StrokeNCT06130891
Effects of Cognitive Exercises With Sensory Motor Relearning Program on Upper Limb Function in Sub-Acute Stroke Patients
A study testing Cognitive sensory motor relearning, Sensory motor relearning and Motor Relearning in people with Stroke and Ischemic, run by Riphah International University at 1 site in Pakistan.
Trial summary
The goal of this clinical trial is to compare the effects of cognitive sensory motor relearning, and sensory-motor relearning program alone on manual ability, sensation, gross and fine movements, and cognition in post-stroke patients. Read more about this study
- Who is it for?
- Ages 45 to 60 years
- What is being tested?
- Cognitive sensory motor relearning, Sensory motor relearning and Motor Relearning
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 sitePakistan
- Study dates
- 5 Nov 2023to 30 Mar 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 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Both male and female patients.
- 45- 60 years of age.
- 1st ever stroke.
- Sub-acute ischemic stroke.
- 8-12 weeks post stroke patients.
- Participants must have motor and somatosensory deficits in the upper limb on the affected side, as indicated by an ARAT score between 40 and 50 out of 57.
Show all 9Show fewer
- Participants must be able to provide informed consent or have a legal representative who can provide informed consent on their behalf.
- MoCA score between 18-24
- Modified Ashworth scale < +1
Who cannot join
- Participants who have a history of significant neurological or psychiatric disorders, other than stroke, that could interfere with upper limb motor or sensory recovery.
- Participants who have other medical conditions that could interfere with therapy or assessments, such as severe arthritis or joint injuries.
- Participants who have severe visual or hearing impairments that would interfere with therapy or assessments.
- Participants who are currently participating in another clinical trial or research study.
Trial locations and contacts
1 site in 1 country.
Pakistan1 site
THQ Hospital, Muridke, Sheikhupura, Punjab
Sheikhupura, Punjab Province, 39000
About this study
The goal of this clinical trial is to compare the effects of cognitive sensory motor relearning, and sensory-motor relearning program alone on manual ability, sensation, gross and fine movements, and cognition in post-stroke patients. The main aim is to evaluate the effectiveness of an integrated approach and its impact on motor function, sensory processing, and cognitive skills in sub-acute stroke patients, with the goal of contributing to the development of more efficient rehabilitation interventions for UL sensory-motor impairments after stroke.
Read the detailed description
Stroke is not only associated with a high mortality rate, but It also leads to major disabilities. The American Heart Association reported that nearly 75% of stroke victims have dysfunction and 15-30% of stroke survivors have severe disability. Stroke survivors often suffer from impaired motor function, sensory processing, and cognitive abilities depending on the severity and site of the lesion, severely impacting their functional independence and quality of life. About 80% of stroke survivors experience some degree of impairment in their UL which includes loss of dexterity, abnormal muscle tone, loss of coordinated movements, and diminished sensations depending upon to nature of the lesion.
Cognitive exercise treatment is a motor learning model that focuses on high-level cognitive function and occurs through the integration of perception-cognition-activity processes, such as motor regulation. Activation of the brain's cognitive process, which includes perception, memory, attention, language, and decision-making, is the core of cognitive training. Most studies have focused on either sensory, motor, or cognitive interventions separately, overlooking the potential benefits of simultaneously addressing these domains. This combined intervention targets not only motor skills, but also cognitive skills, sensory processing, and manual dexterity. By addressing physical and cognitive domains simultaneously, this study aims to evaluate the effectiveness of an integrated approach and its impact on motor function, sensory processing, and cognitive skills in sub-acute ischemic stroke patients, with the goal of contributing to the development of more efficient rehabilitation interventions for UL sensory-motor impairments after stroke.
- Being tested
- Cognitive sensory motor relearning, Sensory motor relearning, Motor Relearning
- Keywords
- cognitive exercise therapy, sensory motor relearning, upper limb function
- Medical subject headings
- Stroke, Ischemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cognitive sensory motor relearningOther
Cognitive Exercises:
- Orientation: Checking awareness of date, time, and weather.
- Attention: Tasks like connecting dots or spotting differences.
- Shape Sorting: Sorting objects by size, color, etc.
- Calculation Training: Counting money, beads, basic arithmetic.
- Memory: Recalling objects on a tray, numbers backward, word associations.
Sensory Relearning:
- Discrimination: Identifying textures, shapes, sizes, and temperatures.
- Tactile Recognition: Recognizing objects through touch.
- Proprioception: Matching affected limb's position to unaffected limb's.
Motor Relearning:
- Task-Specific Training: Grasping, pouring, wiping, screwing, holding objects.
- Progression: Increasing duration, intensity, and resistance. 45 minutes per day, 5 days a week for 6 weeks.
Sensory motor relearningOther
Sensory Relearning:
- Discrimination: Identifying textures, shapes, sizes, and temperatures.
- Tactile Recognition: Recognizing objects through touch.
- Proprioception: Matching affected limb's position to unaffected limb's.
Motor Relearning:
- Task-Specific Training: Grasping, pouring, wiping, screwing, holding objects.
