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| ID | Type | Description | Link |
|---|---|---|---|
| 11181337 | Other Grant/Funding Number | Fondecyt ANID |
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| Name | Class |
|---|---|
| Fondo Nacional de Desarrollo CientÃfico y Tecnológico, Chile | OTHER_GOV |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Controlled DoF | Experimental | The treatment that this gruop will receive consist in a training with the exoskeleton that will restrict the DoF of the arm and trunk |
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| Non controlled DoF | Active Comparator | The treatment that this gruop will receive consist in a training with out the exoskeleton and without restriction of the DoF |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Training with restriction of the DoF | Behavioral | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Normal movements Outcome. Kinematics of grasping and reaching 1 | Joint angles of the upper extremity in a water glass test | At week 1 |
| Normal movements Outcome. Kinematics of grasping and reaching 2 | Joint angles of the upper extremity in a water glass test | At week 5 |
| Normal movements Outcome. Kinematics of grasping and reaching 3 | Joint angles of the upper extremity in a water glass test | At week 12 |
| Normal movements Outcome. Kinematics of grasping and reaching 4 | Joint angles of the upper extremity in a glass test | At week 24 |
| Functioning Outcome 1 | Scale scores of Fugl Meyer Upper Limb test | At week 1 |
| Functioning Outcome 2 | Scale scores of Fugl Meyer Upper Limb test | At week 5 |
| Functioning Outcome 3 | Scale scores of Fugl Meyer Upper Limb test | At week 12 |
| Functioning Outcome 4 | Scale scores of Fugl Meyer Upper Limb test | At week 24 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Pedro Maldonado, Doctor | University of Chile | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital ClÃnico Universidad de Chile | Santiago | 8320000 | Chile |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| ICF | No | No | Yes | Informed Consent Form | Jun 19, 2019 | May 7, 2022 | ICF_000.pdf |
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| ID | Term |
|---|---|
| D020521 | Stroke |
| ID | Term |
|---|---|
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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The outcomes assessors will not now the arm to which each participant corresponds
| Training without restriction of the DoF | Behavioral | The intrevention is based in the training of the upper extremity movements without the restriction of DoF |
|
| Functioning Outcome - function of the arm1 | Scale scores of ARAT (Action Research Arm Test) | At week 1 |
| Functioning Outcome - function of the arm 2 | Scale scores of ARAT (Action Research Arm Test) | At week 5 |
| Functioning Outcome - function of the arm 3 | Scale scores of ARAT (Action Research Arm Test) | At week 12 |
| Functioning Outcome - function of the arm 4 | Scale scores of ARAT (Action Research Arm Test) | At week 24 |
| Functioning Outcome - daily life activities 1 | Scale scores of Barthel Index (independence in daily life activities) | At week 1 |
| Functioning Outcome - daily life activities 2 | Scale scores of Barthel Index (independence in daily life activities) | At week 5 |
| Functioning Outcome - daily life activities 3 | Scale scores of Barthel Index (independence in daily life activities) | At week 12 |
| Functioning Outcome - daily life activities 4 | Scale scores of Barthel Index (independence in daily life activities) | At week 24 |
| Functioning Outcome - quality of life 1 | Scale scores of EQ-5D (quality of life test) | At week 1 |
| Functioning Outcome - quality of life 2 | Scale scores of EQ-5D (quality of life test) | At week 5 |
| Functioning Outcome - quality of life 3 | Scale scores of EQ-5D (quality of life test) | At week 12 |
| Functioning Outcome - quality of life 4 | Scale scores of EQ-5D (quality of life test) | At week 24 |
| Connectivity Outcome 1 | Interhermispheric coherence of beta bands in the EEG. | At week 1 |
| Connectivity Outcome 2 | Interhermispheric coherence of beta bands in the EEG. | At week 5 |
| Connectivity Outcome 3 | Interhermispheric coherence of beta bands in the EEG. | At week 12 |
| Connectivity Outcome 4 | Interhermispheric coherence of beta bands in the EEG. | At week 24 |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |