TREAT Foot Drop After Stroke With Ankle Robot

NCT04137809 | Withdrawn DMC

• 1 other identifier: A-7010546431
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Foot Drop; Stroke; Hemiparesis

Outcome Measures

Primary Outcomes (6)

• Participant report as to whether they are comfortable wearing the device while walking (5 point Likert Scale)

  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.

  Change from Baseline at both 2 Weeks and at 8 Weeks

• 10-meter Walk Test

  Time(seconds) is measured while the individual walks 10 meters.

  Change from Baseline at both 2 Weeks and at 8 Weeks

• 6-minute Walk Test

  Assesses distance (meters) walked over 6 minutes.

  Change from Baseline at both 2 Weeks and at 8 Weeks

• Presence of Swing Plantar-flexion

  Number of subjects with swing plantar-flexion as assessed by a blinded physical therapist assessment through video recording.

  Change from Baseline at both 2 Weeks and at 8 Weeks

• Donning/Doffing Time

  Average time (minutes) for donning/doffing the device per subject over the course of intervention.

  Baseline

• Average Time of Use

  Average time (hours) of device use per subject over the course of intervention.

  Chang from Baseline at 2 Weeks

Secondary Outcomes (6)

• Berg Balance Scale

  Change from Baseline at both 2 Weeks and at 8 Weeks

• Dynamic Gait Index

  Change from Baseline at both 2 Weeks and at 8 Weeks

• Swing Dorsiflexion

  Change from Baseline at both 2 Weeks and at 8 Weeks

• Angle at Initial Contact

  Change from Baseline at both 2 Weeks and at 8 Weeks

• Number of Heel-First Foot Strikes

  Change from Baseline at both 2 Weeks and at 8 Weeks

Study Arms (1)

Robot Group

EXPERIMENTAL

1-arm study where eligible volunteers will undergo robotic testing for safety, comfort, and fit.

Device: AMBLE

Interventions

AMBLE DEVICE

Treadmill walking while wearing AMBLE device; three times a week for two weeks; 45-60 minutes per session.

Robot Group

Eligibility Criteria

• Age: 21 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• NextStep Robotics Inc.: lead
• University of Maryland, Baltimore: collaborator

Study Sites (1)

UM Rehabilitation & Orthopaedic Institute

Baltimore, Maryland, 21207, United States

Location

Related Publications (60)

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MeSH Terms

Conditions

Peroneal Neuropathies; Stroke; Paresis

Condition Hierarchy (Ancestors)

Mononeuropathies; Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Richard Macko, MD

  University of Maryland, College Park

  PRINCIPAL INVESTIGATOR

• Bradley Hennessie, MHA,MBA

  NextStep Robotics Inc.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 11, 2019
• First Posted: October 24, 2019
• Study Start: April 1, 2020
• Primary Completion: August 1, 2020
• Study Completion: August 1, 2020
• Last Updated: September 11, 2020

Record last verified: 2020-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, 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.

Locations

US (1)