Robotic exoskeleton to improve arm and hand movement after stroke.

ExoDoF: Robotic Exoskeleton for Upper Limb Motor Rehabilitation After Stroke

This trial will test whether a robotic exoskeleton that selectively limits certain arm movements can help people within 0–12 weeks after ischemic or hemorrhagic stroke regain better upper‑limb control.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 44 (estimated)
• Ages: 18 Years to 81 Years
• Sex: All
• Sponsor: University of Chile (other)
• Locations: 4 sites (Santiago and 3 other locations)
• Trial ID: NCT06496529 on ClinicalTrials.gov

What this trial studies

The trial uses a robotic exoskeleton that selectively restricts degrees of freedom to simplify motor control while patients perform task‑specific training aimed at restoring movement in specific planes. Participants are people early after stroke (0–12 weeks) with measurable upper‑limb weakness and limited voluntary movement. Therapy sessions combine the exoskeleton's movement constraints with repetitive task practice to encourage recovery of normal movement patterns and reduce compensatory strategies. Outcomes focus on changes in upper‑limb motor control and function measured before and after the intervention period.

Who should consider this trial

Good fit: Ideal candidates are adults 0–12 weeks after an ischemic or hemorrhagic stroke with impaired voluntary upper‑limb movement (Fugl‑Meyer ≤50) and at least palpable shoulder abduction and finger extension (MRC ≥1), who can sit for therapy and understand instructions.

Not a fit: Patients with significant cognitive impairment (MOCA <18), severe pain or inability to sit for therapy, severe visual impairment, bilateral sensorimotor deficits, prior stroke with lasting upper‑limb deficits, or cerebellar/peduncular damage are unlikely to benefit or be eligible.

Why it matters

Potential benefit: If successful, this approach could improve arm and hand motor recovery beyond spontaneous recovery and reduce reliance on compensatory movements.

How similar studies have performed: Other robotic and constraint‑based upper‑limb therapies have produced modest improvements in motor recovery, but selectively restricting degrees of freedom with an exoskeleton is a relatively novel approach.

Eligibility criteria

Inclusion Criteria:

* Diagnosis of ischemic or hemorrhagic stroke with zero to twelve weeks of evolution.
* Subjects with alterations in active voluntary movement of ES with Fugl Meyer less than or equal to 50 points. Strength of shoulder abduction and finger extension from palpable contraction (1 in Medical Research Council (MRC) scale for muscle strength).

Exclusion Criteria:

* Cognitive impairment that prevents signing the informed consent, following the instructions and understanding the procedures. (MOCA \< 18).
* Inability to perform activities sitting for more than 90 minutes or inability to perform activities without severe pain (VAS \> 6) or having limited reach ranges.
* Have severe visual impairment that does not allow to carry out the activities associated with the task.
* Previous stroke with neurological sequelae in the upper extremity.
* Present bilateral sensorimotor alterations.
* Damage to the cerebellum/peduncles described in the radiological report or classic signs of cerebellar damage (Upper extremity SARA items of 2 or more)

Where this trial is running

Santiago and 3 other locations

• Hospital Clínico Universidad de Chile — Santiago, Chile (RECRUITING)
• Hospital El Carmen — Santiago, Chile (RECRUITING)
• Hospital San José — Santiago, Chile (RECRUITING)
• Hospital Dr. Hernán Henríquez Aravena — Temuco, Chile (RECRUITING)

Study contacts

• Study coordinator: Pablo Burgos, PhD

Conditions: Stroke, stroke recovery, motor recovery, upper extremity recovery