Links Between Motor Abilities and Language Ability Deficits in Patients With Post-stroke Aphasia
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 360
- 试验地点
- 3
- 主要终点
- reaction time
研究概览
简要总结
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
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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)
排除标准
- •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
研究组 & 干预措施
Sub-study E1, arm 1, patients and tool motor training
patients undergo a 30 minutes tool motor training and two linguistic tasks (one before and one after).
干预措施: Purdue Pegboard Test (Other)
Sub-study E1, arm 1, patients and tool motor training
patients undergo a 30 minutes tool motor training and two linguistic tasks (one before and one after).
干预措施: Syntactic comprehension battery (BCS) (Other)
Sub-study E1, arm 1, patients and tool motor training
patients undergo a 30 minutes tool motor training and two linguistic tasks (one before and one after).
干预措施: Montreal Cognitive Assessment (MOCA) (Other)
Sub-study E1, arm 1, patients and tool motor training
patients undergo a 30 minutes tool motor training and two linguistic tasks (one before and one after).
干预措施: The Box and Block Test (BBT) (Other)
Sub-study E1, arm 1, patients and tool motor training
patients undergo a 30 minutes tool motor training and two linguistic tasks (one before and one after).
干预措施: Motor training with a tool (Other)
Sub-study E1, arm 1, patients and tool motor training
patients undergo a 30 minutes tool motor training and two linguistic tasks (one before and one after).
干预措施: linguistic tasks (Other)
Sub-study E1, arm 2, patients and hand motor training
patients undergo a 30 minutes hand motor training and two linguistic tasks (one before and one after).
干预措施: Purdue Pegboard Test (Other)
Sub-study E1, arm 2, patients and hand motor training
patients undergo a 30 minutes hand motor training and two linguistic tasks (one before and one after).
干预措施: Syntactic comprehension battery (BCS) (Other)
Sub-study E1, arm 2, patients and hand motor training
patients undergo a 30 minutes hand motor training and two linguistic tasks (one before and one after).
干预措施: Montreal Cognitive Assessment (MOCA) (Other)
Sub-study E1, arm 2, patients and hand motor training
patients undergo a 30 minutes hand motor training and two linguistic tasks (one before and one after).
干预措施: The Box and Block Test (BBT) (Other)
Sub-study E1, arm 2, patients and hand motor training
patients undergo a 30 minutes hand motor training and two linguistic tasks (one before and one after).
干预措施: Motor training with a hand (Other)
Sub-study E1, arm 2, patients and hand motor training
patients undergo a 30 minutes hand motor training and two linguistic tasks (one before and one after).
干预措施: linguistic tasks (Other)
Sub-study E1, arm 3, patients and no motor training (control group)
patients only undergo two linguistic tasks separated by a 30-minutes break (without motor activity (control group)).
干预措施: Purdue Pegboard Test (Other)
Sub-study E1, arm 3, patients and no motor training (control group)
patients only undergo two linguistic tasks separated by a 30-minutes break (without motor activity (control group)).
干预措施: Syntactic comprehension battery (BCS) (Other)
Sub-study E1, arm 3, patients and no motor training (control group)
patients only undergo two linguistic tasks separated by a 30-minutes break (without motor activity (control group)).
干预措施: Montreal Cognitive Assessment (MOCA) (Other)
Sub-study E1, arm 3, patients and no motor training (control group)
patients only undergo two linguistic tasks separated by a 30-minutes break (without motor activity (control group)).
干预措施: The Box and Block Test (BBT) (Other)
Sub-study E1, arm 3, patients and no motor training (control group)
patients only undergo two linguistic tasks separated by a 30-minutes break (without motor activity (control group)).
干预措施: linguistic tasks (Other)
Sub-study E1, arm 4, healthy volunteers and tool motor training
healthy volunteers undergo a 30 minutes tool motor training and two linguistic tasks (one before and one after).
干预措施: Syntactic comprehension battery (BCS) (Other)
Sub-study E1, arm 4, healthy volunteers and tool motor training
healthy volunteers undergo a 30 minutes tool motor training and two linguistic tasks (one before and one after).
干预措施: Montreal Cognitive Assessment (MOCA) (Other)
Sub-study E1, arm 4, healthy volunteers and tool motor training
healthy volunteers undergo a 30 minutes tool motor training and two linguistic tasks (one before and one after).
干预措施: Purdue Pegboard Test (Other)
Sub-study E1, arm 4, healthy volunteers and tool motor training
healthy volunteers undergo a 30 minutes tool motor training and two linguistic tasks (one before and one after).
干预措施: The Box and Block Test (BBT) (Other)
Sub-study E1, arm 4, healthy volunteers and tool motor training
healthy volunteers undergo a 30 minutes tool motor training and two linguistic tasks (one before and one after).
干预措施: Motor training with a tool (Other)
Sub-study E1, arm 4, healthy volunteers and tool motor training
healthy volunteers undergo a 30 minutes tool motor training and two linguistic tasks (one before and one after).
干预措施: linguistic tasks (Other)
Sub-study E1, arm 5, healthy volunteers and hand motor training
healthy volunteers undergo a 30 minutes hand motor training and two linguistic tasks (one before and one after).
