ExoDoF: Robotic Exoskeleton for Upper Limb Motor Rehabilitation After Stroke

University of Chile

Status: Enrolling

Conditions: Stroke

Treatments: Behavioral: Task intervention; Behavioral: DoF intervention

Study type: Interventional

Funder types: Other

Identifiers

NCT06496529

FONDEF IDeA 2023 ID23I104

Details and patient eligibility

About

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.

Enrollment: 44 estimated patients

Sex: All

Ages: 18 to 81 years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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44 participants in 2 patient groups

DoF Group

Experimental group

Description:

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.

Treatment:

Behavioral: DoF intervention

Task Group

Active Comparator group

Description:

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.

Treatment:

Behavioral: Task intervention