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MOdularity for SEnsory Motor Control (MOSE)

Primary Purpose

Stroke, Ischemic, Upper Limb Injury, Rehabilitation

Status
Active
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
Technology-aided rehabilitation
Conventional rehabilitation
Sponsored by
IRCCS San Camillo, Venezia, Italy
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Stroke, Ischemic focused on measuring Muscle Synergies, MRI, Virtual Reality, Robotics

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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).

Sites / Locations

  • IRCCS Fondazione Don Gnocchi Onlus
  • IRCCS San Camillo, Venezia, Italy

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Technology-aided rehabilitation

Conventional rehabilitation

Arm Description

The technology-aided upper limb rehabilitation include reinforced feedback in virtual environment (RFVE), or robotic therapy.

The conventional upper limb rehabilitation program will be based on traditional rehabilitation techniques aimed at restoring upper limb motor functions.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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.
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.
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.
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.
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.
Box and Block Test
Measure of gross motor function of the hand and upper limb

Full Information

First Posted
May 8, 2018
Last Updated
June 7, 2022
Sponsor
IRCCS San Camillo, Venezia, Italy
Collaborators
Fondazione Don Carlo Gnocchi Onlus
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1. Study Identification

Unique Protocol Identification Number
NCT03530358
Brief Title
MOdularity for SEnsory Motor Control
Acronym
MOSE
Official Title
MOdularity for SEnsory Motor Control: Implications of Muscle Synergies in Motor Recovery After Stroke
Study Type
Interventional

2. Study Status

Record Verification Date
June 2022
Overall Recruitment Status
Active, not recruiting
Study Start Date
December 1, 2014 (Actual)
Primary Completion Date
December 1, 2018 (Actual)
Study Completion Date
December 1, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
IRCCS San Camillo, Venezia, Italy
Collaborators
Fondazione Don Carlo Gnocchi Onlus

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke, Ischemic, Upper Limb Injury, Rehabilitation
Keywords
Muscle Synergies, MRI, Virtual Reality, Robotics

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Randomized Clinical Trial
Masking
InvestigatorOutcomes Assessor
Masking Description
A simple random number sequence will be generated by a computer and the allocation concealment will be guaranteed using sequentially numbered, opaque sealed envelopes. The therapists responsible for randomization and allocation procedures will be independent of the blind therapists and medical doctors involved in patients' screening and treatment.
Allocation
Randomized
Enrollment
132 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Technology-aided rehabilitation
Arm Type
Experimental
Arm Description
The technology-aided upper limb rehabilitation include reinforced feedback in virtual environment (RFVE), or robotic therapy.
Arm Title
Conventional rehabilitation
Arm Type
Active Comparator
Arm Description
The conventional upper limb rehabilitation program will be based on traditional rehabilitation techniques aimed at restoring upper limb motor functions.
Intervention Type
Device
Intervention Name(s)
Technology-aided rehabilitation
Other Intervention Name(s)
Virtual Reality Rehabilitation System (VRRS), Braccio di Ferro
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Conventional rehabilitation
Intervention Description
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.
Primary Outcome Measure Information:
Title
Fugl-Meyer Assessment Scale - Upper Extremity (construct: upper limb motor function)
Description
Scale range scores: 0 - 66 points. Total summed score is reported with higher values representing a better outcome.
Time Frame
20 days
Secondary Outcome Measure Information:
Title
Functional Independence Measure (FIM) (construct: measure for independence in the activities of daily living - ADLs)
Description
Scale range scores: 18 - 126 points. Total summed score is reported with higher values representing a better outcome.
Time Frame
20 days
Title
Fugl-Meyer Assessment Scale - Range of Motion of Joints (construct: measure joints' passive range of motion)
Description
Scale range scores: 0 - 44 points. Total summed score is reported with higher values representing a better outcome.
Time Frame
20 days
Title
Fugl-Meyer Assessment Scale - Sensory Function (construct: measure of residual sensory function in upper and lower limbs affected by paresis)
Description
Scale range scores: 0 - 24 points. Total summed score is reported with higher values representing a better outcome.
Time Frame
20 days
Title
Fugl-Meyer Assessment Scale - Balance (construct: measure of impairment of standing and balance functions)
Description
Scale range scores: 0 - 14 points. Total summed score is reported with higher values representing a better outcome.
Time Frame
20 days
Title
Reaching Performance Scale (construct: measure of the ability to reach targets in the frontal space of upper limb affected by paresis)
Description
Scale range scores: 0 - 36 points. Total summed score is reported with higher values representing a better outcome.
Time Frame
20 days
Title
Modified Ashworth Scale (construct: measure of spasticity at the upper limb)
Description
Scale range scores: 0 - 5 ranks. Total summed ranks are reported with higher values representing a worse outcome.
Time Frame
20 days
Title
Box and Block Test
Description
Measure of gross motor function of the hand and upper limb
Time Frame
20 days
Other Pre-specified Outcome Measures:
Title
Mean duration [s]
Description
Time needed to execute standard motor tasks
Time Frame
20 days
Title
Mean velocity [cm/s]
Description
Velocity expressed to execute standard motor tasks
Time Frame
20 days
Title
Smoothness [number of submovements]
Description
Smoothness expressed to execute standard motor tasks
Time Frame
20 days
Title
Muscle synergies [n]
Description
Number of muscular patterns recognised by processing of surface electromyography data to execute standard motor tasks
Time Frame
20 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Andrea Turolla, PhD
Organizational Affiliation
IRCCS San Camillo, Venezia, Italy
Official's Role
Principal Investigator
Facility Information:
Facility Name
IRCCS Fondazione Don Gnocchi Onlus
City
Milan
Country
Italy
Facility Name
IRCCS San Camillo, Venezia, Italy
City
Venice
ZIP/Postal Code
30126
Country
Italy

12. IPD Sharing Statement

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MOdularity for SEnsory Motor Control

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