Control of Degrees of Freedom Post-stroke for the Recovery of the Upper Limb (DoF_UL_S)

University of Chile

Status

Completed

Conditions

Stroke

Treatments

Behavioral: Training without restriction of the DoF

Behavioral: Training with restriction of the DoF

Study type

Interventional

Funder types

Other

Identifiers

NCT05371444

11181337 (Other Grant/Funding Number)

hcuch_038

Details and patient eligibility

About

The study's methodology will be a single-blind, multicenter, parallel-group randomized controlled trial (RCT). The sample consists of stroke patients (supratentorial ischemic and hemorrhagic stroke of anterior territory) between 18 and 80 years of age, separated into 2 groups of 20 participants. The experimental group called "controlled DoF", the control group 1 called "non controlled DoF". The "controlled DoF" group will use an exoskeleton that will restrict the movement of the trunk and upper limb to release only the joint to work in the plane of interest. The "non-controlled DoF" group will receive the same therapy time as the previous group but without any restriction of joint movements. The training will be functional with multiarticular and combined planes tasks. All groups receive the conventional rehabilitation of the health center (ideally 45 minutes 1 per day). Using motion sensors, clinical scales, and electroencephalography (EEG), the data will be obtained pre-intervention, post-intervention, and in a follow-up at 3 and 6 months.

Full description

This proposal seeks to demonstrate if the control of joint degrees of freedom (DoF) of the trunk and upper limb is determinant during the early rehabilitation phase post-stroke (here from day 1 to day 28 or first month) for the recovery of upper limb movements without compensations and the normal brain control (true recovery).

The study's methodology will be a single-blind, multicenter, parallel-group randomized controlled trial (RCT). The sample consists of stroke patients (supratentorial ischemic and hemorrhagic stroke of anterior territory) between 18 and 80 years of age, separated into 2 groups of 20 participants. The experimental group called "controlled DoF", the control group 1 called "non controlled DoF". The "controlled DoF" group will receive for the initial 2 weeks, 2 hours of therapy, 5 times a week (2 sessions of 1 hour per day, 5 days) and the next 2 weeks, 2 hours of therapy, 3 times a week(2 sessions of 1 hour of therapy, 3 days), using an exoskeleton that will restrict the movement of the trunk and upper limb to release only the joint to work in the plane of interest. The training will be selective in an articulation plane with the biofeedback of active movements (or active-assisted) employing a video game controlled by an external movement sensor installed in the segment of interest. The "non-controlled DoF" group will receive the same therapy time as the previous group but without any restriction of joint movements. The training will be functional with multiarticular and combined planes tasks. All groups receive the conventional rehabilitation of the health center (ideally 45 minutes 1 per day). Using motion sensors, clinical scales, and electroencephalography (EEG), the data will be obtained pre-intervention, post-intervention, and in a follow-up at 3 and 6 months.

The expected results would show more functional improvements with less compensatory kinematics for therapy that control DoF than for the therapy without control of the DoF or for conventional therapy in acute post-stroke patients. About this result, the EEG connectivity analysis would show a lower interhemispheric inhibition of the motor areas and a greater frontal-parietal flow during reaching and manipulation tasks in the group with DoF control.

Enrollment

45 patients

Sex

All

Ages

18 to 80 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

(1) Clinical diagnosis of supratentorial ischemic stroke.
(2) Time of onset <72 hours.
(3) With alterations of the active voluntary movement of UL.
(4) At least 3/8 DoF of the UE with MRC force scale of 3 or less.

Exclusion criteria

(1) Cognitive impairment that prevents signing informed consent, following instructions and understanding procedures. (MoCA ≥ 18).
(2) Musculoskeletal pathologies that prevent activities without pain or with limited ranges for the scope.
(3) Severe visual impairment that does not allow the activities associated with the task.
(4) Cerebellar o brainstem stroke.
(5) Previous stroke leaving upper limb impairment.
(6) Bilateral sensorimotor alterations.
(7) Do not present alterations in functional clinical tests.