StrokeNCT06445998
Effect of Task Oriented Training on Cognitive Function in Elderly Stroke Patients
A study testing task oriented training in people with Stroke, run by Horus University at 1 site in Egypt.
Trial 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. Read more about this study
- Who is it for?
- Ages 60 to 70 years
- Conditions the study is for
- Stroke
- What is being tested?
- task oriented training
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteEgypt
- Study dates
- 1 May 2024to 31 May 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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 Kg/m2.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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 sessions/week for 3 months. Cognitive Function assessed by Reha-com device, Addenbrooke's Cognitive Examination Revised (ACE-R) test and Montreal Cognitive Assessment Scale (MoCA), measured at baseline and after 3 months.
Read the 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 study's 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 sessions/week 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 Kg/m2.
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 study's 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:
- 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.
- Addenbrooke's 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).
- 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, you're 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.
- Conditions
- Stroke
- Being tested
- task oriented training
- Keywords
- Task Oriented Training - Cognitive Function
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
task oriented trainingOther
Task-oriented training program: [For study group] Rocker board training Wobble board training Sit to stand Walk five steps forward Upstairs and downstairs three steps
| Study group | Role | What they receive |
|---|---|---|
| Group A (study group) | Experimental | 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). Receives: Other: task oriented training |
| Group B (control group) | Active comparator | consisted of twenty hemiparetic patients received the traditional physical therapy program, 3 sessions/week for 3 month, each session for 1hour. Receives: Other: task oriented training |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 3 month
2- Addenbrooke's 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).
Measured: 3 month
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, you're 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).
Measured: 3 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jun 2024
- Study start1 May 2024
- Primary completion31 May 2024
- Study completion31 May 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for StrokeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- task oriented training
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Horus University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ahmed Metwally Mohamed Elshinnawy, Horus University
- Investigators
- Zeezy S Eraky, Lecturer, Study chair, Department of Physical Therapy for Internal Medicine and ElderlyHaitham M. Elmasry, Lecturer, Study chair, Department of Basic ScienceIbrahim M. Hamoda, Asst Prof, Study chair, Department of Physical Therapy for Neuromuscular Disorders and its Surgery
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06445998
- Sponsor's protocol ID
- HorusU
- Status last verified
- Jun 2024
- First submitted
- 1 Jun 2024
- Last updated
- 6 Jun 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: All the IPD will be shared Through the Corresponding author after acceptance of all authors
Study at a glance
From the registry record, last updated by the sponsor on 6 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Task Oriented Training on Cognitive Function in Elderly Stroke Patients
- ClinicalTrials.gov ID
- NCT06445998
- Acronym / sponsor ID
- HorusU
- Conditions
- Stroke
- Keywords
- Task Oriented Training - Cognitive Function
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Horus UniversityUniversity, hospital or other
- Study start
- 1 May 2024 (actual)
- Primary completion
- 31 May 2024 (actual)
- Study completion
- 31 May 2024 (actual)
- First posted
- 6 Jun 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 sessions/week for 3 months. Cognitive Function assessed by Reha-com device, Addenbrooke's 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 study's 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 sessions/week 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 Kg/m2.
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 study's 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:
- 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.
- Addenbrooke's 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).
- 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, you're 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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- task oriented training
| Arm | Type | Receives |
|---|---|---|
| Group A (study group) | Experimental | Other: task oriented trainingconsisted 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) | Active comparator | Other: task oriented trainingconsisted of twenty hemiparetic patients received the traditional physical therapy program, 3 sessions/week for 3 month, each session for 1hour. |
Who may qualify
- Ages
- 60 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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 Kg/m2.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| task oriented trainingTask-oriented training program: [For study group] Rocker board training Wobble board training Sit to stand Walk five steps forward Upstairs and downstairs three steps | Other | Group A (study group), Group B (control group) |
Primary outcome
1- Assessment of cognitive function by Reha-com device
Time frame: 3 month
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- Addenbrooke's Cognitive Examination Revised (ACE-R) test
Time frame: 3 month
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):
Time frame: 3 month
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, you're 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).
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jun 2024.
- Individual participant dataSharing planned: Undecided. All the IPD will be shared Through the Corresponding author after acceptance of all authors
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Zeezy S Eraky, Lecturer study chair
Department of Physical Therapy for Internal Medicine and Elderly
Haitham M. Elmasry, Lecturer study chair
Department of Basic Science
Ibrahim M. Hamoda, Asst Prof study chair
Department of Physical Therapy for Neuromuscular Disorders and its Surgery
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing task oriented training in people with Stroke, run by Horus University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
1- Assessment of cognitive function by Reha-com device (time frame: 3 month). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Jun 2024; AzTrials last refreshed its copy on 30 Oct 2026.