干预措施: Purdue Pegboard Test (Other)
Sub-study E1, arm 5, healthy volunteers and hand motor training
healthy volunteers undergo a 30 minutes hand motor training and two linguistic tasks (one before and one after).
干预措施: Syntactic comprehension battery (BCS) (Other)
Sub-study E1, arm 5, healthy volunteers and hand motor training
healthy volunteers undergo a 30 minutes hand motor training and two linguistic tasks (one before and one after).
干预措施: Montreal Cognitive Assessment (MOCA) (Other)
Sub-study E1, arm 5, healthy volunteers and hand motor training
healthy volunteers undergo a 30 minutes hand motor training and two linguistic tasks (one before and one after).
干预措施: The Box and Block Test (BBT) (Other)
Sub-study E1, arm 5, healthy volunteers and hand motor training
healthy volunteers undergo a 30 minutes hand motor training and two linguistic tasks (one before and one after).
干预措施: Motor training with a hand (Other)
Sub-study E1, arm 5, healthy volunteers and hand motor training
healthy volunteers undergo a 30 minutes hand motor training and two linguistic tasks (one before and one after).
干预措施: linguistic tasks (Other)
Sub-study E1, arm 6, healthy volunteers and no motor training (control group)
healthy volunteers only undergo two linguistic tasks separated by a 30-minutes break (without motor activity (control group)).
干预措施: Purdue Pegboard Test (Other)
Sub-study E1, arm 6, healthy volunteers and no motor training (control group)
healthy volunteers only undergo two linguistic tasks separated by a 30-minutes break (without motor activity (control group)).
干预措施: Syntactic comprehension battery (BCS) (Other)
Sub-study E1, arm 6, healthy volunteers and no motor training (control group)
healthy volunteers only undergo two linguistic tasks separated by a 30-minutes break (without motor activity (control group)).
干预措施: Montreal Cognitive Assessment (MOCA) (Other)
Sub-study E1, arm 6, healthy volunteers and no motor training (control group)
healthy volunteers only undergo two linguistic tasks separated by a 30-minutes break (without motor activity (control group)).
干预措施: The Box and Block Test (BBT) (Other)
Sub-study E1, arm 6, healthy volunteers and no motor training (control group)
healthy volunteers only undergo two linguistic tasks separated by a 30-minutes break (without motor activity (control group)).
干预措施: linguistic tasks (Other)
Sub-study E2, arm 1, single case design
patients undergo 4 weeks of tool motor training according to an on/off design.
干预措施: Syntactic comprehension battery (BCS) (Other)
Sub-study E2, arm 1, single case design
patients undergo 4 weeks of tool motor training according to an on/off design.
干预措施: Montreal Cognitive Assessment (MOCA) (Other)
Sub-study E2, arm 1, single case design
patients undergo 4 weeks of tool motor training according to an on/off design.
干预措施: Purdue Pegboard Test (Other)
Sub-study E2, arm 1, single case design
patients undergo 4 weeks of tool motor training according to an on/off design.
干预措施: The Box and Block Test (BBT) (Other)
Sub-study E2, arm 1, single case design
patients undergo 4 weeks of tool motor training according to an on/off design.
干预措施: on/off effect of tool motor training (Other)
Sub-study E2, arm 1, single case design
patients undergo 4 weeks of tool motor training according to an on/off design.
干预措施: linguistic tasks (Other)
Sub-study E3, arm 1, patients and 4 week experimental sensorimotor protocol
patients undergo 4 weeks of tool motor training
干预措施: Purdue Pegboard Test (Other)
Sub-study E3, arm 1, patients and 4 week experimental sensorimotor protocol
patients undergo 4 weeks of tool motor training
干预措施: Syntactic comprehension battery (BCS) (Other)
Sub-study E3, arm 1, patients and 4 week experimental sensorimotor protocol
patients undergo 4 weeks of tool motor training
干预措施: Montreal Cognitive Assessment (MOCA) (Other)
Sub-study E3, arm 1, patients and 4 week experimental sensorimotor protocol
patients undergo 4 weeks of tool motor training
干预措施: The Box and Block Test (BBT) (Other)
Sub-study E3, arm 1, patients and 4 week experimental sensorimotor protocol
patients undergo 4 weeks of tool motor training
干预措施: Motor training with a tool (Other)
Sub-study E3, arm 1, patients and 4 week experimental sensorimotor protocol
patients undergo 4 weeks of tool motor training
干预措施: linguistic tasks (Other)
Sub-study E3, arm 2, control group of patients
aphasic patients receiving the standard treatment as a control group
干预措施: Purdue Pegboard Test (Other)
Sub-study E3, arm 2, control group of patients
aphasic patients receiving the standard treatment as a control group
干预措施: Syntactic comprehension battery (BCS) (Other)
Sub-study E3, arm 2, control group of patients
aphasic patients receiving the standard treatment as a control group
干预措施: Montreal Cognitive Assessment (MOCA) (Other)
Sub-study E3, arm 2, control group of patients
aphasic patients receiving the standard treatment as a control group
干预措施: The Box and Block Test (BBT) (Other)
Sub-study E3, arm 2, control group of patients
aphasic patients receiving the standard treatment as a control group
干预措施: linguistic tasks (Other)
结局指标
主要结局
reaction time
时间窗: 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
时间窗: 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.
次要结局
- number of inserted pieces(4 weeks following the inclusion)