MOdularity for SEnsory Motor Control

Study Overview
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Brief Summary
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For this project the investigators ask, how the activation and organization of muscle synergies may be disrupted by brain lesions, and whether it is possible to modify synergy activations by means of specific therapies. Will be investigated whether there is a relationship between post-stroke cortical plasticity and changes in synergy activations due to a therapy.

Detailed Description
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It has been widely recognized that neurorehabilitation can facilitate recovery of motor function after stroke. There has been increasing evidence suggesting that the execution of voluntary movement relies critically on the functional integration of the motor areas and the spinal circuitries. More precisely, it was suggested that the central nervous system may generate neural motor commands through a linear combination of spinal modules, each of which activates a group of muscles as a single unit (muscle synergy). The investigators hypothesize that descending motor cortical signals generate movements by combining and activating muscle synergies. With this background, the goal is to further improve the efficacy of rehabilitation utilizing knowledge on modular motor control. The investigators also seek to provide a better understanding of the links between brain activations and movements. The project MO-SE has three aims, one primary and two secondary. The main primary aim is to test whether the use of virtual reality rehabilitation based therapies are superior in terms of clinical efficacy to conventional therapies (randomized clinica trial, RCT). The other two secondary aims of the project will be accomplished with further instrumental analysis in sub-samples of the group of patients enrolled for the RCT.

Official Title
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MOdularity for SEnsory Motor Control: Implications of Muscle Synergies in Motor Recovery After Stroke

Conditions
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Stroke, Ischemic, Upper Limb Injury, Rehabilitation

Intervention / Treatment
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* Device: Technology-aided rehabilitation
* Behavioral: Conventional rehabilitation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: diagnosis of first stroke; a score between 1 and 3 (included) at the upper limb sub-item on the Italian version of the National Institute of Health stroke scale (IT - NIHSS) (Pezzella et al., 2009) a score higher than 6 out of 66 on the Fugl - Meyer upper extremity (F-M UE) scale (Fugl-Meyer et al., 1975). Exclusion Criteria: the presence of a moderate cognitive decline defined as a Mini Mental State Examination (Folstein et al., 1975) score < 20/30 points; the finding of severe verbal comprehension deficit defined as a number of errors > 13 (Tau Points < 58/78) on the Token Test (Huber et al., 1984); evidence of apraxia and visuospatial neglect interfering with upper arm movements and manipulation of simple objects in all the directions within the visual field, as assessed through neurological examination; report in the patient's clinical history or evidence from the neurological examination of behavioural disturbances (i.e. delusions, aggressiveness and severe apathy/depression) that could affect compliance with the rehabilitation programs; non stabilised fractures; diagnosis of depression/delusion; associated traumatic brain injury; drug resistant epilepsy; evidence of ideomotor apraxia; evidence of visuospatial neglect; severe impairment of verbal comprehension defined as a score higher than 13 errors on Token test (i.e. score<58 out of 78 Tau points).

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

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
Interventional Model Description: Randomized Clinical Trial
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Technology-aided rehabilitation<br>The technology-aided upper limb rehabilitation include reinforced feedback in virtual environment (RFVE), or robotic therapy. | Device: Technology-aided rehabilitation<br>* VRRS involves performing different kinds of motor tasks with the patient holding a real manipulable object in their hands while interacting with a virtual scenario. Braccio di Ferro task consists in center-out reaching movements and return. The subject is required to start from a central target, reach one of five peripheral targets arranged on a semi-circle with a 20 cm radius and then return to the central target.<br>* Other names: Braccio di Ferro;|
| Active Comparator: Conventional rehabilitation<br>The conventional upper limb rehabilitation program will be based on traditional rehabilitation techniques aimed at restoring upper limb motor functions. | Behavioral: Conventional rehabilitation<br>* The patients will be asked to perform a wide range of exercises, including: shoulder flexion-extension, abduction-adduction, internal-external rotation, circumduction, elbow flexion-extension, forearm pronation-supination, hand-digit motion. Standardized instructions and modalities will be followed when providing exercises to the patients in order to control for any variability in leading the therapy session due to the therapist.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Fugl-Meyer Assessment Scale - Upper Extremity (construct: upper limb motor function) | Scale range scores: 0 - 66 points. Total summed score is reported with higher values representing a better outcome. | 20 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Functional Independence Measure (FIM) (construct: measure for independence in the activities of daily living - ADLs) | Scale range scores: 18 - 126 points. Total summed score is reported with higher values representing a better outcome. | 20 days | 
| Fugl-Meyer Assessment Scale - Range of Motion of Joints (construct: measure joints' passive range of motion) | Scale range scores: 0 - 44 points. Total summed score is reported with higher values representing a better outcome. | 20 days | 
| Fugl-Meyer Assessment Scale - Sensory Function (construct: measure of residual sensory function in upper and lower limbs affected by paresis) | Scale range scores: 0 - 24 points. Total summed score is reported with higher values representing a better outcome. | 20 days | 
| Fugl-Meyer Assessment Scale - Balance (construct: measure of impairment of standing and balance functions) | Scale range scores: 0 - 14 points. Total summed score is reported with higher values representing a better outcome. | 20 days | 
| Reaching Performance Scale (construct: measure of the ability to reach targets in the frontal space of upper limb affected by paresis) | Scale range scores: 0 - 36 points. Total summed score is reported with higher values representing a better outcome. | 20 days | 
| Modified Ashworth Scale (construct: measure of spasticity at the upper limb) | Scale range scores: 0 - 5 ranks. Total summed ranks are reported with higher values representing a worse outcome. | 20 days | 
| Box and Block Test | Measure of gross motor function of the hand and upper limb | 20 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Muscle Synergies, MRI, Virtual Reality, Robotics