ExoDoF: Robotic Exoskeleton for Upper Limb Motor Rehabilitation After Stroke

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.

Study Overview

• Status: Recruiting
• Conditions: Stroke
• Intervention / Treatment: Behavioral: DoF intervention; Behavioral: Task intervention

• Study Type: Interventional
• Enrollment (Estimated): 44
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Pablo Burgos, PhD; Phone Number: 19713314101; Email: pburgos@uchile.cl
• Study Contact Backup: Name: Juan José Mariman, PhD; Phone Number: +56981928168; Email: juan.mariman@umce.cl

Study Locations

• Chile
  • Santiago, Chile
    • Recruiting
    • Hospital Clínico Universidad de Chile
    • Contact: Hachi Manzur, Ph.D; Phone Number: +56 9 8192 8168; Email: hemanzur@gmail.com
  • Santiago, Chile
    • Recruiting
    • Hospital El Carmen
    • Contact: Daniel Bustos, PT; Phone Number: +56 9 7754 9193; Email: daniel.bustos.c@usach.cl
  • Santiago, Chile
    • Recruiting
    • Hospital San José
    • Contact: Natalia Gonzalez, PT; Phone Number: +56 9 8154 8009; Email: nataliagonzaleznunes@gmail.com
  • Temuco, Chile
    • Recruiting
    • Hospital Dr. Hernán Henríquez Aravena
    • Contact: Pablo Hernández, PT; Phone Number: +56 9 7853 9892; Email: klgo.pablohernandez@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.	Behavioral: 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.
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.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in UE-FMA at the end of the training	Differences between the Upper Extremity Fugl-Meyer Assessment (UE-FMA) at the beginning of the recruitment and at the end of the training	3 days post training
Change in UE-FMA at 6 months post stroke	Differences between the Upper Extremity Fugl-Meyer Assessment (UE-FMA) at the beginning of the recruitment and at 6 months post stroke	180 days post stroke

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in ARAT at the end of the training	Differences between the Action Research Arm Test (ARAT) at the beginning of the recruitment and at the end of the training	3 days post training
Change in ARAT at 6 months post stroke	Differences between the Action Research Arm Test (ARAT) at the beginning of the recruitment and at 6 months post stroke	180 days post stroke
Change in iCoh at the end of the training	Differences between EEG Ipsi-Contralateral Motor Cortex connectivity (iCoh) at the beginning of the training and at the end of the training	3 days post training
Change in iCoh connectivity at 6 months post stroke	Differences between EEG Ipsi-Contralateral Motor Cortex connectivity (iCoh) at the beginning of the training and at 6 months post stroke	180 days post stroke
Change in arm kinematics at the end of the training	Differences between arm kinematics (shoulder, elbow, wrist and finger angles during reaching and grasping a glass) at the beginning of the training and at the end of the training	3 days post training
Change in arm kinematics at 6 months post stroke	Differences between arm kinematics (shoulder, elbow, wrist and finger angles during reaching and grasping a glass) at the beginning of the training and at 6 months post stroke	180 days post stroke

Collaborators and Investigators

• Sponsor: University of Chile
• Collaborators: Agencia Nacional de Investigación y Desarrollo
• Investigators: Study Director: Pablo Burgos, PhD, University of Chile

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2025
• Primary Completion (Estimated): November 30, 2026
• Study Completion (Estimated): November 30, 2026

Study Registration Dates

• First Submitted: July 3, 2024
• First Submitted That Met QC Criteria: July 3, 2024
• First Posted (Actual): July 11, 2024

Study Record Updates

• Last Update Posted (Actual): December 30, 2025
• Last Update Submitted That Met QC Criteria: December 22, 2025
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Keywords: stroke recovery; motor recovery; upper extremity recovery
• Additional Relevant MeSH Terms: Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Stroke
• Other Study ID Numbers: FONDEF IDeA 2023 ID23I104

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: all collected IPD
• IPD Sharing Time Frame: After the publication of the clinical trial, for 5 years.
• IPD Sharing Access Criteria: Based on reasonable request to the project director (Pablo Burgos, pburgos@uchile.cl), the data will be shared.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ANALYTIC_CODE

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No