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

Not Applicable

Recruiting

• Conditions: Aphasia; Stroke

• Registration Number: NCT05776368
• Lead Sponsor: Hospices Civils de Lyon

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-03-08
• Study First Submitted QC: 2023-03-08
• Study First Posted: 2023-03-20
• Status Verified: 2023-05
• Study Start: 2023-05-26
• Last Update Submitted: 2023-05-31
• Last Update Posted: 2023-06-01
• Primary Completion: 2024-12-26
• Study Completion: 2024-12-26

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 360

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
reaction time	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	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.

Secondary Outcome Measures

Name	Time	Method
number of inserted pieces	4 weeks following the inclusion	The evolution of motor performance is represented by the number of inserted pieces during the nine training blocks of two minutes each.

Trial Locations

Locations (3)

Equipe ImpAct CRNL; 🇫🇷 Bron Cedex, France

Hôpital neurologique Pierre Wertheimer; 🇫🇷 Bron, France

Hôpital Henry Gabrielle; 🇫🇷 Saint-Genis-Laval, France