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NCT Number: NCT06496529

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.

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Key information

Age range

18 year–81 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hospital Clínico Universidad de Chile, Santiago, Chile

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

DoF intervention

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 intervention

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.

Primary outcomes

  1. Change in UE-FMA at the end of the training

    Time frame: 3 days post training

    Differences between the Upper Extremity Fugl-Meyer Assessment (UE-FMA) at the beginning of the recruitment and at the end of the training

  2. Change in UE-FMA at 6 months post stroke

    Time frame: 180 days post stroke

    Differences between the Upper Extremity Fugl-Meyer Assessment (UE-FMA) at the beginning of the recruitment and at 6 months post stroke

Secondary outcomes

  1. Change in ARAT at the end of the training

    Time frame: 3 days post training

    Differences between the Action Research Arm Test (ARAT) at the beginning of the recruitment and at the end of the training

  2. Change in ARAT at 6 months post stroke

    Time frame: 180 days post stroke

    Differences between the Action Research Arm Test (ARAT) at the beginning of the recruitment and at 6 months post stroke

  3. Change in iCoh at the end of the training

    Time frame: 3 days post training

    Differences between EEG Ipsi-Contralateral Motor Cortex connectivity (iCoh) at the beginning of the training and at the end of the training

  4. Change in iCoh connectivity at 6 months post stroke

    Time frame: 180 days post stroke

    Differences between EEG Ipsi-Contralateral Motor Cortex connectivity (iCoh) at the beginning of the training and at 6 months post stroke

  5. Change in arm kinematics at the end of the training

    Time frame: 3 days post 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

  6. Change in arm kinematics at 6 months post stroke

    Time frame: 180 days 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

Study contacts

Contact information is provided by the study sponsor or research team.

Juan José Mariman, PhD

CONTACT

[email protected]

+56981928168

Pablo Burgos, PhD

CONTACT

[email protected]

19713314101

Sponsors and collaborators

Lead sponsor

University of Chile

Other

Collaborators

  • Agencia Nacional de Investigación y Desarrollo

Registry information

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Jul 11, 2024
Registry last updated
Dec 30, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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