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/41462280Actively Recruiting
Led by NextStep Robotics Inc. · Updated on 2023-01-26
140
Participants Needed
1
Research Sites
N/A
Total Duration
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
Ankle Robotics After Stroke
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Complete this quick 3-step screening to check your eligibility
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
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)
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)
Total: 1 location
1
University of Maryland Rehabilitation & Orthopaedic Institute
Baltimore, Maryland, United States, 21207
Actively Recruiting
J
Josh Rudnicki
R
Richard Macko, MD
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
4
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Anindo Roy, Bradley Hennessie, Charlene Hafer-Macko...
https://pubmed.ncbi.nlm.nih.gov/41462280Anindo Roy, Bradley Hennessie, Charlene Hafer-Macko...
https://pubmed.ncbi.nlm.nih.gov/38978605