBA NextStep Robotics Inc.
Publications:
Hogan N. Impedance Control: An Approach to Manipulation: Part I-Theory. ASME. J. Dyn. Sys., Meas., Control. 1985;107(1):1-7.
Olney SJ, Richards C. Hemiparetic gait following stroke. Part I: Characteristics. Gait Posture. 1996; 4:136-48.
Roy A, Krebs HI, Williams DJ, Bever CT, Forrester LW, Macko RF, Hogan N. Robot-aided neurorehabilitation: a robot for ankle rehabilitation. IEEE Trans Robotics. 2009; 25:569-82
Hogan N. Impedance Control: An Approach to Manipulation: Part II-Implementation. ASME. J. Dyn. Sys., Meas., Control. 1985;107(1):8-16
Hogan N. Impedance Control: An Approach to Manipulation: Part III-Applications. ASME. J. Dyn. Sys., Meas., Control. 1985;107(1):17-24.
Kendall FP, McCreary EK, Provance PG, Rodgers MM, Romani WA. Muscles: Testing and function with posture and pain, 5th edition, 2005, Lippincott Williams & Wilkins, Baltimore, MD
Norkin C, White D. Measurement of joint motion: A guide to goniometry, 3rd edition, 2003, FA Davis, Philadelphia, PA.
Roy A, Krebs HI, Barton JE, Macko RF, Forrester LW. Anklebot-assisted locomotor training after stroke: A novel deficit-adjusted control approach. In: Proc 2013 IEEE Int. Conf Rob Auto (ICRA). 2013; 2175-82.
Roy A, Forrester LW, Macko F. Method and apparatus for providing deficit-adjusted adaptive assistance during movement phases of an impaired joint. US Patent 9,943,459, filed November 20, 2014, and issued April 17, 2018.
National Institute of Health, National Institute of Neurological Disorders and Stroke. Stroke Scale. http://www.ninds.nih.gov/doctors/NIH_Stroke_Scale.pdf
Devins, G. M., & Orme, C. M. Center for epidemiologic studies depression scale. Test critiques. 1985; 2: 144-60.
Shumway-Cook A, Woollacott MH. Motor control: Theory and practical applications, 2nd Edition, 2001, Baltimore: Lippincott Williams and Wilkins
Little RJA, Rubin DB. Statistical analysis with missing data. 1987
Armitage P, Berry G, Matthews JNS. Statistical methods in medical research. 2002;4th edition

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Responsible Party: NextStep Robotics Inc.
ClinicalTrials.gov Identifier: NCT04137809    
Other Study ID Numbers: A-7010546431
First Posted: October 24, 2019    Key Record Dates
Last Update Posted: September 11, 2020
Last Verified: September 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: All IPD that underlie results in a publication will be shared.
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Clinical Study Report (CSR)
Time Frame: Data will become available immediately following any and all publications arising from the study.
Access Criteria: Publications can be accessed through journal websites and conference proceedings. This information will be made available to researchers and, more broadly, members of the public.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Stroke
Paresis
Peroneal Neuropathies
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Neurologic Manifestations
Mononeuropathies
Peripheral Nervous System Diseases
Neuromuscular Diseases