TREAT Foot Drop After Stroke With Ankle Robot
Trial Snapshot
- Phase
- Not Applicable
- Status
- Withdrawn
- Sponsor
- NextStep Robotics Inc.
- Locations
- 1
- Primary Endpoint
- Donning/Doffing Time
Study Overview
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.
Detailed Description
This study is designed to see if the ankle robot is safe and effective to use in restoring gait function in individuals with foot drop.
This research project will be conducted at the University of Maryland Rehabilitation and Orthopaedic Institute (UM Rehab). There will be approximately 10 individuals from the Baltimore, Maryland area recruited to voluntarily participate in this study.
If you take part in this research, you will be asked:
- To participate in this study for approximately 10 weeks total.
- Attend at least 6 ankle robot gait training sessions that will last 45-60 minutes each session, 3 times a week for 2 weeks at UM Rehab.
- Undergo a medical and neurological evaluation at screening.
- Perform balance and walking tests with and without your usual assistive walking device.
- Walk on a treadmill with the ankle robot on your foot.
- Report to the research team any changes to assistive walking device usage between training sessions, and any health-related issues or changes.
- Maintain your current medications at their current doses and schedules throughout this study, or inform the study physician about any medication changes.
- Not to participate in any other study that would affect our results.
- You will be seated and fitted with the ankle robot before each testing visit and each gait training session. During the fitting process, the ankle robot will be secured to the stroke affected lower leg using a modified shin guard that has Velcro straps. Regular shoes will be worn. The "shoe covered" affected foot will be inserted into a modified slipper. Comfort and fit will be noted. Should you have any discomfort or feeling like the ankle robot device is rubbing on skin, padding will be applied to protect the skin.
- A gait belt will be worn around the waist and research staff will use this belt to provide support, and to protect against falls during the balance/walking tests and during ankle robot gait training sessions.
- Gait training sessions will be conducted with usual assistive devices for balance and with the ankle robot turned on and turned off.
- The research team will periodically collect heart rate and blood pressure measurements to determine how hard you are working during various tasks. You will be asked how you feel while performing these tasks. Researchers will use this information to guide the gait training program.
Tests will be completed at 3 points: baseline (before beginning training), after the 2-week gait training program, and then 6 weeks after the program.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Other
- Masking
- None
Eligibility Criteria
- Ages
- 21 Years to 75 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
Robot Group
1-arm study where eligible volunteers will undergo robotic testing for safety, comfort, and fit.
Intervention: AMBLE (Device)
Outcomes
Primary Outcomes
Donning/Doffing Time
Time Frame: Baseline
Average time (minutes) for donning/doffing the device per subject over the course of intervention.
6-minute Walk Test
Time Frame: Change from Baseline at both 2 Weeks and at 8 Weeks
Assesses distance (meters) walked over 6 minutes.
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.
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.
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.
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 Outcomes
- Swing Dorsiflexion(Change from Baseline at both 2 Weeks and at 8 Weeks)
- 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)
- Number of Heel-First Foot Strikes(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 Participants Using Assistive Devices and Ankle Foot Orthoses(Change from Baseline at both 2 Weeks and at 8 Weeks)