StrokeNCT06454279
Cognitive Motor Dual Task Versus Task Specific Training on Cognition and Motor Functioning in Stroke Patients
A study testing Dual Task Training and Task Specific Training in people with Stroke, run by Riphah International University at 1 site in Pakistan.
Trial summary
This study focuses on Dual Task Training as daily living involves many dual task conditions, in which a person requires to do two or more tasks at same time. without the ability to carry out these types of Dual movements. Read more about this study
- Who is it for?
- Ages 45 to 75 years
- Conditions the study is for
- Stroke
- What is being tested?
- Dual Task Training and Task Specific Training
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 44 participants
- Where
- 1 sitePakistan
- Study dates
- 30 May 2024to 5 Dec 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 45 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with age ≥ 45 years' old both male and female.
- Patients with Mild cognitive impairment with MOCA score of 18-25.
- Patients with sub-acute or chronic stage of stroke and are able to sit
- independently for 30 secs.
- Patients with primary level education.
Who cannot join
- Patients with dementia that had been diagnosed by a neurologist.
- Patients with neurological, psychiatric, or medical disorders.
- Patients with auditory or visual impairments.
Trial locations and contacts
1 site in 1 country.
Pakistan1 site
National Institute of Rehabilitation sciences
Islamabad, Punjab Province
About this study
Official title: Effects of Cognitive Motor Dual Task Versus Task Specific Training on Cognition and Motor Functioning in Stroke Patients
This study focuses on Dual Task Training as daily living involves many dual task conditions, in which a person requires to do two or more tasks at same time. without the ability to carry out these types of Dual movements. This study aims to improve the ability to do two tasks at same time, targeted to decrease the risk of fall in stroke patients. This study helps in understanding how multiple tasks simultaneously affects patients' abilities and creating effectiveness programs.
Read the detailed description
The World Health Organization (WHO) defines the stroke as a brain injury that causes rapid and noticeable changes in cerebral function, lasting 24 hours or longer, or resulting in death. Strokes can be caused by vascular issues and include cerebral infarction, intracerebral hemorrhage, and subarachnoid hemorrhage. Stroke is a syndrome characterized by acute neurological deficits caused by vascular injury in the central nervous system. It's a major cause of disability and mortality globally, resulting from various risk factors, diseases, and mechanisms. Dual-task training refers to the ability to simultaneously perform multiple cognitive and motor activities while maintaining postural control. Divided attention is the capacity to do more than one thing at the same time. Dual-task training innovatively combines motor and cognitive rehabilitation in a comprehensive module. TST, or task-specific training, is a popular rehab approach that emphasizes function and is commonly used for stroke patients. It's all about targeting specific tasks to help with recovery.
RCT conducted on two groups, Dual Task Training and Task Specific training. interventions applied with a frequency of three times a week for eight weeks protocol. Participants will be divided into 2 groups. 1st group will receive Dual task training for motor and cognition simultaneously. 2nd group will receive task specific training for motor and cognition functioning.
- Conditions
- Stroke
- Being tested
- Dual Task Training, Task Specific Training
- Keywords
- Cognition, Motor Functioning, Stroke
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dual Task TrainingOther
Also called Cognitive task + Motor Task
Exercise which combines cognitive task with motor task e.g Backward counting during sit ups.
Calculation questions during stationary cycle for 10 mins. Sequentially perform movements on commands like normal standing (bipedal support with feet separated at shoulder width, Feet together (bipedal support with feet side by side), Semitandem stance, Tandem stance, one leg support on the dominant leg, one leg support on the nondominant leg by first laterally moving the trunk with shoulder abducted at least above 60 degree
Task Specific TrainingOther
Also called cognitive task and motor task
Wide based gait training.
