Robot-Assisted Physical Therapy for Foot Drop After Stroke

Overseen By Josh Rudnicki

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: NextStep Robotics Inc.

Disqualifiers: Unstable angina, Recent myocardial infarction, Congestive heart failure, Hypertension, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 3 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

140 Participants Needed

Trial Summary

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 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. ^{1 2 3 4 5}

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. ^{1 2 6 7 8}

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. ^{1 2 3 8 9}

Research Team

Brad Hennessie, MHA, MBA

Principal Investigator

NextStep Robotics Inc.

Eligibility Criteria

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

I am in the recovery phase of a stroke, with weakness in my leg causing foot-drop.

I am 18 years old or older.

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

Exclusion Criteria

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

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

You have trouble speaking or understanding and following simple instructions.

Treatment Details

Interventions

• Ankle Robotics

Trial Overview 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.

Participant Groups

Group I: X-PTR, Cross over group for Physical Therapy n Sub-Acute group. Experimental Treatment 1 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 Treatment 1 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 Treatment 1 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 Control 1 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.

Ankle Robotics is already approved in United States, European Union, China for the following indications:

Approved in United States as Ankle Robotics for:

• Stroke rehabilitation
• Foot drop

Approved in European Union as Ankle Exoskeleton for:

• Post-stroke gait rehabilitation
• Ankle dysfunction

Approved in China as Anklebot for:

• Stroke survivors with foot drop
• Gait training

Who Is Running the Clinical Trial?

NextStep Robotics Inc.

Lead Sponsor

Trials

2

Recruited

140+

Findings from Research

In a study involving sub-acute stroke survivors, integrating robot-assisted gait training with conventional training significantly improved gait recovery, with the swing-controlled ankle robot (SCAR) leading to a higher percentage of independent walkers (56%) compared to conventional training alone (29%).

The power-assisted ankle robot (PAAR) was found to enhance walking speed more effectively than SCAR, indicating that active powered assistance can help users walk faster and more efficiently with their affected leg during rehabilitation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of wearable ankle robotics for stair and over-ground training on sub-acute stroke: a randomized controlled trial. Yeung, LF., Lau, CCY., Lai, CWK., et al.[2021]

A single session of training with an impedance-controlled ankle robot (anklebot) significantly improved motor control in the paretic ankle of chronic stroke patients, showing increased targeting accuracy, higher angular speeds, and smoother movements after just one hour of training.

The improvements in motor control metrics were maintained 48 hours after training, suggesting that the anklebot may facilitate short-term motor learning and adaptation in stroke rehabilitation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Short-term ankle motor performance with ankle robotics training in chronic hemiparetic stroke. Roy, A., Forrester, LW., Macko, RF.[2019]

A study involving 18 stroke survivors with severe hemiplegia demonstrated that early in-bed rehabilitation using a wearable ankle robot significantly improved motor function, strength, and range of motion compared to a control group receiving standard passive movement.

The robot-guided training, which included real-time feedback and active movement exercises, led to earlier recovery of ankle movements, highlighting its potential as an effective intervention for enhancing rehabilitation outcomes in acute stroke patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Intensive In-Bed Sensorimotor Rehabilitation of Early Subacute Stroke Survivors With Severe Hemiplegia Using a Wearable Robot. Zhang, C., Huang, MZ., Kehs, GJ., et al.[2023]

Wearable robotic exoskeletons (REs) significantly improve gait and balance in adults with acquired brain injury (ABI), enhancing parameters like step length, walking speed, and spatial symmetry.

The study indicates that high-dose, repetitive gait training with REs can effectively promote functional recovery in individuals with ABI, as evidenced by improved center of pressure displacement and reduced gait cycle time.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Changes in Center of Pressure after Robotic Exoskeleton Gait Training in Adults with Acquired Brain Injury. Karunakaran, KK., Pamula, S., Nolan, KJ.[2021]

Powered robotic exoskeletons are a safe intervention for gait rehabilitation in stroke patients, showing meaningful improvements in walking outcomes, especially in those who are in the sub-acute phase of recovery.

