Clinical trial NCT03530358: MOdularity for SEnsory Motor Control
Official title: MOdularity for SEnsory Motor Control: Implications of Muscle Synergies in Motor Recovery After Stroke
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Stroke, Ischemic
Upper Limb Injury
Rehabilitation
Keywords: Muscle Synergies
MRI
Virtual Reality
Robotics
Lead sponsor: IRCCS San Camillo, Venezia, Italy
Sponsor class: OTHER
Collaborators: name: Fondazione Don Carlo Gnocchi Onlus
First posted: 2018-05-21
Enrollment: 132
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized Clinical Trial
Primary purpose: TREATMENT

Brief summary: 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: 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.

Eligibility criteria: 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).

Primary outcomes:
measure: Fugl-Meyer Assessment Scale - Upper Extremity (construct: upper limb motor function)
timeFrame: 20 days
Secondary outcomes:
measure: Functional Independence Measure (FIM) (construct: measure for independence in the activities of daily living - ADLs)
timeFrame: 20 days
measure: Fugl-Meyer Assessment Scale - Range of Motion of Joints (construct: measure joints' passive range of motion)
timeFrame: 20 days
measure: Fugl-Meyer Assessment Scale - Sensory Function (construct: measure of residual sensory function in upper and lower limbs affected by paresis)
timeFrame: 20 days
measure: Fugl-Meyer Assessment Scale - Balance (construct: measure of impairment of standing and balance functions)
timeFrame: 20 days
measure: Reaching Performance Scale (construct: measure of the ability to reach targets in the frontal space of upper limb affected by paresis)
timeFrame: 20 days
measure: Modified Ashworth Scale (construct: measure of spasticity at the upper limb)
timeFrame: 20 days
measure: Box and Block Test
timeFrame: 20 days
Other outcomes:
measure: Mean duration [s]
timeFrame: 20 days
measure: Mean velocity [cm/s]
timeFrame: 20 days
measure: Smoothness [number of submovements]
timeFrame: 20 days
measure: Muscle synergies [n]
timeFrame: 20 days
Locations:
city: Milan
country: Italy
facility: IRCCS Fondazione Don Gnocchi Onlus
city: Venice
country: Italy
facility: IRCCS San Camillo, Venezia, Italy
Study officials:
affiliation: IRCCS San Camillo, Venezia, Italy
name: Andrea Turolla, PhD
role: PRINCIPAL_INVESTIGATOR
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