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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
45
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
The intrevention is based in the training of the upper extremity movements without the restriction of DoF
Hospital Clínico Universidad de Chile
Santiago, Chile
Normal movements Outcome. Kinematics of grasping and reaching 1
Joint angles of the upper extremity in a water glass test
Time frame: At week 1
Normal movements Outcome. Kinematics of grasping and reaching 2
Joint angles of the upper extremity in a water glass test
Time frame: At week 5
Normal movements Outcome. Kinematics of grasping and reaching 3
Joint angles of the upper extremity in a water glass test
Time frame: At week 12
Normal movements Outcome. Kinematics of grasping and reaching 4
Joint angles of the upper extremity in a glass test
Time frame: At week 24
Functioning Outcome 1
Scale scores of Fugl Meyer Upper Limb test
Time frame: At week 1
Functioning Outcome 2
Scale scores of Fugl Meyer Upper Limb test
Time frame: At week 5
Functioning Outcome 3
Scale scores of Fugl Meyer Upper Limb test
Time frame: At week 12
Functioning Outcome 4
Scale scores of Fugl Meyer Upper Limb test
Time frame: At week 24
Functioning Outcome - function of the arm1
Scale scores of ARAT (Action Research Arm Test)
Time frame: At week 1
Functioning Outcome - function of the arm 2
Scale scores of ARAT (Action Research Arm Test)
Time frame: At week 5
Functioning Outcome - function of the arm 3
Scale scores of ARAT (Action Research Arm Test)
Time frame: At week 12
Functioning Outcome - function of the arm 4
Scale scores of ARAT (Action Research Arm Test)
Time frame: At week 24
Functioning Outcome - daily life activities 1
Scale scores of Barthel Index (independence in daily life activities)
Time frame: At week 1
Functioning Outcome - daily life activities 2
Scale scores of Barthel Index (independence in daily life activities)
Time frame: At week 5
Functioning Outcome - daily life activities 3
Scale scores of Barthel Index (independence in daily life activities)
Time frame: At week 12
Functioning Outcome - daily life activities 4
Scale scores of Barthel Index (independence in daily life activities)
Time frame: At week 24
Functioning Outcome - quality of life 1
Scale scores of EQ-5D (quality of life test)
Time frame: At week 1
Functioning Outcome - quality of life 2
Scale scores of EQ-5D (quality of life test)
Time frame: At week 5
Functioning Outcome - quality of life 3
Scale scores of EQ-5D (quality of life test)
Time frame: At week 12
Functioning Outcome - quality of life 4
Scale scores of EQ-5D (quality of life test)
Time frame: At week 24
Connectivity Outcome 1
Interhermispheric coherence of beta bands in the EEG.
Time frame: At week 1
Connectivity Outcome 2
Interhermispheric coherence of beta bands in the EEG.
Time frame: At week 5
Connectivity Outcome 3
Interhermispheric coherence of beta bands in the EEG.
Time frame: At week 12
Connectivity Outcome 4
Interhermispheric coherence of beta bands in the EEG.
Time frame: At week 24
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