ExoDoF: Robotic Exoskeleton for Upper Limb Motor Rehabilitation After Stroke

Last updated: July 15, 2024
Sponsor: University of Chile
Overall Status: Active - Not Recruiting

Phase

N/A

Condition

Stroke

Cerebral Ischemia

Treatment

Task intervention

DoF intervention

Clinical Study ID

NCT06496529
FONDEF IDeA 2023 ID23I104
  • Ages > 18
  • All Genders

Study Summary

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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Diagnosis of ischemic or hemorrhagic stroke with zero to six weeks of evolution.

  • Subjects with alterations in active voluntary movement of ES with Fugl Meyer lessthan or equal to 50 points. Strength of shoulder abduction or finger extension frompalpable contraction (1 in Medical Research Council (MRC) scale for musclestrength).

Exclusion

Exclusion Criteria:

  • Cognitive impairment that prevents signing the informed consent, following theinstructions and understanding the procedures. (MOCA < 18).

  • Inability to perform activities sitting for more than 90 minutes or inability toperform activities without severe pain (VAS > 6) or having limited reach ranges.

  • Have severe visual impairment that does not allow to carry out the activitiesassociated 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 classicsigns of cerebellar damage (Upper extremity SARA items of 2 or more)

Study Design

Total Participants: 44
Treatment Group(s): 2
Primary Treatment: Task intervention
Phase:
Study Start date:
August 01, 2024
Estimated Completion Date:
May 31, 2025