Actively Recruiting

Phase Not Applicable
Age: 18Years - 81Years
All Genders
NCT06496529

ExoDoF: Robotic Exoskeleton for Upper Limb Motor Rehabilitation After Stroke

Led by University of Chile · Updated on 2025-12-30

44

Participants Needed

4

Research Sites

91 weeks

Total Duration

On this page

Sponsors

U

University of Chile

Lead Sponsor

A

Agencia Nacional de Investigación y Desarrollo

Collaborating Sponsor

AI-Summary

What this Trial Is About

Two decades ago, the projection of recovery of the upper extremity (UE) after a stroke had a very poor prognosis worldwide. Nowadays, thanks to medical advances and early rehabilitation, the prognosis for recovery has improved; however, there is still a limit that no therapy has been able to overcome, related to spontaneous recovery as part of the natural evolution of the pathophysiological process, rather than with the contribution of rehabilitation. Additionally, existing therapies show partial effectiveness on the recovery of UE function, but do not avoid the use of compensatory strategies or alternatives to normal movement. Given this situation, there is an active search for new therapeutic approaches. In this clinical trial the investigators propose a rehabilitation paradigm that promotes the recovery of control of specific planes of movement through the selective restriction of degrees of freedom, simplifying control demands. The investigators sought to test the hypothesis that people with stroke in the early subacute stage and who present alterations in the movement of the upper extremity, a rehabilitation protocol that reduces the degrees of freedom of the UE and trunk, enables greater recovery of the movement of the UE and less use of compensatory movements compared to a protocol without DoF control. The general objective is to demonstrate the effect of training with restriction of the degrees of freedom of UE and trunk, mediated by an exoskeleton and videogames, on the control of the UE.

CONDITIONS

Official Title

ExoDoF: Robotic Exoskeleton for Upper Limb Motor Rehabilitation After Stroke

Who Can Participate

Age: 18Years - 81Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Diagnosis of ischemic or hemorrhagic stroke with zero to twelve weeks of evolution
  • Alterations in active voluntary movement of upper limb with Fugl Meyer score less than or equal to 50 points
  • Shoulder abduction and finger extension muscle strength from palpable contraction (1 on Medical Research Council scale)
Not Eligible

You will not qualify if you...

  • Cognitive impairment preventing consent or following instructions (MOCA < 18)
  • Inability to sit for more than 90 minutes or perform activities without severe pain (VAS > 6) or with limited reach
  • Severe visual impairment preventing task performance
  • Previous stroke with neurological sequelae in the upper extremity
  • Bilateral sensorimotor alterations
  • Cerebellum or peduncle damage described in radiology or signs of cerebellar damage (Upper extremity SARA items of 2 or more)

AI-Screening

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Trial Site Locations

Total: 4 locations

1

Hospital Clínico Universidad de Chile

Santiago, Chile

Actively Recruiting

2

Hospital El Carmen

Santiago, Chile

Actively Recruiting

3

Hospital San José

Santiago, Chile

Actively Recruiting

4

Hospital Dr. Hernán Henríquez Aravena

Temuco, Chile

Actively Recruiting

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Research Team

P

Pablo Burgos, PhD

CONTACT

J

Juan José Mariman, PhD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

DOUBLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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