Ignite Creation Date:
2024-06-16 @ 11:50 AM
Last Modification Date:
2024-10-26 @ 3:31 PM
Study NCT ID:
NCT06445998
Status:
COMPLETED
Last Update Posted:
2024-06-06
First Post:
2024-06-01
Brief Title:
Effect of Task Oriented Training on Cognitive Function in Elderly Stroke Patients
Sponsor:
Horus University
Organization:
Horus University
Study Overview
Official Title:
Effect of Task Oriented Training on Cognitive Function in Elderly Stroke Patients
Status:
COMPLETED
Status Verified Date:
2024-06
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:
Background The impact of stroke at the time of diagnosis is on the attention and executive functions which may be impaired at various post-stroke intervals Objective To improve Cognitive Function in Elderly Stroke Patients through Task Oriented Training Subjects and methods Forty Elderly stroke patients from both sexes assigned randomly into two equal groups In Group A were allocated to task oriented training in addition to traditional physical therapy program group B received traditional physical therapy program three sessionsweek for 3 months Cognitive Function assessed by Reha-com device Addenbrookes Cognitive Examination Revised ACE-R test and Montreal Cognitive Assessment Scale MoCA measured at baseline and after 3 months
Detailed Description:
Methods The current study was conducted to examine the influence of task oriented training on cognitive functions in post Elderly stroke patients All patients were diagnosed clinically and radiologically and referred from their neurological consultants as having post stroke cognitive impairment PSCI The patients were chosen and the study was carried- out in outpatient clinics of Faculty of physical therapy Horus University this study was conducted at the period from to
True experimental research design study one factorial RCT pre-test and post-test control group design was utilized One trained research assistant assessed all patients and collected all data to reduce inter-investigator error Patients were randomized according to the treatment procedure into two equal groups
Randomization method Patients who met the studys inclusion criteria were randomized into two groups A and B utilizing a secure opaque closed envelope allocation mechanism Group A study group consisted of twenty hemiparetic patients received task oriented training in addition to traditional physical therapy program 3 times per week for 3 month every session for 1 hour 30 minutes task oriented training followed by 30 minutes traditional physical therapy program Group B control group consisted of twenty hemiparetic patients received the traditional physical therapy program 3 sessionsweek for 3 month each session for 1hour
Blinding All patients were assessed and referred by the same physician and physical therapy evaluation before beginning and at the end of the treatment program Treatment allocations were kept secret from both the researcher and the participants
Inclusion criteria Forty right-handed hemiparetic patients from both genders aged from 60 to 70 years old They are complaining from a single ischemic stroke diagnosed by Neurologist and confirmed radiologically by MRI of the brain Duration of illness ranged from three to twelve months Spasticity grade 1 to 1 based on the Modified Ashworth Scale MAS Medically as well as psychologically stable patients All patients had normal and stable vital signs heart rate blood pressure temperature as well as respiratory rate All patients had a good educational level and the body mass index ranged from 20-30 Kgm2
Exclusion criteria Patients with Recurrent stroke or hemiparesis due to other neurological causes rather than stroke Patients with severe cardiovascular issues that have not been adequately treated Visual auditory and other neurological disorders Patients receiving medications that may affect cognition
Data collection and intervention Assessment methods After being informed of the studys goals methods potential benefits privacy as well as data use all participants signed a written consent form Pre-treatment and post-treatment assessments were conducted on all patients
Measurement procedures
1 Assessment of cognitive function by Reha-com device The computerized Reha-Com device containing the attention and concentration program was utilized as the patient is asked to concentrate on every detail in the separately presented picture and select the one that resembles it in every detail from the matrix as the assessment screen is splitted into two parts One portion represents the matrix that involves according to 24 levels of difficulty 3 pictures 1 by 3 matrix 6 pictures 2 by 3 matrix as well as 9 pictures 3 by 3 matrix and the other part represents the separated picture
2 Addenbrookes Cognitive Examination Revised ACE-R test It consists of 26 tasks divided into five domains It takes about 15 minutes to administer The maximum possible score is 100 and questions are asked in the sequence stated with scores calculated immediately based on the addition of point values for each correctly answered question 10
3 Montreal Cognitive Assessment Scale MoCA
The test is commonly used to screen for cognitive impairment It was designed to detect mild cognitive Impairment It takes approximately 10 minutes to complete 30-point cognitive screening instrument It is utilized to evaluate multiple aspects of cognition including short-term memory visual-spatial skills executive function concentration attention memory for work language as well as time-and-place awareness The possible range of MoCA scores is 0-30 If you scored 26 or more youre in the normal range Scores below 25 indicate mild cognitive impairment MCI in individuals who have suffered a stroke and the score has a high sensitivity 77 as well as specificity 83 11
Intervention methods Task-oriented training program For study group Rocker board training The subject was asked to control anteroposterior then mediolateral rolling movement of the rocking board first placing both feet then one foot first with eyes opened then with eyes closed from sitting then standing position
Wobble board training The subject was asked to try to stop the multidirectional rolling wobble board movement first with eyes opened then with eyes closed from sitting then standing position repeat 10 times
Sit to stand The patient was instructed to lean forward then press on heel then stand up Both hands should be on the thigh and push against it to stand This progress to be performed with opened eyes then with closed eyes firstly on a firm surface then on foam surface with repetitions 10 times
Walk five steps forward From standing position the patient was asked to walk five steps forward firstly on a firm surface then on foam surface and repeat 10 times
Upstairs and downstairs three steps The patient was asked to perform upstairs five steps and downstairs with hand supported then without hand supported repeat 10 times
