Dorsiflexion Specific Ankle Robotics to Enhance Motor Learning After Stroke: A Preliminary Report.
Anindo Roy, Bradley Hennessie, Charlene Hafer-Macko...
https://pubmed.ncbi.nlm.nih.gov/38978605/Actively 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
J
Josh Rudnicki
R
Richard Macko, MD
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NextStep Robotics Inc.
Lead Sponsor
This table compares participation in this trial with other options available for this condition. The information is drawn from published research and the trial’s study details and is provided for educational purposes only.
| Factors | PTR (robot‑assisted physical therapy) | PT only (no robotic assist) | Standard care (AFO or FES) |
|---|---|---|---|
| What it is | Over‑ground mobility training while wearing an ankle robotic device tailored to individual gait deficits | Over‑ground mobility training using physical therapy only, without robotic assistance | Use of ankle‑foot orthosis or functional electrical stimulation to manage foot‑drop in stroke survivors |
| Role in the trial | Experimental arm combining PT with robotic ankle assistance | Active comparator arm delivering PT without robotic device | Not part of this study but represents commonly used current‑care options |
| Purpose or intended use | Improve gait biomechanics and motor control in individuals with post‑stroke foot‑drop | Improve motor control and walking performance through PT exercises | Assist toe clearance and support gait speed and balance in stroke survivors with foot‑drop |
| How it is given or performed | 18 one‑hour over‑ground PT sessions over 9 weeks wearing a customized ankle robot | 18 one‑hour over‑ground PT sessions over 9 weeks without robotic assistance | Daily gait support using an external AFO or scheduled FES during walking activities |
| Important risks | Not yet established for the investigational robotic device | General risks limited to physical therapy, such as fatigue or muscle soreness | Potential discomfort or skin irritation from AFO; mild muscle fatigue or stimulation discomfort with FES |
| Important limitations | Effectiveness and durability of improvements beyond 21 weeks are unknown | Therapy without robotic assist may not address neuromotor impairments as intensively as technology‑augmented approaches | AFO and FES assist gait but do not directly train ankle motor control or promote lasting neuroplastic change |
Disclaimer: This comparison is created with the help of artificial intelligence(AI) and may contain errors or missing information. It is not medical advice and does not mean one option is better or safer than another. Clinical trials are still being studied, and joining a trial is your choice. Please consult your healthcare professional before making any decisions.
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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)
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/38978605/Anindo Roy, Bradley Hennessie, Charlene Hafer-Macko...
https://pubmed.ncbi.nlm.nih.gov/41462280/NextStep Robotics Inc.
Lead Sponsor