StrokeMOTOLANG-AVCNCT05776368
Links Between Motor Abilities and Language Ability Deficits in Patients With Post-stroke Aphasia
A study testing Syntactic comprehension battery (BCS), Montreal Cognitive Assessment (MOCA) and Purdue Pegboard Test in people with Stroke and Aphasia, run by Hospices Civils de Lyon at 3 sites in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- What is being tested?
- Syntactic comprehension battery (BCS), Montreal Cognitive Assessment (MOCA) and Purdue Pegboard Test
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 360 participants
- Where
- 3 sitesFrance
- Study dates
- 26 May 2023to 26 Dec 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Show all 10Show fewer
- 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)
Who cannot join
- 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).
Show all 10Show fewer
- 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
Trial locations and contacts
3 sites in 1 country.
Mallory AUGIER contact
France3 sites, 3 recruiting
- Recruiting
Equipe ImpAct CRNL
Bron, 69500
Claudio BROZZOLI, 04 72 95 34 10 ext. +33, claudio.brozzoli@inserm.fr
Mallory AUGIER, mallory.augier@gmail.com
- Recruiting
Hôpital neurologique Pierre Wertheimer
Bron, 69500
Jacques LUAUTÉ, Pr, 04 78 86 51 87 ext. +33, jacques.luaute@chu-lyon.fr
Jacques LUAUTÉ, Pr
- Recruiting
Hôpital Henry Gabrielle
Saint-Genis-Laval, 69230
Jacques LUAUTÉ, Pr, 04 78 86 51 87 ext. +33, jacques.luaute@chu-lyon.fr
Jacques LUAUTÉ
About this study
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.
Read more
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
- Being tested
- Syntactic comprehension battery (BCS), Montreal Cognitive Assessment (MOCA), Purdue Pegboard Test, The Box and Block Test (BBT), Motor training with a tool
- Keywords
- stroke, aphasia, rehabilitation, tool use, Broca's area, basal ganglia, healthy volunteer, language and motor abilities
- Medical subject headings
- Stroke, Aphasia, Language
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Syntactic comprehension battery (BCS)Other
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.
Montreal Cognitive Assessment (MOCA)Other
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.
Purdue Pegboard TestOther
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.
The Box and Block Test (BBT)Other
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.
Motor training with a toolOther
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)
Motor training with a handOther
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).
on/off effect of tool motor trainingOther
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.
linguistic tasksOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Sub-study E1, arm 1, patients and tool motor training | Experimental | patients undergo a 30 minutes tool motor training and two linguistic tasks (one before and one after). Receives: Other: Syntactic comprehension battery (BCS); Other: Montreal Cognitive Assessment (MOCA); Other: Purdue Pegboard Test; Other: The Box and Block Test (BBT); Other: Motor training with a tool; Other: linguistic tasks |
| Sub-study E1, arm 2, patients and hand motor training | Experimental | patients undergo a 30 minutes hand motor training and two linguistic tasks (one before and one after). Receives: Other: Syntactic comprehension battery (BCS); Other: Montreal Cognitive Assessment (MOCA); Other: Purdue Pegboard Test; Other: The Box and Block Test (BBT); Other: Motor training with a hand; Other: linguistic tasks |
| Sub-study E1, arm 3, patients and no motor training (control group) | Experimental | patients only undergo two linguistic tasks separated by a 30-minutes break (without motor activity (control group)). Receives: Other: Syntactic comprehension battery (BCS); Other: Montreal Cognitive Assessment (MOCA); Other: Purdue Pegboard Test; Other: The Box and Block Test (BBT); Other: linguistic tasks |
| Sub-study E1, arm 4, healthy volunteers and tool motor training | Experimental | healthy volunteers undergo a 30 minutes tool motor training and two linguistic tasks (one before and one after). Receives: Other: Syntactic comprehension battery (BCS); Other: Montreal Cognitive Assessment (MOCA); Other: Purdue Pegboard Test; Other: The Box and Block Test (BBT); Other: Motor training with a tool; Other: linguistic tasks |
| Sub-study E1, arm 5, healthy volunteers and hand motor training | Experimental | healthy volunteers undergo a 30 minutes hand motor training and two linguistic tasks (one before and one after). Receives: Other: Syntactic comprehension battery (BCS); Other: Montreal Cognitive Assessment (MOCA); Other: Purdue Pegboard Test; Other: The Box and Block Test (BBT); Other: Motor training with a hand; Other: linguistic tasks |