Traditional physical therapy program For both groups Range of motion exercises Range of motion exercises was performed for the foot The patient was asked to sit in a chair lift the affected foot and circle in a clockwise then a counterclockwise motion Repeat this cycling five and ten times in each direction
Strengthing exercises
Graduate active exercise was used through strengthing of ankle dorsiflexors planterflexor invertors and evertors Proprioceptive neuromuscular facilitation was also applied to strength distal muscles in the form of repeated contraction for dorsiflexors of ankle joint for ten minutes
Sensory re-education
Tactile stimulation for both superficial and deep sensation was applied Gait Training Walking within parallel bar with hand supported then without hand support was participated for ten minutes Obstacles also were used with hand support then without hand support
True experimental research design study one factorial RCT pre-test and post-test control group design was utilized One trained research assistant assessed all patients and collected all data to reduce inter-investigator error Patients were randomized according to the treatment procedure into two equal groups
Randomization method Patients who met the studys inclusion criteria were randomized into two groups A and B utilizing a secure opaque closed envelope allocation mechanism Group A study group consisted of twenty hemiparetic patients received task oriented training in addition to traditional physical therapy program 3 times per week for 3 month every session for 1 hour 30 minutes task oriented training followed by 30 minutes traditional physical therapy program Group B control group consisted of twenty hemiparetic patients received the traditional physical therapy program 3 sessionsweek for 3 month each session for 1hour
Blinding All patients were assessed and referred by the same physician and physical therapy evaluation before beginning and at the end of the treatment program Treatment allocations were kept secret from both the researcher and the participants
Inclusion criteria Forty right-handed hemiparetic patients from both genders aged from 60 to 70 years old They are complaining from a single ischemic stroke diagnosed by Neurologist and confirmed radiologically by MRI of the brain Duration of illness ranged from three to twelve months Spasticity grade 1 to 1 based on the Modified Ashworth Scale MAS Medically as well as psychologically stable patients All patients had normal and stable vital signs heart rate blood pressure temperature as well as respiratory rate All patients had a good educational level and the body mass index ranged from 20-30 Kgm2
Exclusion criteria Patients with Recurrent stroke or hemiparesis due to other neurological causes rather than stroke Patients with severe cardiovascular issues that have not been adequately treated Visual auditory and other neurological disorders Patients receiving medications that may affect cognition
Data collection and intervention Assessment methods After being informed of the studys goals methods potential benefits privacy as well as data use all participants signed a written consent form Pre-treatment and post-treatment assessments were conducted on all patients
Measurement procedures
1 Assessment of cognitive function by Reha-com device The computerized Reha-Com device containing the attention and concentration program was utilized as the patient is asked to concentrate on every detail in the separately presented picture and select the one that resembles it in every detail from the matrix as the assessment screen is splitted into two parts One portion represents the matrix that involves according to 24 levels of difficulty 3 pictures 1 by 3 matrix 6 pictures 2 by 3 matrix as well as 9 pictures 3 by 3 matrix and the other part represents the separated picture
2 Addenbrookes Cognitive Examination Revised ACE-R test It consists of 26 tasks divided into five domains It takes about 15 minutes to administer The maximum possible score is 100 and questions are asked in the sequence stated with scores calculated immediately based on the addition of point values for each correctly answered question 10
3 Montreal Cognitive Assessment Scale MoCA
The test is commonly used to screen for cognitive impairment It was designed to detect mild cognitive Impairment It takes approximately 10 minutes to complete 30-point cognitive screening instrument It is utilized to evaluate multiple aspects of cognition including short-term memory visual-spatial skills executive function concentration attention memory for work language as well as time-and-place awareness The possible range of MoCA scores is 0-30 If you scored 26 or more youre in the normal range Scores below 25 indicate mild cognitive impairment MCI in individuals who have suffered a stroke and the score has a high sensitivity 77 as well as specificity 83 11
Intervention methods Task-oriented training program For study group Rocker board training The subject was asked to control anteroposterior then mediolateral rolling movement of the rocking board first placing both feet then one foot first with eyes opened then with eyes closed from sitting then standing position
Wobble board training The subject was asked to try to stop the multidirectional rolling wobble board movement first with eyes opened then with eyes closed from sitting then standing position repeat 10 times
Sit to stand The patient was instructed to lean forward then press on heel then stand up Both hands should be on the thigh and push against it to stand This progress to be performed with opened eyes then with closed eyes firstly on a firm surface then on foam surface with repetitions 10 times
Walk five steps forward From standing position the patient was asked to walk five steps forward firstly on a firm surface then on foam surface and repeat 10 times
Upstairs and downstairs three steps The patient was asked to perform upstairs five steps and downstairs with hand supported then without hand supported repeat 10 times
Traditional physical therapy program For both groups Range of motion exercises Range of motion exercises was performed for the foot The patient was asked to sit in a chair lift the affected foot and circle in a clockwise then a counterclockwise motion Repeat this cycling five and ten times in each direction
Strengthing exercises
Graduate active exercise was used through strengthing of ankle dorsiflexors planterflexor invertors and evertors Proprioceptive neuromuscular facilitation was also applied to strength distal muscles in the form of repeated contraction for dorsiflexors of ankle joint for ten minutes
Sensory re-education
Tactile stimulation for both superficial and deep sensation was applied Gait Training Walking within parallel bar with hand supported then without hand support was participated for ten minutes Obstacles also were used with hand support then without hand support
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