Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
ID04594837

Portable Ankle Robotics to Reverse Foot Drop After Stroke

Led by NextStep Robotics Inc. · Updated on 2023-01-26

140

Participants Needed

1

Research Sites

N/A

Total Duration

On this page

AI-Summary

What this Trial Is About

Researchers are evaluating the effects of a portable ankle robot (AMBLE) used in physical therapy to reduce foot drop and improve walking in stroke survivors with hemiparesis. The study focuses on people who are in the subacute phase (6 weeks to 6 months) or chronic phase (more than 6 months) after stroke and experience difficulty lifting the foot during walking. This study compares robot-assisted physical therapy with conventional physical therapy to see which better improves walking biomechanics and clinical assessments of foot drop. Participants receive 18 one-hour physical therapy sessions over 9 weeks. One group uses the AMBLE robot during therapy to assist foot lifting as needed while performing walking tasks, with training progressing through three phases based on individual ability. The other group receives standard physical therapy without the robot. Those initially in the physical therapy only group may choose to crossover to receive robot-assisted therapy. The study includes both subacute and chronic stroke patients, with therapy tailored to address gait, posture, physical demand, and environmental challenges. During the study, participants will have their walking assessed through biomechanical measures like ankle angles and gait speed, as well as clinical evaluations of muscle strength, range of motion, and use of assistive devices. Assessments occur at baseline, after 9 weeks of therapy, and again at 21 weeks to evaluate lasting effects. Researchers will also monitor balance, fatigue, depression, and stroke impact via various scales. The total participation lasts several months, allowing for measurement of both immediate and longer-term changes in walking function and safety.

CONDITIONS

Brief Title

Ankle Robotics After Stroke

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Ages 18 and older
  • In subacute phase of stroke recovery (over 6 weeks to less than 6 months) with residual hemiparesis including foot drop
  • Or in chronic phase of stroke recovery (more than 6 months) with residual hemiparesis including foot drop
  • Clear signs of hemiparetic gait by clinical observation
Not Eligible

You will not qualify if you...

  • Unstable angina or recent (less than 3 months) heart attack or congestive heart failure (NYHA category II)
  • Significant heart valve problems
  • High blood pressure above 160/100 on two assessments
  • Recent hospitalization (less than 3 months) for severe medical illness
  • Symptomatic peripheral arterial disease
  • Orthopedic or chronic pain issues that significantly affect walking
  • Lung or kidney failure
  • Active cancer
  • Non-stroke neuromuscular disorders affecting walking
  • Aphasia or cognitive problems preventing following two-step commands or judged unable to participate by medical staff

AI-Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Treatment

Duration - 9 weeks

Participants receive 18 one-hour physical therapy training sessions over 9 weeks. Those in the experimental groups wear a portable ankle robot during sessions to assist with foot lifting during walking, while others receive usual physical therapy without the robot. Training involves progressively challenging over-ground mobility tasks tailored to individual ability.

18 visits (in-person, approximately 2 per week)

Follow-up

Duration - Up to 12 weeks

Participants are assessed to measure improvements in foot drop and walking function after completing therapy. Outcome assessments occur up to 12 weeks after treatment ends to evaluate longer-term effects.

1 to 2 visits (in-person)

Trial Site Locations

Total: 1 location

1

University of Maryland Rehabilitation & Orthopaedic Institute

Baltimore, Maryland, United States, 21207

Actively Recruiting

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Research Team

J

Josh Rudnicki

R

Richard Macko, MD

How is the study designed?

Study Type

INTERVENTIONAL

Masking

SINGLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

4

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Published Research Related To This Trial

Adaptive control ankle robotics training durably improves gait biomechanics in chronic hemiparetic stroke and footdrop.

Anindo Roy, Bradley Hennessie, Charlene Hafer-Macko...

https://pubmed.ncbi.nlm.nih.gov/41462280