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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

Ages 18 and older

Clear indications of hemiparetic gait by clinical observation

Must not have

Medical History: recent hospitalization (less than 3 months) for severe medical disease, symptomatic peripheral arterial occlusive disease, orthopedic or chronic pain conditions that significantly alter gait function, pulmonary or renal failure, or active cancer

Hypertension that is a contraindication for routine physical therapy (greater than 160/100 on two assessments)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up change from baseline at both 9 weeks and at 21 weeks

Awards & highlights

No Placebo-Only Group

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.

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.

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 18 years old or older.

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I have a noticeable limp due to weakness on one side.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have not been hospitalized for a severe condition in the last 3 months.

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My blood pressure is too high for physical therapy (over 160/100 twice).

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I have a muscle or nerve condition that affects my ability to walk.

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I have had recent serious heart issues or heart failure.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ change from baseline at both 9 weeks and at 21 weeks

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Angle at Initial Contact

Gait Velocity

Number of Heel-First Foot Strikes

+1 more

Secondary study objectives

Active range of motion for Dorsiflexion

Activities-Specific Balance Confidence Scale

Ankle Muscle Strength

+9 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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.

0 / 6Eligibility criteria met