Ignite Creation Date:
2024-10-25 @ 7:56 PM
Last Modification Date:
2024-10-26 @ 3:43 PM
Study NCT ID:
NCT06648187
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-10-13
Brief Title:
Early Motor-Cognitive Integrative Training on Cognitive and Motor Performance in Aneurysmal Subarachnoid Hemorrhage
Sponsor:
None
Organization:
None
Study Overview
Official Title:
The Efficacy of Early Motor-Cognitive Integrative Training on Cognitive and Motor Performance in Patients With Aneurysmal Subarachnoid Hemorrhage A Pilot Study
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Despite its lower incidence rate within the stroke population and tendency to affect younger individuals SAH carries the highest risk of PSCI The neural mechanisms underlying these cognitive deficits remain poorly understood but potential factors include treatment approaches underlying disease pathophysiology post-disease complications or alterations in neural connectivity Previous literature indicates that cognitive deficits in SAH primarily manifest in areas such as visuospatial skill verbal memory language abilities including verbal comprehension verbal fluency abstract language executive function working memory and attention These impairments significantly impact patients ability to perform ADL independently and return to work despite motor function recovery This pilot study tests the feasibility logistics and methodology of the research project as well as to identify any potential problems or challenges that may arise In the future the investigators plan to examine the impact of early intervention with MCIT e-MCIT on cognitive function motor recovery functional abilities and ADL in acute SAH patients upon discharge from the ICU and during the post-intervention assessment The hypothesis of this study is that there is feasibility and safety in early intervention with MCIT e-MCIT in aSAH patients Otherwise e-MCIT will result in significant improvements in cognitive function motor recovery functional abilities and ADL among SAH patients upon discharge from the ICU and the post-intervention assessment in future work will identify by comparing with early mobilization group only
Detailed Description:
Background and literature review Spontaneous subarachnoid hemorrhage SAH often resulting from intracerebral aneurysm rupture is a relatively uncommon but impactful form of stroke predominantly affecting middle-aged individuals Aneurysmal SAH aSAH presents a high risk of post-stroke cognitive impairment PSCI compared to other stroke types with an occurrence rate ranging from 26 to 43 Cognitive impairments particularly in executive function attention memory and language abilities are prevalent among aSAH survivors with notable differences observed in cognitive outcomes based on medical interventions such as clipping or coiling Additionally cerebral changes following aSAH including delayed onset cerebral infraction white matter hyperintensities and focal encephalomalacia contribute to cognitive deficits In clinical settings patients with aSAH often demonstrate notable improvements in motor function recovery however cognitive issues such as executive function and complex attention are closely linked to patients inability to perform the activities of daily living ADL independently and return to work even after disease recovery While physical therapy interventions including early mobilization show promise in enhancing functional outcomes there is a dearth of research specifically addressing cognitive rehabilitation in aSAH patients
Integration of motor-cognitive training approaches such as motor-cognitive integrative training MCIT may hold potential for improving cognitive and motor recovery in SAH patients akin to their application in other neurological disorders like Parkinsons disease and stroke Understanding the intricate relationship between cognitive deficits and functional outcomes is crucial for developing targeted rehabilitation strategies to improve the quality of life for aSAH survivors
Purpose This pilot study tests the feasibility logistics and methodology of the research project as well as to identify any potential problems or challenges that may arise In the future the investigators plan to examine the impact of early intervention with MCIT e-MCIT on cognitive function motor recovery functional abilities and ADL in acute SAH patients upon discharge from the ICU and during the post-intervention assessment
Study design This is a pilot study to testify the feasibility logistics and methodology of evaluation and early motor-cognitive integrative training e- MCIT on cognitive function motor recovery functional ability and abilities in ADL in patients with aSAH in acute phase The intervention commences during the acute setting in the ICU period and extends through the subacute phase in the hospitals general ward Evaluation will be conducted at three assessment time points including baseline assessment following initial medical intervention assessment at the time of discharge from the intensive care center ICU and discharge from the hospital After recruiting in this study participants all receive the intervention of e-MCIT If the subjects can complete the tasks the results and completion times will be recorded If the tasks cannot be completed this situation and its probability will be documented as well Due to the large number of measurement items in this study it is expected to take a longer time Breaks will be taken as needed according to each subjects tolerance If the tasks cannot be completed in one session they will be carried over to the next day Our future study will be well-designed according to the result from this study
