Rehabilitation Clinical Trial
— MOSEOfficial title:
MOdularity for SEnsory Motor Control: Implications of Muscle Synergies in Motor Recovery After Stroke
Verified date | June 2022 |
Source | IRCCS San Camillo, Venezia, Italy |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Active, not recruiting |
Enrollment | 132 |
Est. completion date | December 1, 2022 |
Est. primary completion date | December 1, 2018 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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). |
Country | Name | City | State |
---|---|---|---|
Italy | IRCCS Fondazione Don Gnocchi Onlus | Milan | |
Italy | IRCCS San Camillo, Venezia, Italy | Venice |
Lead Sponsor | Collaborator |
---|---|
IRCCS San Camillo, Venezia, Italy | Fondazione Don Carlo Gnocchi Onlus |
Italy,
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* Note: There are 27 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Mean duration [s] | Time needed to execute standard motor tasks | 20 days | |
Other | Mean velocity [cm/s] | Velocity expressed to execute standard motor tasks | 20 days | |
Other | Smoothness [number of submovements] | Smoothness expressed to execute standard motor tasks | 20 days | |
Other | Muscle synergies [n] | Number of muscular patterns recognised by processing of surface electromyography data to execute standard motor tasks | 20 days | |
Primary | 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 | 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 | |
Secondary | 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 | |
Secondary | 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 | |
Secondary | 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 | |
Secondary | 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 | |
Secondary | 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 | |
Secondary | Box and Block Test | Measure of gross motor function of the hand and upper limb | 20 days |
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