Auditory forward digit span:
Remember as many as possible of the number/letter forward sequence, you were told
Auditory backward digit span:
Remember as many as possible of the number/letter back sequence, you were told
Visual forward digit span:
Remember as many as possible of the number forward sequence shown to you by means of cardboard
Visual backward digit span:
Remember as many as possible
| Study group | Role | What they receive |
|---|---|---|
| Dual Task Training | Experimental | Dual task exercises for example Crossing over the obstacles placed on their path while answering simple questions "yes" or "no" Walking while bouncing the ball with spell the word like WORLD Picking up an object from the floor. Walking on straight line while Calculation. Tandem walk while counting money Receives: Other: Dual Task Training |
| Task Specific Training | Experimental | Picking up the card, Picking up the right color, Box and block activity, Picking up different shapes, Gait training, Sit/ standing marching. Receives: Other: Task Specific Training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fugl Meyer Assessment Tool
The Fugyl-Meyer scale was developed as the first quantitative evaluative instrument for measuring sensorimotor stroke recovery.
Measured: 8th week
Trail Making Test A and B
The Trail Making Test (TMT) is one of the most popular neuropsychological tests and is included in most test batteries.
Measured: 8 weeks
Secondary outcomes (3)
Digit Span Test
The Digit Sequencing or Digit Span test is one of the main tools developed to measure one's verbal working memory The Digit Sequence test is one of the main tools developed to measure one's verbal working memory, overall intelligence, attention, and cognitive functioning
Measured: 8 weeks
stroop color and word test
The Stroop Color and Word Test (SCWT) is a neuropsychological test extensively used to assess the ability to inhibit cognitive interference that occurs when the processing of a specific stimulus feature impedes the simultaneous processing of a second stimulus attribute, well-known as the Stroop Effect
Measured: 8 weeks
Modified Functional Reach Test
The Modified Functional Reach Test (MFRT) is a simple and adaptive clinical assessment instrument for determining sitting balance, an important part of functional ability.
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jun 2024
- Study start30 May 2024
- Primary completion5 Nov 2024 (estimated)
- Study completion5 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (18)Papers the sponsor has linked to this study.
- Other trials for StrokeStudies of the same condition, open and under way.
- More trials run by Riphah International UniversityThe sponsor's other registered studies.
- 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
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 44 participants (actual)
Sponsor and investigators
- Lead sponsor
- Riphah International University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Bushra Sultana, MSPT, Principal investigator, Riphah International University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06454279
- Sponsor's protocol ID
- REC/MS-PT/018 Qudsia Hafeez
- Status last verified
- Jun 2024
- First submitted
- 6 Jun 2024
- Last updated
- 12 Jun 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Murphy SJ, Werring DJ. Stroke: causes and clinical features. Medicine (Abingdon). 2020 Sep;48(9):561-566. doi: 10.1016/j.mpmed.2020.06.002. Epub 2020 Aug 6.
PubMed 32837228Yeh TT, Chang KC, Wang JJ, Lin WC, Wu CY. Neuroplastic Changes Associated With Hybrid Exercise-Cognitive Training in Stroke Survivors With Mild Cognitive Decline: A Randomized Controlled Trial. Neurorehabil Neural Repair. 2023 Sep;37(9):662-673. doi: 10.1177/15459683231200220.
PubMed 37750660Feigin VL, Brainin M, Norrving B, Martins S, Sacco RL, Hacke W, Fisher M, Pandian J, Lindsay P. World Stroke Organization (WSO): Global Stroke Fact Sheet 2022. Int J Stroke. 2022 Jan;17(1):18-29. doi: 10.1177/17474930211065917.
PubMed 34986727Wolfe CD. The impact of stroke. Br Med Bull. 2000;56(2):275-86. doi: 10.1258/0007142001903120.
PubMed 11092079Langhorne P, Bernhardt J, Kwakkel G. Stroke rehabilitation. Lancet. 2011 May 14;377(9778):1693-702. doi: 10.1016/S0140-6736(11)60325-5.
