ExoDoF: Robotic Exoskeleton for Upper Limb Motor Rehabilitation After Stroke

Overview

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.

Interventions

• 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.
• 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.

Primary outcome measures

• Change in UE-FMA at the end of the training [Time frame: 3 days post training]
• Change in UE-FMA at 6 months post stroke [Time frame: 180 days post stroke]

Secondary outcome measures (6)

• Change in ARAT at the end of the training [Time frame: 3 days post training]
• Change in ARAT at 6 months post stroke [Time frame: 180 days post stroke]
• Change in iCoh at the end of the training [Time frame: 3 days post training]
• Change in iCoh connectivity at 6 months post stroke [Time frame: 180 days post stroke]
• Change in arm kinematics at the end of the training [Time frame: 3 days post training]
• Change in arm kinematics at 6 months post stroke [Time frame: 180 days post stroke]

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)

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Double blind

Primary purpose

Treatment

Study locations

Chile · 4 centers

• Hospital Clínico Universidad de Chile — Santiago
• Hospital El Carmen — Santiago
• Hospital San José — Santiago
• Hospital Dr. Hernán Henríquez Aravena — Temuco

Identifiers

NCT: NCT06496529 · FONDEF IDeA 2023 ID23I104

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