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Robotics

Robot-Assisted Physical Therapy for Foot Drop After Stroke

N/A
Recruiting
Research Sponsored by NextStep Robotics Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
In the subacute phase of stroke recovery (>6 weeks to <6 months post-stroke) with residual hemiparesis of the lower extremity that includes symptoms of foot-drop, or in the chronic phase of stroke recovery (>6 months post-stroke) with residual hemiparesis of the lower extremity that includes symptoms of foot-drop
Ages 18 and older
Timeline
Screening 3 weeks
Treatment Varies
Follow Up change from baseline at both 9 weeks and at 21 weeks
Awards & highlights

Study Summary

This trial is testing whether 9 weeks of robot-assisted physical therapy is more effective than physical therapy alone in treating foot drop, as measured by gait biomechanics and clinician assessment.

Who is the study for?
This trial is for adults over 18 who have had a stroke and are experiencing foot drop due to weakness or paralysis on one side of their body. They must be in the subacute phase (6 weeks to 6 months post-stroke) or chronic phase (over 6 months post-stroke). People with other conditions affecting walking, severe hypertension, recent serious illness, significant heart issues, or cognitive impairments that prevent following instructions cannot participate.Check my eligibility
What is being tested?
The study compares robot-assisted physical therapy (PTR) with standard physical therapy alone for treating foot drop after a stroke. Over nine weeks and eighteen sessions, it measures improvements in gait biomechanics and muscle strength through both observation and clinician assessments.See study design
What are the potential side effects?
While specific side effects are not listed for this type of rehabilitation therapy, participants may experience general discomforts such as fatigue or soreness from the exercises. There's also a potential risk of falls during gait training activities.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am in the recovery phase of a stroke, with weakness in my leg causing foot-drop.
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I am 18 years old or older.
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I have a noticeable limp due to weakness on one side.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~change from baseline at both 9 weeks and at 21 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and change from baseline at both 9 weeks and at 21 weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Angle at Initial Contact
Gait Velocity
Number of Heel-First Foot Strikes
+1 more
Secondary outcome measures
Active range of motion for Dorsiflexion
Activities-Specific Balance Confidence Scale
Ankle Muscle Strength
+9 more

Trial Design

4Treatment groups
Experimental Treatment
Active Control
Group I: X-PTR, Cross over group for Physical Therapy n Sub-Acute group.Experimental Treatment1 Intervention
Participants enrolled in the physical therapy only group will be given the option to re-enroll as a cross over participant to receive 18 one-hour PT training sessions over 9 weeks while wearing the robot initially parameterized to individual deficit severity. Subjects perform over-ground mobility tasks of increasing challenge with robotic assist, as needed. Training is generally divided into 3 phases based on individual ability to address gait deficits, postural transitions, physical demand and environmental terrain.
Group II: PTR (Physical Therapy while wearing Robot group) (Phase II)Experimental Treatment1 Intervention
Subjects receive 18 one-hour PT training sessions over 9 weeks while wearing the robot initially parameterized to individual deficit severity. Subjects perform over-ground mobility tasks of increasing challenge with robotic assist, as needed. Training is generally divided into 3 phases based on individual ability to address gait deficits, postural transitions, physical demand and environmental terrain.
Group III: C-PTR, Chronic Stroke Subjects to receive robotic gait training therapy.Experimental Treatment1 Intervention
Chronic stroke subjects receive 18 one-hour PT training sessions over 9 weeks while wearing the robot initially parameterized to individual deficit severity. Subjects perform over-ground mobility tasks of increasing challenge with robotic assist, as needed. Training is generally divided into 3 phases based on individual ability to address gait deficits, postural transitions, physical demand and environmental terrain.
Group IV: PT (Physical Therapy Only) (Phase II)Active Control1 Intervention
Subjects receive 18 one-hour PT training sessions over 9 weeks. Subjects perform over-ground mobility tasks of increasing challenge with therapist assist, as needed. Training is generally divided into 3 phases based on individual ability to address gait deficits, postural transitions, physical demand and environmental terrain.

Find a Location

Who is running the clinical trial?

NextStep Robotics Inc.Lead Sponsor
1 Previous Clinical Trials
1 Trials studying Foot Drop
Brad Hennessie, MHA, MBAStudy DirectorNextStep Robotics Inc.

Media Library

Ankle Robotics (Robotics) Clinical Trial Eligibility Overview. Trial Name: NCT04594837 — N/A
Foot Drop Research Study Groups: X-PTR, Cross over group for Physical Therapy n Sub-Acute group., C-PTR, Chronic Stroke Subjects to receive robotic gait training therapy., PTR (Physical Therapy while wearing Robot group) (Phase II), PT (Physical Therapy Only) (Phase II)
Foot Drop Clinical Trial 2023: Ankle Robotics Highlights & Side Effects. Trial Name: NCT04594837 — N/A
Ankle Robotics (Robotics) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04594837 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What are the primary goals of this research project?

"The primary assessment period for this experiment will be 9 and 21 weeks from the starting baseline. Clinicians are primarily evaluating Angle at Initial Contact, though they have also established a range of secondary measurements including Activities-Specific Balance Confidence Scale (ASBCS), Stroke Impact Scale (SIS), and Number of Participants Using Assistive Devices and Ankle Foot Orthoses (NPAFO)."

Answered by AI

Are particpants being recruited for this experiment at the present time?

"Affirmative. Clinicaltrials.gov's record demonstrates that participation in this medical experiment is currently being sought after, with the first post dating to April 21st 2022 and last update on May 14th 2022. The study requires 140 people from a single site."

Answered by AI

What is the intake capacity for participants in this research?

"Affirmative. Records on clinicaltrials.gov confirm that this medical investigation is currently looking for suitable volunteers; the experiment was initially posted April 21st 2022 and recently updated May 14th of the same year. In total, 140 individuals are needed from one centre to participate in the study."

Answered by AI

Who else is applying?

What state do they live in?
Ohio
How old are they?
18 - 65
What site did they apply to?
University of Maryland Rehabilitation & Orthopaedic Institute
What portion of applicants met pre-screening criteria?
Met criteria

How responsive is this trial?

Typically responds via
Phone Call
Email
Most responsive sites:
  1. University of Maryland Rehabilitation & Orthopaedic Institute: < 24 hours
Average response time
  • < 1 Day
~29 spots leftby Feb 2025