search
Back to results

Links Between Motor Abilities and Language Ability Deficits in Patients With Post-stroke Aphasia (MOTOLANG-AVC)

Primary Purpose

Stroke, Aphasia

Status
Recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Syntactic comprehension battery (BCS)
Montreal Cognitive Assessment (MOCA)
Purdue Pegboard Test
The Box and Block Test (BBT)
Motor training with a tool
Motor training with a hand
on/off effect of tool motor training
linguistic tasks
Sponsored by
Hospices Civils de Lyon
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Stroke focused on measuring stroke, aphasia, rehabilitation, tool use, Broca's area, basal ganglia, healthy volunteer, language and motor abilities

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria: For all participants: Adult male or female aged 18 years and over Right-handed Having signed an informed and written consent Affiliated to a social security scheme Have French as their first language For patients : Left inferior frontal gyrus lesion following a stroke Stroke more than 3 months old Aphasia proven by a pathological score on the A-2 test of the Syntax Comprehension Battery (BCS) Exclusion Criteria: For all participants: Cognitive abilities that prevent completion of the study tasks (assessed with the MOntreal Cognitive Assesment (MOCA)) Language skills impaired by other disorders (for example neurodegenerative disease) Cognitive impairing treatments (for example psychotropic drugs) Neurovisual disorder (hemineglect, unilateral spatial neglect) Impairment of both upper limb abilities that prevent motor training (pathological score in the Purdue Pegboard Test and/or Box and Block Test). Recurrence of a stroke impacting the reorganisation of neural networks Persons deprived of their liberty by a judicial or administrative decision Persons of legal age under a legal protection measure (guardianship, curatorship) Pregnant women, women in labour or nursing mothers, confirmed by questioning the participant Participation in another study at the same time as this one

Sites / Locations

  • Equipe ImpAct CRNLRecruiting
  • Hôpital neurologique Pierre WertheimerRecruiting
  • Hôpital Henry GabrielleRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm 7

Arm 8

Arm 9

Arm Type

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Arm Label

Sub-study E1, arm 1, patients and tool motor training

Sub-study E1, arm 2, patients and hand motor training

Sub-study E1, arm 3, patients and no motor training (control group)

Sub-study E1, arm 4, healthy volunteers and tool motor training

Sub-study E1, arm 5, healthy volunteers and hand motor training

Sub-study E1, arm 6, healthy volunteers and no motor training (control group)

Sub-study E2, arm 1, single case design

Sub-study E3, arm 1, patients and 4 week experimental sensorimotor protocol

Sub-study E3, arm 2, control group of patients

Arm Description

patients undergo a 30 minutes tool motor training and two linguistic tasks (one before and one after).

patients undergo a 30 minutes hand motor training and two linguistic tasks (one before and one after).

patients only undergo two linguistic tasks separated by a 30-minutes break (without motor activity (control group)).

healthy volunteers undergo a 30 minutes tool motor training and two linguistic tasks (one before and one after).

healthy volunteers undergo a 30 minutes hand motor training and two linguistic tasks (one before and one after).

healthy volunteers only undergo two linguistic tasks separated by a 30-minutes break (without motor activity (control group)).

patients undergo 4 weeks of tool motor training according to an on/off design.

patients undergo 4 weeks of tool motor training

aphasic patients receiving the standard treatment as a control group

Outcomes

Primary Outcome Measures

reaction time
This is defined as the time necessary to give a correct answer to the affirmation test. It is calculated at each trial of the syntactic task as the time between the appearance of the affirmation test and the time when a correct answer is provided by the patient. The unit of measure is millisecond. An average is then calculated for each condition (i.e. for each sentence type), at each time point.
sensitivity index
The sensitivity index is a measure of the accuracy of response which also takes into account the false alarms. It gives a measure of how the patient can distinguish the signal (correct syntax) from noise (incorrect syntax). It is calculated as the difference between the standardized proportion of correct responses (answer " True " correct) and the standardized proportion of fall alarms (answer " True " incorrect). It is expressed in zed points.

