Stroke
Conditions
Keywords
True recovery, Neurorehabilitation, Stroke
Brief summary
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.
Detailed 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.
Interventions
The intrevention is based in the training of the upper extremity movements without the restriction of DoF
The intervention is based in the training of a single DoF of the upper extremity with restriction of the rest DoF of the arm and trunk that aren't being trained being restrained by an exoskeleton
Sponsors
Study design
Masking description
The outcomes assessors will not now the arm to which each participant corresponds
Eligibility
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Functioning Outcome - function of the arm 3 | At week 12 | Scale scores of ARAT (Action Research Arm Test) |
| Functioning Outcome - function of the arm 4 | At week 24 | Scale scores of ARAT (Action Research Arm Test) |
| Normal movements Outcome. Kinematics of grasping and reaching 1 | At week 1 | Joint angles of the upper extremity in a water glass test |
| Normal movements Outcome. Kinematics of grasping and reaching 2 | At week 5 | Joint angles of the upper extremity in a water glass test |
| Normal movements Outcome. Kinematics of grasping and reaching 3 | At week 12 | Joint angles of the upper extremity in a water glass test |
| Normal movements Outcome. Kinematics of grasping and reaching 4 | At week 24 | Joint angles of the upper extremity in a glass test |
| Functioning Outcome 1 | At week 1 | Scale scores of Fugl Meyer Upper Limb test |
| Functioning Outcome 2 | At week 5 | Scale scores of Fugl Meyer Upper Limb test |
| Functioning Outcome 3 | At week 12 | Scale scores of Fugl Meyer Upper Limb test |
| Functioning Outcome 4 | At week 24 | Scale scores of Fugl Meyer Upper Limb test |
| Functioning Outcome - function of the arm1 | At week 1 | Scale scores of ARAT (Action Research Arm Test) |
| Functioning Outcome - function of the arm 2 | At week 5 | Scale scores of ARAT (Action Research Arm Test) |
| Functioning Outcome - daily life activities 1 | At week 1 | Scale scores of Barthel Index (independence in daily life activities) |
| Functioning Outcome - daily life activities 2 | At week 5 | Scale scores of Barthel Index (independence in daily life activities) |
| Functioning Outcome - daily life activities 3 | At week 12 | Scale scores of Barthel Index (independence in daily life activities) |
| Functioning Outcome - daily life activities 4 | At week 24 | Scale scores of Barthel Index (independence in daily life activities) |
| Functioning Outcome - quality of life 1 | At week 1 | Scale scores of EQ-5D (quality of life test) |
| Functioning Outcome - quality of life 2 | At week 5 | Scale scores of EQ-5D (quality of life test) |
| Functioning Outcome - quality of life 3 | At week 12 | Scale scores of EQ-5D (quality of life test) |
| Functioning Outcome - quality of life 4 | At week 24 | Scale scores of EQ-5D (quality of life test) |
| Connectivity Outcome 1 | At week 1 | Interhermispheric coherence of beta bands in the EEG. |
| Connectivity Outcome 2 | At week 5 | Interhermispheric coherence of beta bands in the EEG. |
| Connectivity Outcome 3 | At week 12 | Interhermispheric coherence of beta bands in the EEG. |
| Connectivity Outcome 4 | At week 24 | Interhermispheric coherence of beta bands in the EEG. |
Countries
Chile