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

100 Participants Needed

Trial Summary

What is the purpose of this trial?

The purpose of this research study is to test the utility of an ankle robot in people with ankle weakness and foot drop from a peripheral nervous system injury due to neuromuscular or orthopedic injury.

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 data supports the effectiveness of the treatment Seated Ankle Robot for foot drop?

Research on robotic ankle-foot orthoses, which are similar to the Seated Ankle Robot, shows they can help improve foot position and walking ability in people with foot drop. One study found that a robotic device helped a patient achieve better foot positioning during walking, suggesting potential benefits for similar robotic treatments. ^{1 2 3 4 5}

Is the Seated Ankle Robot generally safe for humans?

The Seated Ankle Robot, evaluated under different names, includes safety measures in its design to protect users during rehabilitation. Research on similar ankle rehabilitation robots highlights the importance of stability and safety features, suggesting that these devices are generally safe for human use. ^{4 6 7 8 9}

How does the Seated Ankle Robot treatment for foot drop differ from other treatments?

The Seated Ankle Robot treatment is unique because it uses a robotic device to provide active training strategies, allowing for complex and specialized movements that improve ankle strength and control. Unlike traditional therapies, this approach offers a high level of adaptability to the mechanical properties of the human ankle, potentially enhancing rehabilitation outcomes. ^{4 7 10 11 12}

Research Team

Charlene E. Hafer-Macko, M.D.

Principal Investigator

Baltimore VA Medical Center

Eligibility Criteria

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 am between 18 and 88 years old.

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

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

Treatment Details

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.

Participant Groups

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+

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]

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]

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]

References

1. Switzerland pubmed.ncbi.nlm.nih.gov

Immediate Effect Evaluation of a Robotic Ankle-Foot Orthosis with Customized Algorithm for a Foot Drop Patient: A Quantitative and Qualitative Case Report. [2023]

2. England pubmed.ncbi.nlm.nih.gov

Walking while resisting a perturbation: Effects on ankle dorsiflexor activation during swing and potential for rehabilitation. [2013]

3. Sweden pubmed.ncbi.nlm.nih.gov

Comparison of walking energy cost between an anterior and a posterior ankle-foot orthosis in people with foot drop. [2018]

4. England pubmed.ncbi.nlm.nih.gov

Reviewing Clinical Effectiveness of Active Training Strategies of Platform-Based Ankle Rehabilitation Robots. [2019]

5. Netherlands pubmed.ncbi.nlm.nih.gov

Reliability of IMU-Derived Gait Parameters in Foot Drop Patients. [2023]

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

New Neuromuscular Training for Peripheral Nerve Disorders Using an Ankle Joint Hybrid Assistive Limb: A Case Series. [2023]

7. 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]

8. England pubmed.ncbi.nlm.nih.gov

A review on the mechanical design elements of ankle rehabilitation robot. [2015]

9. England pubmed.ncbi.nlm.nih.gov

Effect of kinesiotaping, non-elastic taping and bracing on segmental foot kinematics during drop landing in healthy subjects and subjects with chronic ankle instability. [2017]

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

Design of a robotic gait trainer using spring over muscle actuators for ankle stroke rehabilitation. [2019]

11. England pubmed.ncbi.nlm.nih.gov

Robot-assisted ankle rehabilitation: a review. [2021]

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

Position versus force control: using the 2-DOF robotic ankle trainer to assess ankle's motor control. [2020]