Secondary Outcome Measures

number of inserted pieces
The evolution of motor performance is represented by the number of inserted pieces during the nine training blocks of two minutes each.

Full Information

First Posted
March 8, 2023
Last Updated
May 31, 2023
Sponsor
Hospices Civils de Lyon
search

1. Study Identification

Unique Protocol Identification Number
NCT05776368
Brief Title
Links Between Motor Abilities and Language Ability Deficits in Patients With Post-stroke Aphasia
Acronym
MOTOLANG-AVC
Official Title
Links Between Motor Abilities and Language Ability Deficits in Patients With Post-stroke Aphasia
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Recruiting
Study Start Date
May 26, 2023 (Actual)
Primary Completion Date
December 26, 2024 (Anticipated)
Study Completion Date
December 26, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hospices Civils de Lyon

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
Aphasia is a language disorder that affects oral and written expression and/or comprehension. It's one of the most disabling consequence of stroke. Nowadays, aphasia rehabilitation is supported by speech therapists and is based on oral and written language, comprehension and expression. However recent studies have shown links between language and motor function (especially tool use). Two domains that share neural substrates (Broca's area, basal ganglia) and that can influence each other. The aim of this study is to show that a motor training with a tool (pliers) can improve short-term and long-term language abilities of aphasic patients who had a stroke at least 3 months ago. The investigators hypothesis is that there is a learning transfer between tool use and language abilities in aphasic patients with an inferior frontal gyrus (IFG) lesion caused by a stroke, thanks to their shared neural resources. Investigators aim to study long and short-time effects of this tool motor training with three experiments: E1 will study short-term effects by estimating pre-post effect of a motor training on language abilities. Investigators will experiment different effectors: tool, hand, none (control group); on patients and healthy volunteers. E2 will study long-term effects with multiple single-case experimental designs (SCED). Patients will undergo four weeks of on-off design. E3 will study long-term effects by estimating the efficiency of an experimental sensorimotor protocol of four weeks, comparing a group of patients with the experimental sensorimotor protocol to a control group of patients

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke, Aphasia
Keywords
stroke, aphasia, rehabilitation, tool use, Broca's area, basal ganglia, healthy volunteer, language and motor abilities

