Ignite Creation Date:
2024-05-06 @ 6:31 PM
Last Modification Date:
2024-10-26 @ 2:50 PM
Study NCT ID:
NCT05696925
Status:
NOT_YET_RECRUITING
Last Update Posted:
2023-01-25
First Post:
2022-10-18
Brief Title:
Effects of Motor Imagery and Action Observation on Upper Limb Motor Chances and Cognitive Chances in Parkinsons Disease
Sponsor:
Federal University of Health Science of Porto Alegre
Organization:
Federal University of Health Science of Porto Alegre
Study Overview
Official Title:
Effects of Motor Imagery and Action Observation on Upper Limb Motor Chances and Cognitive Chances in Parkinsons Disease Randomized Clinical Trial
Status:
NOT_YET_RECRUITING
Status Verified Date:
2023-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Parkinsons disease is degenerative progressive and chronic It is considered potentially disabling in view of the motor alterations such as bradykinesia rigidity and tremor in the upper limbs and non-motor alterations such as cognitive ones involving attention concentration and memory difficulties Thus neurorehabilitation modalities such as motor imagery and action observation have been used The aim of this research is to investigate the effects of motor imagery and action observation on upper limb motor and cognitive changes in Parkinsons disease This is a randomized controlled trial type study The population of the study involves people with Parkinsons disease in stages 1-3 on the Hoehn and Yahr scale aged 20 to 59 years who must be on stable medication have no cognitive impairment with risk of dementia be able to imagine motor activities and have upper limb motor impairment The study groups will be a motor imagery observation of action and motor execution b motor imagery and motor execution c observation of action and motor execution d motor imagery and motor execution and exoskeleton e observation of action and motor execution and exoskeleton The interventions of all groups will be an intensive approach of 10 continuous sessions with a two-day break in the middle of the intervention totaling two weeks with each session lasting 40 minutes a day The data collection steps for the study will involve the pre-test the interventions the immediate post-test and the test after a four-week period without intervention The instruments that will be used for the evaluations will be a part of the Unified Parkinsons Disease Rating Scale UPDRS-III b Test Dévaluation Des Membres Supérieurs Des Personnes Âgées TEMPA c 9-Hole Peg Test to assess upper extremity function d Parkinsons Disease Cognitive Assessment Scale e Canadian Occupational Performance Measure to identify performance and satisfaction in performing activities in the areas of self-care productivity and leisure
Detailed Description:
Parkinsons disease PD is degenerative occurs slowly and progressively is idiopathic and involves several factors In PD occurs the degeneration of dopamine-producing neurons dopaminergic neurons in the substantia nigra within the basal ganglia The activation of excitatory neurons then occurs manifesting itself through the dysregulation of motor control
PD is characterized by non-motor and motor symptoms being causes of negative implications in quality of life reflecting directly in several daily situations of the person with PD Non-motor symptoms are considered as additional symptoms and are also frequent having the prevalence of dementia and mild cognitive impairment The most observed cognitive problems in PD are in the following domains concentration and attention working memory as well as difficulties with calculations and spatial orientation activities and executive functions The non-motor symptoms have a negative impact on occupational performance and may present difficulties in activities such as driving shopping household maintenance as well as self-care dressing and bathing
The main motor symptoms are a resting tremor - occurs at rest and decreases when voluntary movement is attempted b rigidity - simultaneous increase in muscle tone which may present a constant resistance throughout the range of motion when the movement is slow and progressive or a rhythmically resisted movement throughout the range of motion c akinesia - difficulty to initiate movement d bradykinesia - slowness to maintain movement
The tremor in PD is an involuntary rhythmic movement typically characterized by unilateral resting tremor which occurs in the upper extremities especially the hands Resting tremor is inhibited during movement and may reappear as frequently when adopting a posture or even when moving The essential tremor occurs more in the forearms and hands being more problematic during voluntary movement or when maintaining the posture against gravity which affects the performance of activities of daily living and the most affected are writing by hand eating dressing and taking care of oneself There are also isolated postural and kinetic tremors with an even higher frequency greater than 4 Hz
In turn rigidity is one of the cardinal symptoms of PD and includes information on severity distribution and whether it is present at rest and in a non-drug state People with PD have higher rigidity values both at rest and during passive mobilization because there is an increased tone in the muscles Reduced range of motion can be a debilitating consequence of PD affecting daily activities such as writing Regarding bradykinesia it refers to the difficulty of adjusting body position initiating and executing movement and performing sequential and simultaneous movements
People with PD generally have difficulty initiating movements with slower movements and reduced range This reflects with the difficulty performing most daily activities personal care dressing work and leisure activities and household chores by the relationship with fine motor coordination and dexterity as well as bimanual coordination hypokinesis and initiation
Currently there is no approved treatment that changes the progression rate of PD and the possibilities are focused on the mitigation of symptoms since there is no known cure The degeneration of dopaminergic neurons triggers the changes in the basal ganglia network and is mainly treated with medication such as levodopa or dopaminergic antagonist being a dopamine replacement therapy which compensates for the lack of dopamine produced endogenously
Conventional rehabilitation associated with other intervention possibilities in addition physical exercise are important for the maintenance of motor and non-motor changes complementing the pharmacological treatment