- Progression: Increasing duration, intensity, and resistance. 45 minutes per day, 5 days a week for 6 weeks.
Motor RelearningOther
Motor Relearning:
- Task-Specific Training: Grasping, pouring, wiping, screwing, holding objects.
- Progression: Increasing duration, intensity, and resistance. 45 minutes per day, 5 days a week for 6 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Cognitive sensory motor relearning Group | Experimental | Cognitive, sensory, and motor training Receives: Other: Cognitive sensory motor relearning |
| Sensory Motor Relearning Group | Experimental | Sensory and motor training Receives: Other: Sensory motor relearning |
| Motor Relearning Group | Experimental | Motor training Receives: Other: Motor Relearning |
What is being measured
The primary outcome is the main question the study is designed to answer.
Action Research Arm Test
Changes from baseline The instrument contains 19 items grouped into 4 sub-tests: grasp, grip, pinch, and gross motor. Item performance is rated on a 4-point scale (0=unable; 1=partial; 2= abnormal; 3=normal) then item ratings are summed and reported out of 57 points with higher score indicating greater UE function.
Measured: 6 weeks
Revised Nottingham Sensory Assessment (Somatosensory Impairments)
Changes from baseline rNSA examines somatosensory impairment using a 3-point scale (0 =absent, 1 = impaired, 2 = normal) and takes approximately 25-35 min to complete. It consists of 72 items grouped into three sub-scales measuring tactile sensation, proprioception, and stereognosis. The Tactile Sensation subscale includes light touch, temperature, pinprick, pressure, tactile localization, and bilateral simultaneous touch. Higher scores demonstrate better somatosensory function.
Measured: 6 weeks
ABILHAND questionnaire (ABIL)
Changes from baseline ABILHAND is an inventory of 23 manual activities that the patient is originally asked to judge on a 3-level scale: 0 (impossible), 1 (difficult), and 2 (easy). The test explores bi-manual activities done without other human or technical help. For each question the patient provided his/her feeling of difficulty irrespective of the limb(s) actually used to do the activity. Activities not attempted in the last 3 months are not scored and encoded as missing responses.
Measured: 6 weeks
MoCA (Montreal Cognitive Assessment)
Changes from baseline Montreal Cognitive Assessment (MoCA) is a one-page, 30-point cognitive screening measurement scale that takes about 10 minutes to administer. There are 12 subtasks in the MoCA test that include memory, visuospatial orientation, executive functioning, phonemic fluency, and two-item abstract thinking task, attention, concentration, and working memory, language, orientation to time and place. A score of 26 is a cutoff score to differentiate between normal and abnormal.
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Nov 2023
- Study start5 Nov 2023
- Primary completion30 Mar 2024
- Study completion30 Mar 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.
- 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
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Riphah International University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Aruba Saeed, PhD, Principal investigator, Riphah International University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06130891
- Sponsor's protocol ID
- REC/ 0244 Hifsa Waheed
- Status last verified
- May 2024
- First submitted
- 9 Nov 2023
- Last updated
- 7 May 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Cognitive Exercises With Sensory Motor Relearning Program on Upper Limb Function in Sub-Acute Stroke Patients
- ClinicalTrials.gov ID
- NCT06130891
- Acronym / sponsor ID
- REC/ 0244 Hifsa Waheed
- Keywords
- cognitive exercise therapy, sensory motor relearning, upper limb function
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Riphah International UniversityUniversity, hospital or other
- Study start
- 5 Nov 2023 (actual)
- Primary completion
- 30 Mar 2024 (actual)
- Study completion
- 30 Mar 2024 (actual)
- First posted
- 14 Nov 2023 (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.
The goal of this clinical trial is to compare the effects of cognitive sensory motor relearning, and sensory-motor relearning program alone on manual ability, sensation, gross and fine movements, and cognition in post-stroke patients. The main aim is to evaluate the effectiveness of an integrated approach and its impact on motor function, sensory processing, and cognitive skills in sub-acute stroke patients, with the goal of contributing to the development of more efficient rehabilitation interventions for UL sensory-motor impairments after stroke.
Detailed description
Stroke is not only associated with a high mortality rate, but It also leads to major disabilities. The American Heart Association reported that nearly 75% of stroke victims have dysfunction and 15-30% of stroke survivors have severe disability. Stroke survivors often suffer from impaired motor function, sensory processing, and cognitive abilities depending on the severity and site of the lesion, severely impacting their functional independence and quality of life. About 80% of stroke survivors experience some degree of impairment in their UL which includes loss of dexterity, abnormal muscle tone, loss of coordinated movements, and diminished sensations depending upon to nature of the lesion.
