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Robotics

Seated Ankle Robot Training for Foot Drop

N/A
Waitlist Available
Led By Charlene E. Hafer-Macko, M.D.
Research Sponsored by Baltimore VA Medical Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Chronic foot drop and ankle weakness in one leg from a peripheral nervous system injury due to a neuromuscular or orthopedic injury
Be older than 18 years old
Must not have
Active deep venous thrombosis
Distal paretic leg skin lesions, infections, or soft tissue inflammation
Timeline
Screening 3 weeks
Treatment Varies
Follow Up change from baseline to: post-6 weeks of training, and 6 weeks after completion of training
Awards & highlights
No Placebo-Only Group

Summary

This trial will test if an ankle robot can help people with ankle weakness and foot drop from a peripheral nervous system injury.

Who is the study for?
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.
What is being tested?
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.
What are the potential side effects?
While not explicitly listed, potential side effects may include discomfort at the site of robotic assistance, muscle soreness, fatigue from exercise, or skin irritation around the affected area.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I have chronic foot drop and ankle weakness in one leg due to a nerve or muscle injury.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
I currently have a deep vein blood clot.
Select...
I have skin issues or infections on my weak leg.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~change from baseline to: post-6 weeks of training, and 6 weeks after completion of training
This trial's timeline: 3 weeks for screening, Varies for treatment, and change from baseline to: post-6 weeks of training, and 6 weeks after completion of training for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Ankle
Ankle inversion-eversion range of motion
Gait
+3 more

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups
Experimental Treatment
Group I: Seated Ankle Robot TrainingExperimental Treatment1 Intervention

Find a Location

Who is running the clinical trial?

Baltimore VA Medical CenterLead Sponsor
32 Previous Clinical Trials
2,995 Total Patients Enrolled
Charlene E. Hafer-Macko, M.D.Principal InvestigatorBaltimore VA Medical Center
1 Previous Clinical Trials
100 Total Patients Enrolled

Media Library

Seated Ankle Robot (Robotics) Clinical Trial Eligibility Overview. Trial Name: NCT03530592 — N/A
Peripheral Neuropathy Research Study Groups: Seated Ankle Robot Training
Peripheral Neuropathy Clinical Trial 2023: Seated Ankle Robot Highlights & Side Effects. Trial Name: NCT03530592 — N/A
Seated Ankle Robot (Robotics) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03530592 — N/A
~39 spots leftby Dec 2028