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
360 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Sub-study E1, arm 1, patients and tool motor training
Arm Type
Experimental
Arm Description
patients undergo a 30 minutes tool motor training and two linguistic tasks (one before and one after).
Arm Title
Sub-study E1, arm 2, patients and hand motor training
Arm Type
Experimental
Arm Description
patients undergo a 30 minutes hand motor training and two linguistic tasks (one before and one after).
Arm Title
Sub-study E1, arm 3, patients and no motor training (control group)
Arm Type
Experimental
Arm Description
patients only undergo two linguistic tasks separated by a 30-minutes break (without motor activity (control group)).
Arm Title
Sub-study E1, arm 4, healthy volunteers and tool motor training
Arm Type
Experimental
Arm Description
healthy volunteers undergo a 30 minutes tool motor training and two linguistic tasks (one before and one after).
Arm Title
Sub-study E1, arm 5, healthy volunteers and hand motor training
Arm Type
Experimental
Arm Description
healthy volunteers undergo a 30 minutes hand motor training and two linguistic tasks (one before and one after).
Arm Title
Sub-study E1, arm 6, healthy volunteers and no motor training (control group)
Arm Type
Experimental
Arm Description
healthy volunteers only undergo two linguistic tasks separated by a 30-minutes break (without motor activity (control group)).
Arm Title
Sub-study E2, arm 1, single case design
Arm Type
Experimental
Arm Description
patients undergo 4 weeks of tool motor training according to an on/off design.
Arm Title
Sub-study E3, arm 1, patients and 4 week experimental sensorimotor protocol
Arm Type
Experimental
Arm Description
patients undergo 4 weeks of tool motor training
Arm Title
Sub-study E3, arm 2, control group of patients
Arm Type
Experimental
Arm Description
aphasic patients receiving the standard treatment as a control group
Intervention Type
Other
Intervention Name(s)
Syntactic comprehension battery (BCS)
Intervention Description
The BCS is a battery for assessing syntactic skills. In this study, only one part of the BCS will be performed, namely task C2. It consists in assessing the ability to assign thematic roles. To do this, the participant selects the image corresponding to the sentence he/she hears on a board of 2 images. Task C2 consists of 50 tests of 2 images. A total score is given out of 50 points. The higher the score, the more successful the test.
Intervention Type
Other
Intervention Name(s)
Montreal Cognitive Assessment (MOCA)
Intervention Description
The MOCA is a short 30-question test that assesses several cognitive domains and allows for early detection of cognitive disorders. The MOCA test takes about 10-15 minutes to administer and consists of several sections, the first of which is an assessment of orientation in time and space. Then there are tasks that assess memory, concentration and reasoning ability, as well as language and visuospatial ability tasks. The MOCA score can range from 0 to 30 points, with a score of 26 points or more considered normal.
Intervention Type
Other
Intervention Name(s)
Purdue Pegboard Test
Intervention Description
The Purdue Pegboard Test is a test of fine motor skills and hand-eye coordination. The test consists of a perforated board with holes into which participants must insert pegs or counters. The assessment consists of four subtests, each repeated 3 times: Right hand (30 seconds): The total number of pins placed in the right column with the right hand in 30 seconds. Left hand (30 seconds): The total number of rods placed in the left column with the left hand in 30 seconds. Two hands (30 seconds): The total number of pairs of rods placed in both columns using both hands simultaneously, in 30 seconds. Assembly (60 seconds): The total number of rods, washers and clamps assembled in the allotted time, using both hands.
Intervention Type
Other
Intervention Name(s)
The Box and Block Test (BBT)
Intervention Description
The Box and Block Test (BBT) is a standardised test of manual dexterity used to assess motor function and hand-eye coordination in people of all ages. The subject must move, one by one, a maximum number of cubes from one compartment of the box to another of equal size for 60 seconds. He starts with the healthy upper limb or, if not, with the dominant side. A 15 second trial period is allowed at the beginning of each side.
Intervention Type
Other
Intervention Name(s)
Motor training with a tool
Intervention Description
The patient will do around 30 minutes of motor training with a tool (pliers). They have to put most pieces as possible in the board with the pliers. Patients hold the pliers with the right hand (dominant hand) or with the left one if not possible (motor disorder). For E1 Arm1 and E1 Arm 4: the participant will do the motor training with a tool one time in this study. For E3 Arm 1: the participant will do the motor training with a tool During 4 weeks (3 to 5 training sessions of 30 minutes)
Intervention Type
Other
Intervention Name(s)
Motor training with a hand
Intervention Description
The patient will do around 30 minutes of motor training with the hand. They have to put most pieces as possible in the board with the right hand (dominant hand) or with the left one if not possible (motor disorder).
Intervention Type
Other
Intervention Name(s)
on/off effect of tool motor training
Intervention Description
During 4 weeks, patients switch between tool training weeks ("on") and control weeks ("off") during which they don't practice motor training. During "on" weeks they do 3 to 5 tool motor training sessions of 30 minutes. They use pliers with the right hand (dominant hand) or with the left one if not possible (motor disorder) and have to put most pieces as possible in the board. During "off" weeks they do 3 to 5 control sessions where they only do the two linguistic tasks separated between a 30-minutes break.
Intervention Type
Other
Intervention Name(s)
linguistic tasks
Intervention Description
The linguistic tasks consists in the presentation of correct sentences at the center of a computer screen. The sentence can be a coordinated one (" The policeman stopped the woman and asked the question "), or a subject relative (i.e., " The policeman who stopped the woman asked the question "), or an object relative (" The policeman who the woman stopped asked the question "). After the sentence an affirmation test is proposed of the kind " the policeman stopped the woman ", and the participant has to respond ads quick as possible whether it is true or false.
Primary Outcome Measure Information:
Title
reaction time
Description
This is defined as the time necessary to give a correct answer to the affirmation test. It is calculated at each trial of the syntactic task as the time between the appearance of the affirmation test and the time when a correct answer is provided by the patient. The unit of measure is millisecond. An average is then calculated for each condition (i.e. for each sentence type), at each time point.
Time Frame
4 weeks following the inclusion
Title
sensitivity index
Description
The sensitivity index is a measure of the accuracy of response which also takes into account the false alarms. It gives a measure of how the patient can distinguish the signal (correct syntax) from noise (incorrect syntax). It is calculated as the difference between the standardized proportion of correct responses (answer " True " correct) and the standardized proportion of fall alarms (answer " True " incorrect). It is expressed in zed points.
Time Frame
4 weeks following the inclusion
Secondary Outcome Measure Information:
Title
number of inserted pieces
Description
The evolution of motor performance is represented by the number of inserted pieces during the nine training blocks of two minutes each.
Time Frame
4 weeks following the inclusion

