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

Study Overview
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Brief Summary
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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 3 groups of 20 participants. The experimental group called controlled DoF, the control group 1 called non controlled DoF and the control group 2 called Conventional. 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) and the Conventional group receives only this intervention. 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
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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 3 groups of 20 participants. The experimental group called controlled DoF, the control group 1 called non controlled DoF and the control group 2 called Conventional. 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) and the Conventional group only receives this intervention. 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.

Official Title
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Effects of Control of Joint Degrees of Freedom in the Early Rehabilitation Post-stroke for the Recovery of Normal Movement (Non-compensatory) of the Upper Limb

Conditions
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Stroke

Intervention / Treatment
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* Behavioral: Training with restriction of the DoF
* Behavioral: Training without restriction of the DoF


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Controlled DoF<br>The treatment that this gruop will receive consist in a training with the exoskeleton that will restrict the DoF of the arm and trunk | Behavioral: Training with restriction of the DoF<br>* 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<br>|
| Active Comparator: Non controlled DoF<br>The treatment that this gruop will receive consist in a training with out the exoskeleton and without restriction of the DoF | Behavioral: Training without restriction of the DoF<br>* The intrevention is based in the training of the upper extremity movements without the restriction of DoF<br>|
| No Intervention: Conventional<br>This group will only recieve the conventional therapy that is given by the medical center | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Stroke, True recovery, Neurorehabilitation