Exoskeleton Controller for Stroke

Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: University of Michigan
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a new robotic leg device that uses smart software to improve walking, particularly for stroke survivors. The research tests whether this "smart" software, called the Unified Control Framework for Lower-Limb Powered Orthosis, can predict and adapt to individual walking needs, unlike standard devices that offer fixed support. Participants will walk on treadmills and various surfaces while wearing the robotic leg to assess improvements in walking speed and mobility. Healthy adults and stroke survivors who have difficulty walking and can participate in physical exercise may be suitable for this trial. As an unphased trial, it offers participants the chance to contribute to innovative research that could enhance mobility solutions for stroke survivors.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that this new control software framework is safe for use in stroke rehabilitation?

Research has shown that robotic therapy, such as the new software under testing, is generally safe and well-tolerated. Although detailed safety information about this specific software is still limited, similar robotic devices have been used safely in rehabilitation. Studies have found that robot-assisted therapy using traditional robotic controllers is both safe and effective. Most studies report no serious side effects, though some participants have experienced minor issues like discomfort or mild pain. Overall, these robotic controllers are considered safe, with few side effects reported.12345

Why are researchers excited about this trial?

Researchers are excited about the new "unified control framework" for stroke rehabilitation because it introduces a smart, adaptive robotic exoskeleton that adjusts to the user's needs in real-time. Unlike conventional robotic controllers, which follow a fixed pattern, this innovative framework uses advanced algorithms to tailor its support dynamically, potentially leading to better outcomes in mobility and independence for stroke survivors. This personalized approach could revolutionize rehabilitation by offering more effective and efficient recovery compared to current robotic systems.

What evidence suggests that this trial's treatments could be effective for stroke recovery?

This trial will compare two different exoskeleton controllers for stroke recovery. Research has shown that the new "unified control framework," used by participants in the experimental arm, could improve walking after a stroke. Studies have found that systems adjusting to a person's unique gait can lead to better outcomes than static systems. This smart control software quickly understands user needs and adapts immediately, potentially enhancing walking speed and overall movement. Evidence suggests this flexible approach could lead to more improvement than the conventional controller used in the active comparator arm. Overall, these early findings offer hope for better stroke recovery.678910

Are You a Good Fit for This Trial?

This trial is for adults who have had a stroke and are experiencing walking difficulties, as well as healthy adults. Participants should be able to walk with or without help and must not have other serious health issues that would prevent safe participation.

Inclusion Criteria

Cohort 2: Stable medical condition allowing for participation in intensive physical rehabilitation tasks
Cohort 2: Able to provide informed consent
I am a healthy young adult with no issues affecting my walking or balance.
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Exclusion Criteria

Any medical contraindication to intensive walking exercise or treadmill training (e.g., unstable angina, severe unmanaged cardiovascular disease)
I have a neurological condition, other than stroke, that affects my movement.
I do not have any open wounds or severe unhealed skin lesions where the device touches my body.
See 2 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment Phase 1

Participants train with the new 'unified control framework' (smart, adaptive robotic exoskeleton) and the 'conventional controller' (standard robotic exoskeleton controller) over a 4-week period.

4 weeks
12 training sessions

Washout Period

A period between interventions to minimize carryover effects from the first treatment phase.

4 weeks

Treatment Phase 2

Participants continue training with the alternate control framework for another 4-week period.

4 weeks
12 training sessions

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • Conventional Robotic Controller
  • Unified Control Framework for Lower-Limb Powered Orthosis

Trial Overview

The study compares two types of robotic leg controllers: a new smart system that adapts to each person's walking needs using sensors and machine learning, versus a standard controller with fixed assistance. Both are tested during treadmill or walkway training sessions.

How Is the Trial Designed?

2

Treatment groups

Experimental Treatment

Active Control

Group I: Experimental ArmExperimental Treatment1 Intervention
Group II: Active Comparator ArmActive Control1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

University of Michigan

Lead Sponsor

Trials
1,891
Recruited
6,458,000+

Citations

This Study Evaluates the Use of a Data-driven Lower Limb ...

This metric evaluates the preliminary clinical efficacy of the unified control framework compared to the conventional controller in chronic ...

Control strategies used in lower limb exoskeletons for gait ...

Trajectory-tracking control is the most used Mid-level control strategy in lower limb exoskeletons for rehabilitation (97.7%). The most common approach is to ...

This Study Evaluates the Use of a Data-driven Lower Limb ...

The goal of this clinical trial is to test a new, impairment-aware robotic control software framework to see if its smart adaptation can ...

Outcome measures and motion capture systems for ...

There is evidence for assessing the evidence of orthosis-based gait rehabilitation after stroke through activity outcome measures, primarily the gait speed, ...

Recent development of mechanisms and control strategies ...

This paper gives a review and analysis of mechanisms, training modes and control strategies of lower limb rehabilitation robots, especially the control methods ...

COMPARATIVE EFFECTIVENESS OF ROBOT-ASSISTED ...

The aim of this study was to compare the efficacy of robot-assisted training and therapist-mediated enhanced upper extremity therapy on the upper and lower ...

Is the Rehabilitation Robotic a Safe and Effective Choice ...

Some results are very promising, showing that robot-assisted therapy is safe and well tolerated and that it has a positive impact on muscle strength and ...

Upper limb robotic rehabilitation following stroke: a systematic ...

However, additional sessions of robotic rehabilitation yielded better motor control outcomes compared with conventional rehabilitation alone ...

Effects of Robot-Assisted Therapy for Upper Limb ...

Most studies did not mention any adverse effects, with a small number of reports on discomfort, shoulder pain, and finger blisters.

Efficacy of Robot-assisted Training on Upper Limb Motor ...

The current evidence showed that RAT combined with routine rehabilitation therapy can effectively improve the upper limb motor function and activities of daily ...