Motor imagery MI and action observation AO are two innovative rehabilitation approaches that are feasible in various pathological conditions Thus there is an investment of applying both as a tool in neurorehabilitation and significant benefits can be induced in PD
From a systematic review of the 25 articles selected there was no record of a study involving the investigation of the joint action of MI and long-term AO and only one comparing the effect of both in a single session but the rest dealt with the effect of OA or MI isolated in a single session experiment or the effect of only OA or only MI as a long-term treatment Another relevant note is that the use of approaches in PD are more directed to motor symptoms in lower limbs such as balance and gait alterations
The combination of AO and MI increases imitation in PD being a promising therapeutic approach for helping people with PD in their activities of daily living and symptom management since the actions are presented in the context of daily lifeThus MI and AO used as therapeutic programs can improve motor skills by increasing proprioceptive signals normally generated during movements or slow down the deterioration of motor skills in PD
Motor imagery MI is a cognitive process that involves the ability to perform an action mentally without the need to perform the movement itself The perspective that the person uses to imagine can be internal perspective first person - imagines himselfherself which relates to the persons view of the content of the images or to hisher kinesthetic sensation - the person imagines the movement being performed as if feeling the movement of the action or external perspective third person - imagines another person which relates to the visual imagination of scenes outside the person
Like motor execution MI training can induce improvements in motor performance and therefore in the motor learning processes in PD Despite the few studies in PD there is evidence that mental practice can reduce bradykinesia improve mobility and gait speed as well as improve dynamic stability besides showing no tremor in the condition with medication during rest and mental task
Action observation consists of watching another person acting or doing a motor task on video or in real-time It is recognized that when observing another person acting there is brain activation in the same neural structures used for the real execution of the same actions being recruited in the brain of the observer as if performing the observed action
The AO shows everyday actions providing information for performing them in life contexts AO is an effective way to learn or improve the performance of a motor skill modifying the speed and accuracy of actions in PD The use of AO in PD improves the spontaneous rate of self-rhythmic finger movements which reflects in the improvement in the performance of activities of daily living
The term Brain-Machine Interface BMI refers to systems that capture the individuals brain activity signals translating them into computer commands to control external devices which can be communication devices functional electrical stimulation FES or robotic exoskeletons BMI technology is relatively new and it allows a person to interact with the environment through brain signals and can restore motor function by inducing brain plasticity
To capture these brain signals invasive and non-invasive strategies can be used In non-invasive systems electrodes are positioned on the skull cap using signals collected by electroencephalography EEG magnetoencephalography MEG and functional near-infrared spectroscopy fNIRS being more promising than invasive strategies due to safety and ethical issues
In typical BMI through EEG the persons movement intention motor imagery or execution is decoded in real-time through the ongoing brain electrical activity triggered by sensory feedback BMIs are currently used mainly in two applications in assistive technologies or movement paralysis and in rehabilitation technologies also called rehabilitative Brain-Machine Interface or neurofeedback that aims to promote neuroplasticity through manipulation or autoregulation of neurophysiological activity to facilitate motor recovery
Among numerous neurofunctional dysfunctions Parkinsons disease PD could benefit most from this technology The use of BMI through EEG with Functional Electrical Stimulation FES to stimulate the muscles of the upper limb during the execution phase of the AO when facing the execution of an observed motor act may present advantages such as improved performance whatever the severity of the neurological impairment such as severe PD The literature presents different BMI employed to people with PD and so far there is no study evaluating the training of motor imagery and observation of the action to improve the activity of the sensorimotor cortex with EEG associated with a robotic haptic glove
PD is characterized by non-motor and motor symptoms being causes of negative implications in quality of life reflecting directly in several daily situations of the person with PD Non-motor symptoms are considered as additional symptoms and are also frequent having the prevalence of dementia and mild cognitive impairment The most observed cognitive problems in PD are in the following domains concentration and attention working memory as well as difficulties with calculations and spatial orientation activities and executive functions The non-motor symptoms have a negative impact on occupational performance and may present difficulties in activities such as driving shopping household maintenance as well as self-care dressing and bathing
The main motor symptoms are a resting tremor - occurs at rest and decreases when voluntary movement is attempted b rigidity - simultaneous increase in muscle tone which may present a constant resistance throughout the range of motion when the movement is slow and progressive or a rhythmically resisted movement throughout the range of motion c akinesia - difficulty to initiate movement d bradykinesia - slowness to maintain movement
The tremor in PD is an involuntary rhythmic movement typically characterized by unilateral resting tremor which occurs in the upper extremities especially the hands Resting tremor is inhibited during movement and may reappear as frequently when adopting a posture or even when moving The essential tremor occurs more in the forearms and hands being more problematic during voluntary movement or when maintaining the posture against gravity which affects the performance of activities of daily living and the most affected are writing by hand eating dressing and taking care of oneself There are also isolated postural and kinetic tremors with an even higher frequency greater than 4 Hz