PubMed 21571152Rost NS, Brodtmann A, Pase MP, van Veluw SJ, Biffi A, Duering M, Hinman JD, Dichgans M. Post-Stroke Cognitive Impairment and Dementia. Circ Res. 2022 Apr 15;130(8):1252-1271. doi: 10.1161/CIRCRESAHA.122.319951. Epub 2022 Apr 14.
PubMed 35420911Traxler K, Schinabeck F, Baum E, Klotz E, Seebacher B. Feasibility of a specific task-oriented training versus its combination with manual therapy on balance and mobility in people post stroke at the chronic stage: study protocol for a pilot randomised controlled trial. Pilot Feasibility Stud. 2021 Jul 27;7(1):146. doi: 10.1186/s40814-021-00886-0.
PubMed 34311772V.Rajalaxmi JA. Effects of Dual Task Training Versus PNF Pattern on Balance and Cognition in geriatrics population. International Journal of Life science and Pharma Research. 2022 July; 12(4).
Xiao Y, Yang T, Shang H. The Impact of Motor-Cognitive Dual-Task Training on Physical and Cognitive Functions in Parkinson's Disease. Brain Sci. 2023 Mar 3;13(3):437. doi: 10.3390/brainsci13030437.
PubMed 36979247Kim KH, Jang SH. Effects of Task-Specific Training after Cognitive Sensorimotor Exercise on Proprioception, Spasticity, and Gait Speed in Stroke Patients: A Randomized Controlled Study. Medicina (Kaunas). 2021 Oct 13;57(10):1098. doi: 10.3390/medicina57101098.
PubMed 34684135Iqbal M, Arsh A, Hammad SM, Haq IU, Darain H. Comparison of dual task specific training and conventional physical therapy in ambulation of hemiplegic stroke patients: A randomized controlled trial. J Pak Med Assoc. 2020 Jan;70(1):7-10. doi: 10.47391/JPMA.10443.
PubMed 31954014Kim H Yeh. Reliability, concurrent validity, and responsiveness of the FuglMeyer Assessment (FMA) for hemiplegic patients. Journal Of Physical Therapy Science. 2012; 24(9): 893.
Marchesi G, Ballardini G, Barone L, Giannoni P, Lentino C, De Luca A, Casadio M. Modified Functional Reach Test: Upper-Body Kinematics and Muscular Activity in Chronic Stroke Survivors. Sensors (Basel). 2021 Dec 29;22(1):230. doi: 10.3390/s22010230.
PubMed 35009772Katz-Leurer M, Fisher I, Neeb M, Schwartz I, Carmeli E. Reliability and validity of the modified functional reach test at the sub-acute stage post-stroke. Disabil Rehabil. 2009;31(3):243-8. doi: 10.1080/09638280801927830.
PubMed 18608433Lam B, Middleton LE, Masellis M, Stuss DT, Harry RD, Kiss A, Black SE. Criterion and convergent validity of the Montreal cognitive assessment with screening and standardized neuropsychological testing. J Am Geriatr Soc. 2013 Dec;61(12):2181-2185. doi: 10.1111/jgs.12541. Epub 2013 Dec 9.
PubMed 24320735
Study at a glance
From the registry record, last updated by the sponsor on 12 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Cognitive Motor Dual Task Versus Task Specific Training on Cognition and Motor Functioning in Stroke Patients
- ClinicalTrials.gov ID
- NCT06454279
- Acronym / sponsor ID
- REC/MS-PT/018 Qudsia Hafeez
- Conditions
- Stroke
- Keywords
- Cognition, Motor Functioning, Stroke
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 44 participants (actual)
- Lead sponsor
- Riphah International UniversityUniversity, hospital or other
- Study start
- 30 May 2024 (actual)
- Primary completion
- 5 Nov 2024 (estimated)
- Study completion
- 5 Dec 2024 (estimated)
- First posted
- 12 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.
This study focuses on Dual Task Training as daily living involves many dual task conditions, in which a person requires to do two or more tasks at same time. without the ability to carry out these types of Dual movements. This study aims to improve the ability to do two tasks at same time, targeted to decrease the risk of fall in stroke patients. This study helps in understanding how multiple tasks simultaneously affects patients' abilities and creating effectiveness programs.
