Robot-Assisted Physical Therapy for Foot Drop After Stroke
What You Need to Know Before You Apply
What is the purpose of this trial?
The randomized study (in Phase II of the U44) compares the efficacy and durability of 9 weeks (18 sessions) of robot-assisted physical therapy (PTR) versus physical therapy (PT) alone on foot drop as assessed by gait biomechanics (ankle angle at initial contact, peak swing ankle angle, number of heel-first strikes - % total steps, gait velocity) and blinded clinician assessment (dorsiflexion active range of motion, ankle muscle strength, assistive device needs).
Do I need to stop my current medications for the trial?
The trial protocol does not specify whether you need to stop taking your current medications.
What safety data exists for robot-assisted physical therapy for foot drop after stroke?
The studies reviewed indicate that wearable ankle robots, including devices like the 'anklebot,' have been used in various trials for stroke rehabilitation. These devices have shown potential benefits in improving gait and motor control in stroke survivors. The trials have generally reported improvements in motor performance, gait function, and ankle stiffness without significant safety concerns. However, the need for larger, multicenter randomized controlled trials is noted to further validate these findings and ensure comprehensive safety data.12345
Is Ankle Robotics a promising treatment for foot drop after stroke?
Yes, Ankle Robotics is a promising treatment for foot drop after stroke. It helps improve walking ability by providing support and assistance to the ankle, which can lead to better motor control and faster recovery. Studies show that it can enhance gait recovery, improve motor performance, and promote independence in stroke patients.12567
What data supports the idea that Robot-Assisted Physical Therapy for Foot Drop After Stroke is an effective treatment?
The available research shows that Robot-Assisted Physical Therapy, like using ankle robotics, can improve walking ability in stroke patients. One study found that combining traditional therapy with robot-assisted training helped early stroke patients walk better and become more independent. Another study showed that even a single session of training with an 'anklebot' improved ankle control in stroke patients, with benefits lasting at least 48 hours. Additionally, using wearable robots for in-bed training led to better strength and movement in stroke patients compared to those who didn't use the robots. Overall, these studies suggest that robot-assisted therapy can be more effective than traditional methods alone, especially in the early stages after a stroke.12689
Who Is on the Research Team?
Brad Hennessie, MHA, MBA
Principal Investigator
NextStep Robotics Inc.
Are You a Good Fit for This Trial?
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.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive 18 sessions of robot-assisted physical therapy (PTR) or physical therapy (PT) alone over 9 weeks to improve foot drop outcomes.
Follow-up
Participants are monitored for safety and effectiveness after treatment, with assessments at 9 and 21 weeks.
What Are the Treatments Tested in This Trial?
Interventions
- Ankle Robotics
Ankle Robotics is already approved in United States, European Union, China for the following indications:
- Stroke rehabilitation
- Foot drop
- Post-stroke gait rehabilitation
- Ankle dysfunction
- Stroke survivors with foot drop
- Gait training
Find a Clinic Near You
Who Is Running the Clinical Trial?
NextStep Robotics Inc.
Lead Sponsor