Seated Ankle Robot Training for Foot Drop

Overseen By Kate C. Flores

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Baltimore VA Medical Center

Disqualifiers: Orthopedic programs, DVT, skin lesions, others

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

Compensation: Varies

Number of Visits: Unknown

Duration: 6 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new seated ankle robot designed to assist individuals with foot drop and ankle weakness, often resulting from nerve or muscle injuries. The goal is to determine if the robot can enhance movement and strength in the affected foot. Individuals with long-term foot drop who can walk 10 meters using a walking aid may be suitable candidates. The study aims to ease daily activities for those facing these injuries. As an unphased trial, it offers a unique opportunity to contribute to innovative research that could improve daily life for individuals with similar conditions.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

What prior data suggests that this ankle robot is safe for people with foot drop?

Research has shown that the seated ankle robot has been used safely in past studies. In earlier research on foot drop caused by stroke, the ankle robot showed promise without causing any serious side effects. Another study with a similar robotic device for ankle movement found it safe, with no harmful effects reported.

These findings suggest that the seated ankle robot is generally well-tolerated. Although this trial does not test a drug, safety data from similar devices reassures potential participants. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Seated Ankle Robot for foot drop because it offers a unique approach to rehabilitation by using robotic technology to assist with precise ankle movements. Unlike standard treatments like physical therapy and ankle-foot orthoses, this robotic system provides consistent, repeatable exercises that can be fine-tuned to the patient's needs. This method could potentially enhance muscle control and improve walking ability more effectively and quickly than traditional methods.

What evidence suggests that this ankle robot is effective for foot drop?

Research has shown that robot-assisted therapy effectively aids ankle rehabilitation. Studies have found that robotic ankle devices improve movement and strength in people with foot drop, a condition caused by nerve or muscle problems. This trial will specifically evaluate the Seated Ankle Robot, which assists the ankle in moving in specific ways to enhance walking and balance. Early results suggest that using a seated ankle robot benefits those with ankle weakness and foot drop. ^{6 7 8 9 10}

Who Is on the Research Team?

Charlene E. Hafer-Macko, M.D.

Principal Investigator

Baltimore VA Medical Center

Are You a Good Fit for This Trial?

This trial is for men and women aged 18 to 88 with chronic foot drop and ankle weakness in one leg due to neuromuscular or orthopedic injuries. Participants must be able to walk 10 meters and get up from a chair without help, though they can use assistive devices.

Inclusion Criteria

I have chronic foot drop and ankle weakness in one leg due to a nerve or muscle injury.

I can walk 10 meters and get up from a chair by myself, but I may use devices like a cane.

Exclusion Criteria

I have no health issues preventing me from sitting and using a rehabilitation robot.

I currently have a deep vein blood clot.

I have skin issues or infections on my weak leg.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo training with the seated ankle robot for 6 weeks to improve ankle movement and reduce foot drop

6 weeks

Follow-up

Participants are monitored for changes in ankle movement and gait 6 weeks after completion of training

6 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Seated Ankle Robot

Trial Overview The study is testing the effectiveness of a seated ankle robot training program designed for people suffering from foot drop as a result of peripheral nervous system injuries.

How Is the Trial Designed?

Group I: Seated Ankle Robot Training Experimental Treatment 1 Intervention

Who Is Running the Clinical Trial?

Baltimore VA Medical Center

Lead Sponsor

Trials

33

Recruited

3,000+

Published Research Related to This Trial

The virtually interfaced robotic ankle and balance trainer (vi-RABT) is a cost-effective rehabilitation tool designed to enhance ankle strength, mobility, and control, particularly beneficial for individuals with ankle disabilities.

In tests with healthy subjects, the vi-RABT demonstrated that participants had improved control over ankle position compared to force, indicating its potential effectiveness in rehabilitation settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Position versus force control: using the 2-DOF robotic ankle trainer to assess ankle's motor control. Farjadian, AB., Nabian, M., Hartman, A., et al.[2020]

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]

Robotic devices for ankle rehabilitation have shown promise, but only a few designs have been successfully commercialized, indicating a gap between research and practical application.

Current rehabilitation robots primarily support plantarflexion-dorsiflexion movements, but many lack the ability to facilitate adduction-abduction movements, highlighting a need for improved designs that can adapt to various patient needs and conditions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Robot-assisted ankle rehabilitation: a review. Alvarez-Perez, MG., Garcia-Murillo, MA., Cervantes-Sánchez, JJ.[2021]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC3636117/

Effectiveness of robot-assisted therapy on ankle rehabilitation All trials assessing the clinical outcomes of robot-assisted ankle rehabilitation training were included. ... Plantarflexor weakness as a limiting factor of gait ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9057677/

Ankle dorsiflexion training with a newly developed Hybrid ... A new robotic ankle, the Hybrid Assistive Limb, has been developed for the treatment of foot drop caused by common peroneal nerve palsy or sequelae of stroke.

3. journals.sagepub.com journals.sagepub.com/doi/10.3233/NRE-230173?icid=int.sj-abstract.citing-articles.5

Ankle rehabilitation robot training for stroke patients with ... Patients with stroke are unable to dorsiflex or have inadequate dorsiflexion due to triceps spasm and ankle dorsiflexion muscle weakness, resulting in a ...

4. withpower.com withpower.com/trial/phase-peripheral-nervous-system-diseases-5-2018-2cb1d

Seated Ankle Robot Training for Foot Drop What data supports the effectiveness of the treatment Seated Ankle Robot for foot drop? ... I have chronic foot drop and ankle weakness in one leg due to a nerve ...

5. researchgate.net researchgate.net/publication/375157273_Ankle_rehabilitation_robot_training_for_stroke_patients_with_foot_drop_Optimizing_intensity_and_frequency

(PDF) Ankle rehabilitation robot training for stroke patients ... ... dorsiflexion due to triceps spasm. and ankle dorsiflexion muscle weakness, resulting in. a “circling gait” when walking (Fernandez-Gonzalez. et ...

6. clinicaltrials.gov clinicaltrials.gov/study/NCT03530592?cond=%22Peripheral%20Nervous%20System%20Diseases%22&aggFilters=status:not%20rec&rank=4

Seated Ankle Robot for Foot Drop in Aging and Disabled ... Data from the investigators' previous studies on foot drop due to stroke show great promise for this ankle robot as a new rehabilitation tool for invididuals ...

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10789316/

Ankle rehabilitation robot training for stroke patients with ... Foot drop is a common lower extremity sequela of stroke and at least 20% to 30% of post-stroke patients have foot drop (Peishun et al., 2021). Patients with ...

8. jneuroengrehab.biomedcentral.com jneuroengrehab.biomedcentral.com/articles/10.1186/s12984-018-0394-7

Randomized controlled trial of robot-assisted gait training with ... This study aims to investigate the therapeutic effects of robot-assisted gait training with ankle dorsiflexion assistance.

9. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8955947/

Development of a New Ankle Joint Hybrid Assistive Limb Voluntary ankle dorsiflexion training using the novel robotics ankle HAL was safe and had no adverse effect in a patient with foot drop due to ...

10. clinicaltrials.gov clinicaltrials.gov/study/NCT04594837

Study Details | NCT04594837 | Ankle Robotics After Stroke If wearing the AMBLE robot during physical therapy in this time-frame reduces foot drop and improves longer term outcomes measured 3 months after all robotics ...