| Sub-study E1, arm 6, healthy volunteers and no motor training (control group) | Experimental | healthy volunteers only undergo two linguistic tasks separated by a 30-minutes break (without motor activity (control group)). Receives: Other: Syntactic comprehension battery (BCS); Other: Montreal Cognitive Assessment (MOCA); Other: Purdue Pegboard Test; Other: The Box and Block Test (BBT); Other: linguistic tasks |
| Sub-study E2, arm 1, single case design | Experimental | patients undergo 4 weeks of tool motor training according to an on/off design. Receives: Other: Syntactic comprehension battery (BCS); Other: Montreal Cognitive Assessment (MOCA); Other: Purdue Pegboard Test; Other: The Box and Block Test (BBT); Other: on/off effect of tool motor training; Other: linguistic tasks |
| Sub-study E3, arm 1, patients and 4 week experimental sensorimotor protocol | Experimental | patients undergo 4 weeks of tool motor training Receives: Other: Syntactic comprehension battery (BCS); Other: Montreal Cognitive Assessment (MOCA); Other: Purdue Pegboard Test; Other: The Box and Block Test (BBT); Other: Motor training with a tool; Other: linguistic tasks |
| Sub-study E3, arm 2, control group of patients | Experimental | aphasic patients receiving the standard treatment as a control group Receives: Other: Syntactic comprehension battery (BCS); Other: Montreal Cognitive Assessment (MOCA); Other: Purdue Pegboard Test; Other: The Box and Block Test (BBT); Other: linguistic tasks |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 4 weeks following the inclusion
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.
Measured: 4 weeks following the inclusion
Secondary outcomes (1)
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.
Measured: 4 weeks following the inclusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Mar 2023
- Study start26 May 2023
- Primary completion26 Dec 2024 (estimated)
- Study completion26 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for StrokeStudies of the same condition, open and under way.
- More trials run by Hospices Civils de LyonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 360 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospices Civils de Lyon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05776368
- Sponsor's protocol ID
- 69HCL22_0472
- Other IDs
- 2022-A01229-34
- Acronym
- MOTOLANG-AVC
- Status last verified
- May 2023
- First submitted
- 8 Mar 2023
- Last updated
- 1 Jun 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Links Between Motor Abilities and Language Ability Deficits in Patients With Post-stroke Aphasia
- ClinicalTrials.gov ID
- NCT05776368
- Acronym / sponsor ID
- MOTOLANG-AVC / 69HCL22_0472
- Keywords
- stroke, aphasia, rehabilitation, tool use, Broca's area, basal ganglia, healthy volunteer, language and motor abilities
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 360 participants (estimated)
- Lead sponsor
- Hospices Civils de LyonUniversity, hospital or other
- Study start
- 26 May 2023 (actual)
- Primary completion
- 26 Dec 2024 (estimated)
- Study completion
- 26 Dec 2024 (estimated)
- First posted
- 20 Mar 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 9
| Arm | Type | Receives |
|---|---|---|
| Sub-study E1, arm 1, patients and tool motor training | Experimental | Other: Syntactic comprehension battery (BCS), Other: Montreal Cognitive Assessment (MOCA), Other: Purdue Pegboard Test, Other: The Box and Block Test (BBT), Other: Motor training with a tool, Other: linguistic taskspatients undergo a 30 minutes tool motor training and two linguistic tasks (one before and one after). |
| Sub-study E1, arm 2, patients and hand motor training | Experimental | Other: Syntactic comprehension battery (BCS), Other: Montreal Cognitive Assessment (MOCA), Other: Purdue Pegboard Test, Other: The Box and Block Test (BBT), Other: Motor training with a hand, Other: linguistic taskspatients undergo a 30 minutes hand motor training and two linguistic tasks (one before and one after). |
| Sub-study E1, arm 3, patients and no motor training (control group) | Experimental | Other: Syntactic comprehension battery (BCS), Other: Montreal Cognitive Assessment (MOCA), Other: Purdue Pegboard Test, Other: The Box and Block Test (BBT), Other: linguistic taskspatients only undergo two linguistic tasks separated by a 30-minutes break (without motor activity (control group)). |