While exoskeleton training is equivalent to traditional therapy for chronic stroke patients, sub-acute patients may benefit more from this technology, indicating a need for further rigorous trials to establish its clinical effectiveness.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Powered robotic exoskeletons in post-stroke rehabilitation of gait: a scoping review. Louie, DR., Eng, JJ.[2023]

Wearable ankle robots show promise in improving gait rehabilitation for stroke survivors, with 97 participants demonstrating enhanced peak dorsiflexion, propulsion on the affected side, and increased walking speed after training.

The study highlights the effectiveness of mixed sensing technology in detecting motion intention, but emphasizes the need for more comparative trials and multicenter randomized controlled trials to further validate the clinical benefits of these devices.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Wearable Ankle Robots in Post-stroke Rehabilitation of Gait: A Systematic Review. Shi, B., Chen, X., Yue, Z., et al.[2020]

In a 6-week study involving 8 participants with chronic stroke, robot-assisted ankle training significantly reduced passive ankle stiffness (PAS) in both dorsiflexion and plantar flexion, bringing it in line with age-matched controls.

The reduction in plantar flexion PAS was strongly correlated with improvements in paretic step and stride lengths during walking, indicating that this training method positively impacts gait function in stroke survivors.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Changes in passive ankle stiffness and its effects on gait function in people with chronic stroke. Roy, A., Forrester, LW., Macko, RF., et al.[2019]

A wearable ankle robotic device was tested on 10 acute stroke survivors over 12 sessions, showing that early in-bed rehabilitation can enhance motor control and promote neuroplasticity.

The device offers both passive stretching and active movement training, using real-time feedback to guide patients, which is crucial for effective motor recovery shortly after a stroke.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Developing a Wearable Ankle Rehabilitation Robotic Device for in-Bed Acute Stroke Rehabilitation. Ren, Y., Wu, YN., Yang, CY., et al.[2019]

In a study of 24 stroke survivors, those who underwent 6 weeks of training with a portable rehabilitation robot showed significantly greater improvements in spasticity, mobility, balance, and strength compared to those who followed a home exercise program.

Both groups experienced some improvements in mobility and strength, but the robot-assisted training was more effective in enhancing overall motor function and mobility after stroke.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of robot-guided passive stretching and active movement training of ankle and mobility impairments in stroke. Waldman, G., Yang, CY., Ren, Y., et al.[2016]

References

1. England pubmed.ncbi.nlm.nih.gov

Effects of wearable ankle robotics for stair and over-ground training on sub-acute stroke: a randomized controlled trial. [2021]

2. United States pubmed.ncbi.nlm.nih.gov

Short-term ankle motor performance with ankle robotics training in chronic hemiparetic stroke. [2019]

3. United States pubmed.ncbi.nlm.nih.gov

Intensive In-Bed Sensorimotor Rehabilitation of Early Subacute Stroke Survivors With Severe Hemiplegia Using a Wearable Robot. [2023]

4. United States pubmed.ncbi.nlm.nih.gov

Changes in Center of Pressure after Robotic Exoskeleton Gait Training in Adults with Acquired Brain Injury. [2021]

5. England pubmed.ncbi.nlm.nih.gov

Powered robotic exoskeletons in post-stroke rehabilitation of gait: a scoping review. [2023]

6. Switzerland pubmed.ncbi.nlm.nih.gov

Wearable Ankle Robots in Post-stroke Rehabilitation of Gait: A Systematic Review. [2020]

7. United States pubmed.ncbi.nlm.nih.gov

Changes in passive ankle stiffness and its effects on gait function in people with chronic stroke. [2019]

8. United States pubmed.ncbi.nlm.nih.gov

Developing a Wearable Ankle Rehabilitation Robotic Device for in-Bed Acute Stroke Rehabilitation. [2019]

9. Netherlands pubmed.ncbi.nlm.nih.gov

Effects of robot-guided passive stretching and active movement training of ankle and mobility impairments in stroke. [2016]