Detailed description
The World Health Organization (WHO) defines the stroke as a brain injury that causes rapid and noticeable changes in cerebral function, lasting 24 hours or longer, or resulting in death. Strokes can be caused by vascular issues and include cerebral infarction, intracerebral hemorrhage, and subarachnoid hemorrhage. Stroke is a syndrome characterized by acute neurological deficits caused by vascular injury in the central nervous system. It's a major cause of disability and mortality globally, resulting from various risk factors, diseases, and mechanisms. Dual-task training refers to the ability to simultaneously perform multiple cognitive and motor activities while maintaining postural control. Divided attention is the capacity to do more than one thing at the same time. Dual-task training innovatively combines motor and cognitive rehabilitation in a comprehensive module. TST, or task-specific training, is a popular rehab approach that emphasizes function and is commonly used for stroke patients. It's all about targeting specific tasks to help with recovery.
RCT conducted on two groups, Dual Task Training and Task Specific training. interventions applied with a frequency of three times a week for eight weeks protocol. Participants will be divided into 2 groups. 1st group will receive Dual task training for motor and cognition simultaneously. 2nd group will receive task specific training for motor and cognition functioning.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Dual Task Training | Experimental | Other: Dual Task TrainingDual task exercises for example Crossing over the obstacles placed on their path while answering simple questions "yes" or "no" Walking while bouncing the ball with spell the word like WORLD Picking up an object from the floor. Walking on straight line while Calculation. Tandem walk while counting money |
| Task Specific Training | Experimental | Other: Task Specific TrainingPicking up the card, Picking up the right color, Box and block activity, Picking up different shapes, Gait training, Sit/ standing marching. |
Who may qualify
- Ages
- 45 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Patients with age ≥ 45 years' old both male and female.
- Patients with Mild cognitive impairment with MOCA score of 18-25.
- Patients with sub-acute or chronic stage of stroke and are able to sit
- independently for 30 secs.
- Patients with primary level education.
Key exclusion criteria (3 listed)
- Patients with dementia that had been diagnosed by a neurologist.
- Patients with neurological, psychiatric, or medical disorders.
- Patients with auditory or visual impairments.
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 |
|---|---|---|
| Dual Task TrainingAlso: Cognitive task + Motor TaskExercise which combines cognitive task with motor task e.g Backward counting during sit ups. Calculation questions during stationary cycle for 10 mins. Sequentially perform movements on commands like normal standing (bipedal support with feet separated at shoulder width, Feet together (bipedal support with feet side by side), Semitandem stance, Tandem stance, one leg support on the dominant leg, one leg support on the nondominant leg by first laterally moving the trunk with shoulder abducted at least above 60 degree | Other | Dual Task Training |
| Task Specific TrainingAlso: cognitive task and motor taskWide based gait training. Auditory forward digit span: Remember as many as possible of the number/letter forward sequence, you were told Auditory backward digit span: Remember as many as possible of the number/letter back sequence, you were told Visual forward digit span: Remember as many as possible of the number forward sequence shown to you by means of cardboard Visual backward digit span: Remember as many as possible | Other | Task Specific Training |
Primary outcome
Fugl Meyer Assessment Tool
Time frame: 8th week
The Fugyl-Meyer scale was developed as the first quantitative evaluative instrument for measuring sensorimotor stroke recovery.
Trail Making Test A and B
Time frame: 8 weeks
The Trail Making Test (TMT) is one of the most popular neuropsychological tests and is included in most test batteries.
3 secondary outcomes
Digit Span Test
Time frame: 8 weeks
stroop color and word test
Time frame: 8 weeks
Modified Functional Reach Test
Time frame: 8 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jun 2024.
- Background: PubMed 32837228Murphy SJ, Werring DJ. Stroke: causes and clinical features. Medicine (Abingdon). 2020 Sep;48(9):561-566. doi: 10.1016/j.mpmed.2020.06.002. Epub 2020 Aug 6.
