ExoDoF: Robotic Exoskeleton for Upper Limb Motor Rehabilitation After Stroke

NCT ID: NCT06496529

Last Updated: 2025-12-30

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 44 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-03-01
• Study Completion Date: 2026-11-30

Brief 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.

Conditions

Stroke

Keywords

stroke recovery; motor recovery; upper extremity recovery

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

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.

Group Type: EXPERIMENTAL

DoF intervention

Intervention Type: BEHAVIORAL

Training of specific uniarticular and single plane movement of the upper limb through an exoskeleton and videogames that will be supervised by a physiotherapist.

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.

Group Type: ACTIVE_COMPARATOR

Task intervention

Intervention Type: BEHAVIORAL

Training of multiarticular upper limb movements (vertical, horizontal and diagonal) through videogames and also training of functional task (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). This activities will be supervised by a physiotherapist.

Interventions

DoF intervention

Training of specific uniarticular and single plane movement of the upper limb through an exoskeleton and videogames that will be supervised by a physiotherapist.

Intervention Type: BEHAVIORAL

Task intervention

Training of multiarticular upper limb movements (vertical, horizontal and diagonal) through videogames and also training of functional task (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). This activities will be supervised by a physiotherapist.

Intervention Type: BEHAVIORAL

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)

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 81 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Agencia Nacional de Investigación y Desarrollo

OTHER

Sponsor Role: collaborator

University of Chile

OTHER

Sponsor Role: lead

Responsible Party

Pablo Burgos

Principal Investigator. Ph.D, PT.

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Pablo Burgos, PhD

Role: STUDY_DIRECTOR

University of Chile

Locations

Hospital Clínico Universidad de Chile

Santiago, , Chile

Site Status: RECRUITING

Hospital El Carmen

Santiago, , Chile

Site Status: RECRUITING

Hospital San José

Santiago, , Chile

Site Status: RECRUITING

Hospital Dr. Hernán Henríquez Aravena

Temuco, , Chile

Site Status: RECRUITING

Countries

Chile

Central Contacts

Pablo Burgos, PhD

Role: CONTACT

Phone: 19713314101

Email: pburgos@uchile.cl

Juan José Mariman, PhD

Role: CONTACT

Phone: +56981928168

Email: juan.mariman@umce.cl

Facility Contacts

Hachi Manzur, Ph.D

Role: primary

Daniel Bustos, PT

Role: primary

Natalia Gonzalez, PT

Role: primary

Pablo Hernández, PT

Role: primary

Other Identifiers

FONDEF IDeA 2023 ID23I104

Identifier Type: -

Identifier Source: org_study_id