StrokeNCT06251661
Cognitive Multi-sensory Rehabilitation on Upper Limb Function and Fatigue in Stroke
A study testing Cognitive multi-sensory Rehabilition and selected traditional physical therapy program. in people with Stroke and Ischemic, run by Cairo University at 1 site in Egypt.
Trial summary
This interventional study aims to investigate the therapeutic efficacy of Cognitive multi-sensory rehabilitation (CMR) on upper limb function and fatigue in chronic stroke patients. Read more about this study
- Who is it for?
- Ages 45 to 65 years, men only
- What is being tested?
- Cognitive multi-sensory Rehabilition and selected traditional physical therapy program.
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Feb 2023to 28 Feb 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 65 years
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age between 45 and 65 years.
- 6-18 months after ischemic stroke
- living in the community (i.e., not in a long-term care home).
- medically stable.
- normal score in the Montreal Cognitive Assessment (MoCA: 25 to 30, maximum score = 30).
- Spasticity of upper limb muscles ranged from (grade 1:2) according to the Modified Ashworth scale.
Who cannot join
- severe spasticity (Modified Ashworth Scale score of 4)
- any medical condition that hinders full participation,
- another neurological diagnosis beyond stroke including cognitive impairment, or
- upper extremity pain > 4/10 on the Numeric Pain Rating Scale (maximum 10/10).
Trial locations and contacts
1 site in 1 country.
Egypt1 site
Faculty of Physical Therapy Cairo University
Cairo, Giza Governorate, 12612
About this study
Official title: Cognitive Multi-sensory Rehabilitation on Upper Limb Functions and Fatigue in Different Grades of Spasticity in Stroke Patients
This interventional study aims to investigate the therapeutic efficacy of Cognitive multi-sensory rehabilitation (CMR) on upper limb function and fatigue in chronic stroke patients. The main question is:
- Does cognitive multi-sensory rehabilitation significantly affect upper limb function and fatigue in stroke patients? Participants will be assigned into two groups. They will receive 12 sessions of study group CMR and traditional physical therapy and control group traditional physical Therapy rehabilitation. CMR 40 minutes immediately followed by 20 minutes of selected physical therapy program, three sessions per week for four weeks.
Read the detailed description
About 70% of people with stroke are unable to use their affected hand efficiently in activities of daily living. Further, post-stroke fatigue affects up to 92% of post-stroke patients. Post-stroke fatigue is a multifaceted motor and cognitive process, in which the patient experiences tiredness and lack of energy that develops during physical or mental activity which may persist for years. Post-stroke fatigue impacts the mental/physical functions of the patient through decreased energy, and thus, is a significant barrier to recovery.
Preliminary evidence indicates sensory rehabilitation may enhance motor recovery in people with stroke. Cognitive Multisensory Rehabilitation (CMR) is a therapist-guided sensorimotor rehabilitation approach, that targets the patients' ability to solve sensory discrimination exercises, where the patient compares the sensations felt by the hand to the shapes observed with the eyes. Cognitive processes are encouraged by asking the patient to determine the limb movement or its position, how the movement was felt in the body, how the limb moved in relation to other parts of the body, and to spatial parameters in the environment. Because CMR integrates cognitive processes with sensory and motor tasks, it may be a novel method to address post-stroke fatigue, and it may increase connectivity in sensory and motor areas of the brain.
- Being tested
- Cognitive multi-sensory Rehabilition, selected traditional physical therapy program.
- Keywords
- CMR, Stroke, upper limb function, fatigue
- Medical subject headings
- Stroke, Ischemia, Fatigue
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cognitive multi-sensory RehabilitionOther
Kinetic awareness: Initially, only one joint will be moved at a time. Then the therapist will reposition the joint and ask the participants to report their perception of the joint position. Initially, the participants will distinguish between just two positions. If they reliably answer correctly, increase up to five points and integrate speed and dexterity in functional movements. Participants will be asked to relax and feel the movement during this training. Discrimination exercise: The therapist places a part of the participant's limb, the fingertip, on an external object (a block) and the participant will be asked to actively move his or her limb over the object and try to sense the shape of the object. If the participants differentiate between the two objects, then increase the number of objects (up to five). Functional training: The patient reaches toward many objects functionally (cup, ball, cane) from different angles, holds them, and relocates them again.