- Background: PubMed 37750660Yeh TT, Chang KC, Wang JJ, Lin WC, Wu CY. Neuroplastic Changes Associated With Hybrid Exercise-Cognitive Training in Stroke Survivors With Mild Cognitive Decline: A Randomized Controlled Trial. Neurorehabil Neural Repair. 2023 Sep;37(9):662-673. doi: 10.1177/15459683231200220.
- Background: PubMed 34986727Feigin VL, Brainin M, Norrving B, Martins S, Sacco RL, Hacke W, Fisher M, Pandian J, Lindsay P. World Stroke Organization (WSO): Global Stroke Fact Sheet 2022. Int J Stroke. 2022 Jan;17(1):18-29. doi: 10.1177/17474930211065917.
- Background: PubMed 11092079Wolfe CD. The impact of stroke. Br Med Bull. 2000;56(2):275-86. doi: 10.1258/0007142001903120.
- Background: PubMed 21571152Langhorne P, Bernhardt J, Kwakkel G. Stroke rehabilitation. Lancet. 2011 May 14;377(9778):1693-702. doi: 10.1016/S0140-6736(11)60325-5.
- Background: PubMed 35420911Rost NS, Brodtmann A, Pase MP, van Veluw SJ, Biffi A, Duering M, Hinman JD, Dichgans M. Post-Stroke Cognitive Impairment and Dementia. Circ Res. 2022 Apr 15;130(8):1252-1271. doi: 10.1161/CIRCRESAHA.122.319951. Epub 2022 Apr 14.
- Background: PubMed 34311772Traxler K, Schinabeck F, Baum E, Klotz E, Seebacher B. Feasibility of a specific task-oriented training versus its combination with manual therapy on balance and mobility in people post stroke at the chronic stage: study protocol for a pilot randomised controlled trial. Pilot Feasibility Stud. 2021 Jul 27;7(1):146. doi: 10.1186/s40814-021-00886-0.
- BackgroundV.Rajalaxmi JA. Effects of Dual Task Training Versus PNF Pattern on Balance and Cognition in geriatrics population. International Journal of Life science and Pharma Research. 2022 July; 12(4).
- Background: PubMed 36979247Xiao Y, Yang T, Shang H. The Impact of Motor-Cognitive Dual-Task Training on Physical and Cognitive Functions in Parkinson's Disease. Brain Sci. 2023 Mar 3;13(3):437. doi: 10.3390/brainsci13030437.
- Background: PubMed 34684135Kim KH, Jang SH. Effects of Task-Specific Training after Cognitive Sensorimotor Exercise on Proprioception, Spasticity, and Gait Speed in Stroke Patients: A Randomized Controlled Study. Medicina (Kaunas). 2021 Oct 13;57(10):1098. doi: 10.3390/medicina57101098.
- Background: PubMed 31954014Iqbal M, Arsh A, Hammad SM, Haq IU, Darain H. Comparison of dual task specific training and conventional physical therapy in ambulation of hemiplegic stroke patients: A randomized controlled trial. J Pak Med Assoc. 2020 Jan;70(1):7-10. doi: 10.47391/JPMA.10443.
- BackgroundKim H Yeh. Reliability, concurrent validity, and responsiveness of the FuglMeyer Assessment (FMA) for hemiplegic patients. Journal Of Physical Therapy Science. 2012; 24(9): 893.
- Individual participant dataSharing planned: No
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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.
Bushra Sultana, MSPT principal investigator
Riphah International University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Dual Task Training and Task Specific Training in people with Stroke, run by Riphah International University at 1 site in Pakistan.
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 5 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: status not confirmed, as of the sponsor's last update on 12 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 Pakistan. 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?
Results are not available in the source record.
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?
Fugl Meyer Assessment Tool (time frame: 8th week). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06454279, which also lists 18 linked publications.
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 12 Jun 2024.