| Sub-study E1, arm 4, healthy volunteers and tool motor training | Experimental | Other: Syntactic comprehension battery (BCS), Other: Montreal Cognitive Assessment (MOCA), Other: Purdue Pegboard Test, Other: The Box and Block Test (BBT), Other: Motor training with a tool, Other: linguistic taskshealthy volunteers undergo a 30 minutes tool motor training and two linguistic tasks (one before and one after). |
| Sub-study E1, arm 5, healthy volunteers and hand motor training | Experimental | Other: Syntactic comprehension battery (BCS), Other: Montreal Cognitive Assessment (MOCA), Other: Purdue Pegboard Test, Other: The Box and Block Test (BBT), Other: Motor training with a hand, Other: linguistic taskshealthy volunteers undergo a 30 minutes hand motor training and two linguistic tasks (one before and one after). |
| Sub-study E1, arm 6, healthy volunteers and no motor training (control group) | Experimental | Other: Syntactic comprehension battery (BCS), Other: Montreal Cognitive Assessment (MOCA), Other: Purdue Pegboard Test, Other: The Box and Block Test (BBT), Other: linguistic taskshealthy volunteers only undergo two linguistic tasks separated by a 30-minutes break (without motor activity (control group)). |
| Sub-study E2, arm 1, single case design | Experimental | Other: Syntactic comprehension battery (BCS), Other: Montreal Cognitive Assessment (MOCA), Other: Purdue Pegboard Test, Other: The Box and Block Test (BBT), Other: on/off effect of tool motor training, Other: linguistic taskspatients undergo 4 weeks of tool motor training according to an on/off design. |
| Sub-study E3, arm 1, patients and 4 week experimental sensorimotor protocol | Experimental | Other: Syntactic comprehension battery (BCS), Other: Montreal Cognitive Assessment (MOCA), Other: Purdue Pegboard Test, Other: The Box and Block Test (BBT), Other: Motor training with a tool, Other: linguistic taskspatients undergo 4 weeks of tool motor training |
| Sub-study E3, arm 2, control group of patients | Experimental | Other: Syntactic comprehension battery (BCS), Other: Montreal Cognitive Assessment (MOCA), Other: Purdue Pegboard Test, Other: The Box and Block Test (BBT), Other: linguistic tasksaphasic patients receiving the standard treatment as a control group |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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
Key exclusion criteria (10 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Syntactic comprehension battery (BCS)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. | Other | 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 |
| Montreal Cognitive Assessment (MOCA)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. | Other | 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 |
| Purdue Pegboard TestThe 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. | Other | 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 |
| The Box and Block Test (BBT)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. | Other | 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 |
| Motor training with a toolThe 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) | Other | Sub-study E1, arm 1, patients and tool motor training, Sub-study E1, arm 4, healthy volunteers and tool motor training, Sub-study E3, arm 1, patients and 4 week experimental sensorimotor protocol |
| Motor training with a handThe 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). | Other | Sub-study E1, arm 2, patients and hand motor training, Sub-study E1, arm 5, healthy volunteers and hand motor training |
| on/off effect of tool motor trainingDuring 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. | Other | Sub-study E2, arm 1, single case design |
| linguistic tasksThe 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. | Other | 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 |
Primary outcome
reaction time
Time frame: 4 weeks following the inclusion
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
Time frame: 4 weeks following the inclusion
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.
1 secondary outcome
number of inserted pieces
Time frame: 4 weeks following the inclusion
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jun 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mallory AUGIER contact
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Syntactic comprehension battery (BCS), Montreal Cognitive Assessment (MOCA) and Purdue Pegboard Test in people with Stroke and Aphasia, run by Hospices Civils de Lyon at 3 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 1 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Claudio BROZZOLI (04 72 95 34 10 ext. +33, claudio.brozzoli@inserm.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
reaction time (time frame: 4 weeks following the inclusion). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Jun 2023.