selected traditional physical therapy program.Other
The selected physical therapy program session will be occupational therapy training for the hand, strengthening exercises for the weak upper limb stretching exercises for short upper limb muscles, balance exercise, and gait training.
| Study group | Role | What they receive |
|---|---|---|
| Group 1 (GA) | Active comparator | 20 Egyptian ischemic stroke patients receive 12 sessions of CMR and traditional physical therapy each session lasts for 40 minutes of CMR and 30 minutes of traditional physical therapy. Receives: Other: Cognitive multi-sensory Rehabilition; Other: selected traditional physical therapy program. |
| Group 2 (GB) | Sham comparator | 20 Egyptian ischemic stroke patients receive 12 sessions of traditional physical therapy each session lasts for 30 minutes. Receives: Other: selected traditional physical therapy program. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fugl-Meyer Assessment for upper extremity (FMT-UE).
Changes in upper limb function.
Measured: from baseline to four weeks after the beginning of intervention
Serum levels of Brain-Derived Neurotrophic Factor (BDNF)
Changes in serum levels of neural plasticity factors
Measured: from baseline to four weeks after the beginning of intervention
Changes in hand grip strength
Hand grip strength was measured by an electronic hand dynamometer device.
Measured: from baseline to four weeks after the beginning of intervention
Fatigue Assessment Scale (FAS)
determine the degree of self-reported fatigue in daily living activities.
Each item of the FAS is answered using a fi ve-point, Likert-type scale ranging from 1 ("never") to 5 ("always"). Items 4 and 10 are reverse-scored. Total scores can range from 10, indicating the lowest level of fatigue, to 50, denoting the highest.
Measured: from baseline to four weeks after the beginning of intervention
Secondary outcomes (1)
Box and Blocks Test (BBT)
Changes in gross hand function intervention.
Measured: from baseline to four weeks after beginning of the intervention.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Feb 2024
- Study start1 Feb 2023
- Primary completion14 Feb 2024
- Study completion28 Feb 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 Cairo 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gehad Mohamed Mohamdeen Ali Mohamed, Cairo University
- Investigators
- Nahed Salem, professor, Study director, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06251661
- Sponsor's protocol ID
- CMR stroke
- Status last verified
- Jan 2026
- First submitted
- 1 Feb 2024
- Last updated
- 21 Jan 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cognitive Multi-sensory Rehabilitation on Upper Limb Functions and Fatigue in Different Grades of Spasticity in Stroke Patients
- ClinicalTrials.gov ID
- NCT06251661
- Acronym / sponsor ID
- CMR stroke
- Keywords
- CMR, Stroke, upper limb function, fatigue
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 1 Feb 2023 (actual)
- Primary completion
- 14 Feb 2024 (actual)
- Study completion
- 28 Feb 2024 (actual)
- First posted
- 9 Feb 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 interventional study aims to investigate the therapeutic efficacy of Cognitive multi-sensory rehabilitation (CMR) on upper limb function and fatigue in chronic stroke patients. The main question is:
- Does cognitive multi-sensory rehabilitation significantly affect upper limb function and fatigue in stroke patients? Participants will be assigned into two groups. They will receive 12 sessions of study group CMR and traditional physical therapy and control group traditional physical Therapy rehabilitation. CMR 40 minutes immediately followed by 20 minutes of selected physical therapy program, three sessions per week for four weeks.
Detailed description
About 70% of people with stroke are unable to use their affected hand efficiently in activities of daily living. Further, post-stroke fatigue affects up to 92% of post-stroke patients. Post-stroke fatigue is a multifaceted motor and cognitive process, in which the patient experiences tiredness and lack of energy that develops during physical or mental activity which may persist for years. Post-stroke fatigue impacts the mental/physical functions of the patient through decreased energy, and thus, is a significant barrier to recovery.
