ExoDoF: Robotic Exoskeleton for Upper Limb Motor Rehabilitation After Stroke

Status: Recruiting
Location: See all (4) locations...
Intervention Type: Behavioral
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 81
Healthy Volunteers: f
View:

• 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).

Locations
Other Locations
Chile
Hospital Clínico Universidad de Chile
RECRUITING
Santiago
Hospital El Carmen
RECRUITING
Santiago
Hospital San José
RECRUITING
Santiago
Hospital Dr. Hernán Henríquez Aravena
RECRUITING
Temuco
Contact Information
Primary
Pablo Burgos, PhD
pburgos@uchile.cl
19713314101
Backup
Juan José Mariman, PhD
juan.mariman@umce.cl
+56981928168
Time Frame
Start Date: 2025-03-01
Estimated Completion Date: 2026-11-30
Participants
Target number of participants: 44
Treatments
Experimental: DoF Group
The experimental group with control of the degrees of freedom will receive treatment for 4 weeks using an exoskeleton and also it will be supervised by a physiotherapist.The exoskeleton will restrict the movement of the trunk and upper extremity to leave only the joint free to work in the plane of interest. The training will be selective in an articular plane with biofeedback of movement through videogames and external movement sensors installed in the upper extremity. This movement sensor will allow to interact with the videogames through the movement of the trained movement.
Active_comparator: Task Group
The group without control of the degrees of freedom (Task Group) will receive a therapeutic intervention equivalent in dose, but without any restriction of joint movement (without the exoskeleton). Each session will be divided into two parts. In the first part, participants will train with combined planes and in a multi-joint manner with the same video games as DoF Group but with the movement sensor in your hand performing 4 direction movements with the upper limb (horizontal, vertical and diagonals).~In the second training part, patients will perform functional tasks: raise and lower your hand on the table, cleaning a table, put cream on the non-paretic arm, hold a bottle, put a piece of bread or something similar in your mouth, wash your face, brush your hair, store items in a basket, brush teeth, wrote and serve water in glass.
Related Therapeutic Areas
Sponsors
Leads: University of Chile
Collaborators: Agencia Nacional de Investigación y Desarrollo

This content was sourced from clinicaltrials.gov