NCT07616167
This Study Evaluates the Use of a Data-driven Lower Limb Exoskeleton Controller for Stroke Rehabilitation.
Not Yet Recruiting
NAAges 18–80InterventionalTreatmentUniversity of MichiganInvestigator-initiated
~20 participants
Updated 2026-06-01 on ClinicalTrials.gov
What's tested:Unified Control Framework for Lower-Limb Powered OrthosisConventional Robotic Controller
At a glance
Recruiting sites
0 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Walking Speed
Measured over Baseline (Week 0), Post-Intervention Phase 1 (Week 4), Post-Washout / Pre-Intervention Phase 2 (Week 8), and Post-Intervention Phase 2 (Week 12).
+1 more outcome measured
Conditions
Where it's being run
1 sites across 1 statesMichigan1
Who to contact
This trial hasn't published a contact. View it on ClinicalTrials.gov
Do you actually qualify for this trial?
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Eligibility criteria
Inclusion
Cohort 1: Able-Bodied Participants (Initial Validation)
Healthy young adults.
No history of neurological, orthopedic, or cardiovascular impairments affecting gait or balance.
Able to walk independently without assistive devices.
Individuals with a documented history of chronic stroke.
Persistent unilateral lower-limb motor impairment resulting in a pathological gait pattern (heterogeneous gait deficits).
Stable medical condition allowing for participation in intensive physical rehabilitation tasks.
Able to provide informed consent.
Exclusion
Severe cognitive or communication impairments that prevent the participant from following safety instructions or reporting discomfort.
Co-existing neurological conditions (other than stroke) that independently impair locomotion (e.g., Parkinson's disease, Multiple Sclerosis).
Severe lower-limb joint contractures or orthopedic conditions that mechanically restrict the safe range of motion of the robotic orthosis.
Skin breakdowns, open wounds, or severe unhealed lesions at the contact points where the powered orthosis interfaces with the lower limbs.
Any medical contraindication to intensive walking exercise or treadmill training (e.g., unstable angina, severe unmanaged cardiovascular disease).
What this trial measures
- Walking SpeedBaseline (Week 0), Post-Intervention Phase 1 (Week 4), Post-Washout / Pre-Intervention Phase 2 (Week 8), and Post-Intervention Phase 2 (Week 12).
A standardized clinical assessment used to determine short-distance walking speed over a 10-meter course. This metric evaluates the preliminary clinical efficacy of the unified control framework compared to the conventional controller in chronic stroke survivors.
- Functional Mobility and BalanceBaseline (Week 0), Post-Intervention Phase 1 (Week 4), Post-Washout / Pre-Intervention Phase 2 (Week 8), and Post-Intervention Phase 2 (Week 12).
A clinical performance-based measure used to assess dynamic balance, turning agility, and functional mobility. The test measures the time (in seconds) taken for a participant to rise from a chair, walk 3 meters, turn around, walk back, and sit down.