In turn rigidity is one of the cardinal symptoms of PD and includes information on severity distribution and whether it is present at rest and in a non-drug state People with PD have higher rigidity values both at rest and during passive mobilization because there is an increased tone in the muscles Reduced range of motion can be a debilitating consequence of PD affecting daily activities such as writing Regarding bradykinesia it refers to the difficulty of adjusting body position initiating and executing movement and performing sequential and simultaneous movements
People with PD generally have difficulty initiating movements with slower movements and reduced range This reflects with the difficulty performing most daily activities personal care dressing work and leisure activities and household chores by the relationship with fine motor coordination and dexterity as well as bimanual coordination hypokinesis and initiation
Currently there is no approved treatment that changes the progression rate of PD and the possibilities are focused on the mitigation of symptoms since there is no known cure The degeneration of dopaminergic neurons triggers the changes in the basal ganglia network and is mainly treated with medication such as levodopa or dopaminergic antagonist being a dopamine replacement therapy which compensates for the lack of dopamine produced endogenously
Conventional rehabilitation associated with other intervention possibilities in addition physical exercise are important for the maintenance of motor and non-motor changes complementing the pharmacological treatment
Motor imagery MI and action observation AO are two innovative rehabilitation approaches that are feasible in various pathological conditions Thus there is an investment of applying both as a tool in neurorehabilitation and significant benefits can be induced in PD
From a systematic review of the 25 articles selected there was no record of a study involving the investigation of the joint action of MI and long-term AO and only one comparing the effect of both in a single session but the rest dealt with the effect of OA or MI isolated in a single session experiment or the effect of only OA or only MI as a long-term treatment Another relevant note is that the use of approaches in PD are more directed to motor symptoms in lower limbs such as balance and gait alterations
The combination of AO and MI increases imitation in PD being a promising therapeutic approach for helping people with PD in their activities of daily living and symptom management since the actions are presented in the context of daily lifeThus MI and AO used as therapeutic programs can improve motor skills by increasing proprioceptive signals normally generated during movements or slow down the deterioration of motor skills in PD
Motor imagery MI is a cognitive process that involves the ability to perform an action mentally without the need to perform the movement itself The perspective that the person uses to imagine can be internal perspective first person - imagines himselfherself which relates to the persons view of the content of the images or to hisher kinesthetic sensation - the person imagines the movement being performed as if feeling the movement of the action or external perspective third person - imagines another person which relates to the visual imagination of scenes outside the person
Like motor execution MI training can induce improvements in motor performance and therefore in the motor learning processes in PD Despite the few studies in PD there is evidence that mental practice can reduce bradykinesia improve mobility and gait speed as well as improve dynamic stability besides showing no tremor in the condition with medication during rest and mental task
Action observation consists of watching another person acting or doing a motor task on video or in real-time It is recognized that when observing another person acting there is brain activation in the same neural structures used for the real execution of the same actions being recruited in the brain of the observer as if performing the observed action
The AO shows everyday actions providing information for performing them in life contexts AO is an effective way to learn or improve the performance of a motor skill modifying the speed and accuracy of actions in PD The use of AO in PD improves the spontaneous rate of self-rhythmic finger movements which reflects in the improvement in the performance of activities of daily living
The term Brain-Machine Interface BMI refers to systems that capture the individuals brain activity signals translating them into computer commands to control external devices which can be communication devices functional electrical stimulation FES or robotic exoskeletons BMI technology is relatively new and it allows a person to interact with the environment through brain signals and can restore motor function by inducing brain plasticity
To capture these brain signals invasive and non-invasive strategies can be used In non-invasive systems electrodes are positioned on the skull cap using signals collected by electroencephalography EEG magnetoencephalography MEG and functional near-infrared spectroscopy fNIRS being more promising than invasive strategies due to safety and ethical issues
In typical BMI through EEG the persons movement intention motor imagery or execution is decoded in real-time through the ongoing brain electrical activity triggered by sensory feedback BMIs are currently used mainly in two applications in assistive technologies or movement paralysis and in rehabilitation technologies also called rehabilitative Brain-Machine Interface or neurofeedback that aims to promote neuroplasticity through manipulation or autoregulation of neurophysiological activity to facilitate motor recovery
Among numerous neurofunctional dysfunctions Parkinsons disease PD could benefit most from this technology The use of BMI through EEG with Functional Electrical Stimulation FES to stimulate the muscles of the upper limb during the execution phase of the AO when facing the execution of an observed motor act may present advantages such as improved performance whatever the severity of the neurological impairment such as severe PD The literature presents different BMI employed to people with PD and so far there is no study evaluating the training of motor imagery and observation of the action to improve the activity of the sensorimotor cortex with EEG associated with a robotic haptic glove
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None