Cognitive exercise treatment is a motor learning model that focuses on high-level cognitive function and occurs through the integration of perception-cognition-activity processes, such as motor regulation. Activation of the brain's cognitive process, which includes perception, memory, attention, language, and decision-making, is the core of cognitive training. Most studies have focused on either sensory, motor, or cognitive interventions separately, overlooking the potential benefits of simultaneously addressing these domains. This combined intervention targets not only motor skills, but also cognitive skills, sensory processing, and manual dexterity. By addressing physical and cognitive domains simultaneously, this study aims to evaluate the effectiveness of an integrated approach and its impact on motor function, sensory processing, and cognitive skills in sub-acute ischemic stroke patients, with the goal of contributing to the development of more efficient rehabilitation interventions for UL sensory-motor impairments after stroke.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Cognitive sensory motor relearning Group | Experimental | Other: Cognitive sensory motor relearningCognitive, sensory, and motor training |
| Sensory Motor Relearning Group | Experimental | Other: Sensory motor relearningSensory and motor training |
| Motor Relearning Group | Experimental | Other: Motor RelearningMotor training |
Who may qualify
- Ages
- 45 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (9 listed)
- Both male and female patients.
- 45- 60 years of age.
- 1st ever stroke.
- Sub-acute ischemic stroke.
- 8-12 weeks post stroke patients.
Key exclusion criteria (4 listed)
- Participants who have a history of significant neurological or psychiatric disorders, other than stroke, that could interfere with upper limb motor or sensory recovery.
- Participants who have other medical conditions that could interfere with therapy or assessments, such as severe arthritis or joint injuries.
- Participants who have severe visual or hearing impairments that would interfere with therapy or assessments.
- Participants who are currently participating in another clinical trial or research study.
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 |
|---|---|---|
| Cognitive sensory motor relearningCognitive Exercises: * Orientation: Checking awareness of date, time, and weather. * Attention: Tasks like connecting dots or spotting differences. * Shape Sorting: Sorting objects by size, color, etc. * Calculation Training: Counting money, beads, basic arithmetic. * Memory: Recalling objects on a tray, numbers backward, word associations. Sensory Relearning: * Discrimination: Identifying textures, shapes, sizes, and temperatures. * Tactile Recognition: Recognizing objects through touch. * Proprioception: Matching affected limb's position to unaffected limb's. Motor Relearning: * Task-Specific Training: Grasping, pouring, wiping, screwing, holding objects. * Progression: Increasing duration, intensity, and resistance. 45 minutes per day, 5 days a week for 6 weeks. | Other | Cognitive sensory motor relearning Group |
| Sensory motor relearningSensory Relearning: * Discrimination: Identifying textures, shapes, sizes, and temperatures. * Tactile Recognition: Recognizing objects through touch. * Proprioception: Matching affected limb's position to unaffected limb's. Motor Relearning: * Task-Specific Training: Grasping, pouring, wiping, screwing, holding objects. * Progression: Increasing duration, intensity, and resistance. 45 minutes per day, 5 days a week for 6 weeks. | Other | Sensory Motor Relearning Group |
| Motor RelearningMotor Relearning: * Task-Specific Training: Grasping, pouring, wiping, screwing, holding objects. * Progression: Increasing duration, intensity, and resistance. 45 minutes per day, 5 days a week for 6 weeks. | Other | Motor Relearning Group |
Primary outcome
Action Research Arm Test
Time frame: 6 weeks
Changes from baseline The instrument contains 19 items grouped into 4 sub-tests: grasp, grip, pinch, and gross motor. Item performance is rated on a 4-point scale (0=unable; 1=partial; 2= abnormal; 3=normal) then item ratings are summed and reported out of 57 points with higher score indicating greater UE function.
Revised Nottingham Sensory Assessment (Somatosensory Impairments)
Time frame: 6 weeks
Changes from baseline rNSA examines somatosensory impairment using a 3-point scale (0 =absent, 1 = impaired, 2 = normal) and takes approximately 25-35 min to complete. It consists of 72 items grouped into three sub-scales measuring tactile sensation, proprioception, and stereognosis. The Tactile Sensation subscale includes light touch, temperature, pinprick, pressure, tactile localization, and bilateral simultaneous touch. Higher scores demonstrate better somatosensory function.
ABILHAND questionnaire (ABIL)
Time frame: 6 weeks
Changes from baseline ABILHAND is an inventory of 23 manual activities that the patient is originally asked to judge on a 3-level scale: 0 (impossible), 1 (difficult), and 2 (easy). The test explores bi-manual activities done without other human or technical help. For each question the patient provided his/her feeling of difficulty irrespective of the limb(s) actually used to do the activity. Activities not attempted in the last 3 months are not scored and encoded as missing responses.
MoCA (Montreal Cognitive Assessment)
Time frame: 6 weeks
Changes from baseline Montreal Cognitive Assessment (MoCA) is a one-page, 30-point cognitive screening measurement scale that takes about 10 minutes to administer. There are 12 subtasks in the MoCA test that include memory, visuospatial orientation, executive functioning, phonemic fluency, and two-item abstract thinking task, attention, concentration, and working memory, language, orientation to time and place. A score of 26 is a cutoff score to differentiate between normal and abnormal.
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 7 May 2024.
- 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.
Aruba Saeed, PhD 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 Cognitive sensory motor relearning, Sensory motor relearning and Motor Relearning in people with Stroke and Ischemic, 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 9 inclusion and 4 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 7 May 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?
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?
Action Research Arm Test (time frame: 6 weeks). The study lists 4 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 7 May 2024.