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: For all participants: Adult male or female aged 18 years and over Right-handed Having signed an informed and written consent Affiliated to a social security scheme Have French as their first language For patients : Left inferior frontal gyrus lesion following a stroke Stroke more than 3 months old Aphasia proven by a pathological score on the A-2 test of the Syntax Comprehension Battery (BCS) Exclusion Criteria: For all participants: Cognitive abilities that prevent completion of the study tasks (assessed with the MOntreal Cognitive Assesment (MOCA)) Language skills impaired by other disorders (for example neurodegenerative disease) Cognitive impairing treatments (for example psychotropic drugs) Neurovisual disorder (hemineglect, unilateral spatial neglect) Impairment of both upper limb abilities that prevent motor training (pathological score in the Purdue Pegboard Test and/or Box and Block Test). Recurrence of a stroke impacting the reorganisation of neural networks Persons deprived of their liberty by a judicial or administrative decision Persons of legal age under a legal protection measure (guardianship, curatorship) Pregnant women, women in labour or nursing mothers, confirmed by questioning the participant Participation in another study at the same time as this one
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Claudio BROZZOLI
Phone
04 72 95 34 10
Ext
+33
Email
claudio.brozzoli@inserm.fr
First Name & Middle Initial & Last Name or Official Title & Degree
Mallory AUGIER
Email
mallory.augier@gmail.com
Facility Information:
Facility Name
Equipe ImpAct CRNL
City
Bron Cedex
ZIP/Postal Code
69500
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Claudio BROZZOLI
Phone
04 72 95 34 10
Ext
+33
Email
claudio.brozzoli@inserm.fr
First Name & Middle Initial & Last Name & Degree
Mallory AUGIER
Email
mallory.augier@gmail.com
First Name & Middle Initial & Last Name & Degree
Claudio BROZZOLI
Facility Name
Hôpital neurologique Pierre Wertheimer
City
Bron
ZIP/Postal Code
69500
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jacques LUAUTÉ, Pr
Phone
04 78 86 51 87
Ext
+33
Email
jacques.luaute@chu-lyon.fr
First Name & Middle Initial & Last Name & Degree
Jacques LUAUTÉ, Pr
First Name & Middle Initial & Last Name & Degree
Tae-Hee CHO, Pr
Facility Name
Hôpital Henry Gabrielle
City
Saint-Genis-Laval
ZIP/Postal Code
69230
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jacques LUAUTÉ, Pr
Phone
04 78 86 51 87
Ext
+33
Email
jacques.luaute@chu-lyon.fr
First Name & Middle Initial & Last Name & Degree
Jacques LUAUTÉ

12. IPD Sharing Statement

Learn more about this trial

Links Between Motor Abilities and Language Ability Deficits in Patients With Post-stroke Aphasia

We'll reach out to this number within 24 hrs