Method Patients with aSAH will be recruited which Inclusion criteria for enrolment are as follows 1 Diagnosis of spontaneous SAH resulting from aneurysm rupture confirmed by either CT scan or angiography 2 Onset of stroke occurring in the acute phase specifically 2-7 days after medical intervention 3 Participants must be over 18 years old 4 WFNS 1-3 5 Able to stand without support above 30 seconds 6 Montreal Cognitive Assessment MoCA26 Patients who present unstable vital sign eg heart rate HR 40-100bpm mean arterial pressure MAP 80mmHg respiratory rate RR 12-20 oxygen saturation SpO2 95 intracranial pressure ICP 20mmHg and cerebral perfusion pressure CPP 70mmHg according to the criteria in previous study or evaluated as unsuitable by their attending physician will be excluded Participants who are with other neurological disease might interfere the experiment and their education years less than 12 years will be excluded in this study The e-MCIT consists of early mobilization and early cognitive training Intervention will be 30 minutes per session 4-5 sessions per week until discharging from the hospital Outcome measurements includes side-effect events record Montreal Cognitive Assessment MoCA Trail Making Test part ATMT- A Trail Making Test part BTMT-B Stroop color and word test SCWT forward and reverse digit span DS test Go and no-go GNG test Semantic Verbal Fluency test SVFT Fugl-Meyer Assessment for upper extremity FMA- UE and lower extremity FMA-LE Medical Research Council MRC Functional ambulatory category FAC kinematics performance in single and dual task ability brain activity by functional Near-Infrared Spectroscopy fNIRS during all cognition assessment and in single and dual task Functional independence measure FIM Modified Rankin Scale mRS Perme ICU mobility score and National Institutes of Health Stroke Scale NIHSS Statistical analysis was conducted using SPSS version 260 Categorical variables in the descriptive data of the participants were presented as numbers and percentages while continuous variables were expressed as mean standard deviation Nominal variables would be analyzed by X2 test Wilcoxon Signed-Rank Test will be used to test the differences between pre-test and post-intervention time points due to small sample size A two-tailed significance level α was set at 005 Thus p 005 revealed significant difference
Integration of motor-cognitive training approaches such as motor-cognitive integrative training MCIT may hold potential for improving cognitive and motor recovery in SAH patients akin to their application in other neurological disorders like Parkinsons disease and stroke Understanding the intricate relationship between cognitive deficits and functional outcomes is crucial for developing targeted rehabilitation strategies to improve the quality of life for aSAH survivors
Purpose This pilot study tests the feasibility logistics and methodology of the research project as well as to identify any potential problems or challenges that may arise In the future the investigators plan to examine the impact of early intervention with MCIT e-MCIT on cognitive function motor recovery functional abilities and ADL in acute SAH patients upon discharge from the ICU and during the post-intervention assessment
Study design This is a pilot study to testify the feasibility logistics and methodology of evaluation and early motor-cognitive integrative training e- MCIT on cognitive function motor recovery functional ability and abilities in ADL in patients with aSAH in acute phase The intervention commences during the acute setting in the ICU period and extends through the subacute phase in the hospitals general ward Evaluation will be conducted at three assessment time points including baseline assessment following initial medical intervention assessment at the time of discharge from the intensive care center ICU and discharge from the hospital After recruiting in this study participants all receive the intervention of e-MCIT If the subjects can complete the tasks the results and completion times will be recorded If the tasks cannot be completed this situation and its probability will be documented as well Due to the large number of measurement items in this study it is expected to take a longer time Breaks will be taken as needed according to each subjects tolerance If the tasks cannot be completed in one session they will be carried over to the next day Our future study will be well-designed according to the result from this study
Method Patients with aSAH will be recruited which Inclusion criteria for enrolment are as follows 1 Diagnosis of spontaneous SAH resulting from aneurysm rupture confirmed by either CT scan or angiography 2 Onset of stroke occurring in the acute phase specifically 2-7 days after medical intervention 3 Participants must be over 18 years old 4 WFNS 1-3 5 Able to stand without support above 30 seconds 6 Montreal Cognitive Assessment MoCA26 Patients who present unstable vital sign eg heart rate HR 40-100bpm mean arterial pressure MAP 80mmHg respiratory rate RR 12-20 oxygen saturation SpO2 95 intracranial pressure ICP 20mmHg and cerebral perfusion pressure CPP 70mmHg according to the criteria in previous study or evaluated as unsuitable by their attending physician will be excluded Participants who are with other neurological disease might interfere the experiment and their education years less than 12 years will be excluded in this study The e-MCIT consists of early mobilization and early cognitive training Intervention will be 30 minutes per session 4-5 sessions per week until discharging from the hospital Outcome measurements includes side-effect events record Montreal Cognitive Assessment MoCA Trail Making Test part ATMT- A Trail Making Test part BTMT-B Stroop color and word test SCWT forward and reverse digit span DS test Go and no-go GNG test Semantic Verbal Fluency test SVFT Fugl-Meyer Assessment for upper extremity FMA- UE and lower extremity FMA-LE Medical Research Council MRC Functional ambulatory category FAC kinematics performance in single and dual task ability brain activity by functional Near-Infrared Spectroscopy fNIRS during all cognition assessment and in single and dual task Functional independence measure FIM Modified Rankin Scale mRS Perme ICU mobility score and National Institutes of Health Stroke Scale NIHSS Statistical analysis was conducted using SPSS version 260 Categorical variables in the descriptive data of the participants were presented as numbers and percentages while continuous variables were expressed as mean standard deviation Nominal variables would be analyzed by X2 test Wilcoxon Signed-Rank Test will be used to test the differences between pre-test and post-intervention time points due to small sample size A two-tailed significance level α was set at 005 Thus p 005 revealed significant difference
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None