Rennes Chu
Rennes, 35000, France
Location status: Recruiting
NCT Number: NCT05884762
The aim of this study is to evaluate the effect of early rehabilitation treatment by electroencephalographic neurofeedback on upper limb motor function after stroke.
Researchers will compare :
Interventional group: electroencephalographic neurofeedback + traditional reference rehabilitation programme Control group: SHAM electroencephalographic neurofeedback + traditional reference rehabilitation programme
Interested in participating?
Request Info18 year–80 year
All sexes
Interventional
Not applicable
Rennes, 35000, France
Location status: Recruiting
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
The patient is installed in a quiet, isolated room in the Physical Medicine and Rehabilitation Department. The patient sits comfortably in front of a computer. A nurse or a rehabilitator installs the EEG headset and places gel in the electrodes (x32). Connecting the amplifier and interface. Checking the correct positioning and contact of the electrodes (impedance).
The patient is installed in a quiet, isolated room in the Physical Medicine and Rehabilitation Department. The patient sits comfortably in front of a computer. A nurse or a rehabilitator installs the EEG headset and places gel in the electrodes (x32). Connecting the amplifier and interface. Checking the correct positioning and contact of the electrodes (impedance).
Time frame: 28 days
Measurement of motor impairment by the Fugl-Meyer Assesment - Upper Extremity
Time frame: 28 days
Changes in ACTIVE RANGE OF MOTION (CxA) composite score
Time frame: 3 months
Changes in ACTIVE RANGE OF MOTION (CxA) composite score
Time frame: 28 days
Changes in Action Research Arm Test (ARAT) score
Time frame: 3 months
Changes in Action Research Arm Test (ARAT) score
Time frame: 28 days
Changes force emitted (in kg) during a palmar grip (JAMAR)
Time frame: 3 months
Changes force emitted (in kg) during a palmar grip (JAMAR)
Time frame: 28 days
Progression in Evaluation of the Motor activiy Log (MAL)
Time frame: 3 months
Progression in Evaluation of the Motor activiy Log (MAL)
Time frame: 28 days
Progression in The Composite Functional Independence Scale (MIF)
Time frame: 3 months
Progression in The Composite Functional Independence Scale (MIF)
Time frame: 28 days
Progression in The Stroke Impact Scale (SIS)
Time frame: 3 months
Progression in The Stroke Impact Scale (SIS)
Time frame: 28 days
Brain activity measured by electroencephalogram : improvement in cerebral activations in target zones
Time frame: 28 days
Brain datas (fMRI activity and CST tractography)
Time frame: 3 months
Assessing the a priori acceptance (acceptability) of overseeing neurofeedback protocol among healthcare professionals involved in the care of post-stroke patients, measured by semi-open interviews
Time frame: 3 months
Assessing the a priori acceptance (acceptability) of overseeing the neurofeedback protocol among healthcare professionals involved in the care of post-stroke patients, measured by questionnaires.
Time frame: 3 months
Assessing the retrospective adoption (acceptance) of overseeing the neurofeedback protocol among healthcare professionals involved in the care of post-stroke patients, measured by semi-open interviews
Time frame: 3 months
Assessing the retrospective adoption (acceptance) of overseeing the neurofeedback protocol among healthcare professionals involved in the care of post-stroke patients, measured by questionnaires.
Contact information is provided by the study sponsor or research team.
Rennes University Hospital
Other
Acronym: YUWIN-Stroke
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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