Preliminary evidence indicates sensory rehabilitation may enhance motor recovery in people with stroke. Cognitive Multisensory Rehabilitation (CMR) is a therapist-guided sensorimotor rehabilitation approach, that targets the patients' ability to solve sensory discrimination exercises, where the patient compares the sensations felt by the hand to the shapes observed with the eyes. Cognitive processes are encouraged by asking the patient to determine the limb movement or its position, how the movement was felt in the body, how the limb moved in relation to other parts of the body, and to spatial parameters in the environment. Because CMR integrates cognitive processes with sensory and motor tasks, it may be a novel method to address post-stroke fatigue, and it may increase connectivity in sensory and motor areas of the brain.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group 1 (GA) | Active comparator | Other: Cognitive multi-sensory Rehabilition, Other: selected traditional physical therapy program.20 Egyptian ischemic stroke patients receive 12 sessions of CMR and traditional physical therapy each session lasts for 40 minutes of CMR and 30 minutes of traditional physical therapy. |
| Group 2 (GB) | Sham comparator | Other: selected traditional physical therapy program.20 Egyptian ischemic stroke patients receive 12 sessions of traditional physical therapy each session lasts for 30 minutes. |
Who may qualify
- Ages
- 45 to 65 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Age between 45 and 65 years.
- 6-18 months after ischemic stroke
- living in the community (i.e., not in a long-term care home).
- medically stable.
- normal score in the Montreal Cognitive Assessment (MoCA: 25 to 30, maximum score = 30).
Key exclusion criteria (4 listed)
- severe spasticity (Modified Ashworth Scale score of 4)
- any medical condition that hinders full participation,
- another neurological diagnosis beyond stroke including cognitive impairment, or
- upper extremity pain > 4/10 on the Numeric Pain Rating Scale (maximum 10/10).
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 multi-sensory RehabilitionKinetic awareness: Initially, only one joint will be moved at a time. Then the therapist will reposition the joint and ask the participants to report their perception of the joint position. Initially, the participants will distinguish between just two positions. If they reliably answer correctly, increase up to five points and integrate speed and dexterity in functional movements. Participants will be asked to relax and feel the movement during this training. Discrimination exercise: The therapist places a part of the participant's limb, the fingertip, on an external object (a block) and the participant will be asked to actively move his or her limb over the object and try to sense the shape of the object. If the participants differentiate between the two objects, then increase the number of objects (up to five). Functional training: The patient reaches toward many objects functionally (cup, ball, cane) from different angles, holds them, and relocates them again. | Other | Group 1 (GA) |
| selected traditional physical therapy program.The selected physical therapy program session will be occupational therapy training for the hand, strengthening exercises for the weak upper limb stretching exercises for short upper limb muscles, balance exercise, and gait training. | Other | Group 1 (GA), Group 2 (GB) |
Primary outcome
Fugl-Meyer Assessment for upper extremity (FMT-UE).
Time frame: from baseline to four weeks after the beginning of intervention
Changes in upper limb function.
Serum levels of Brain-Derived Neurotrophic Factor (BDNF)
Time frame: from baseline to four weeks after the beginning of intervention
Changes in serum levels of neural plasticity factors
Changes in hand grip strength
Time frame: from baseline to four weeks after the beginning of intervention
Hand grip strength was measured by an electronic hand dynamometer device.
Fatigue Assessment Scale (FAS)
Time frame: from baseline to four weeks after the beginning of intervention
determine the degree of self-reported fatigue in daily living activities. Each item of the FAS is answered using a fi ve-point, Likert-type scale ranging from 1 ("never") to 5 ("always"). Items 4 and 10 are reverse-scored. Total scores can range from 10, indicating the lowest level of fatigue, to 50, denoting the highest.
1 secondary outcome
Box and Blocks Test (BBT)
Time frame: from baseline to four weeks after beginning of the intervention.
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 21 Jan 2026.
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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.
Nahed Salem, professor study director
Cairo 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 multi-sensory Rehabilition and selected traditional physical therapy program. in people with Stroke and Ischemic, run by Cairo 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 6 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 21 Jan 2026. 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. Some participants in this study may receive a placebo. 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?
Fugl-Meyer Assessment for upper extremity (FMT-UE). (time frame: from baseline to four weeks after the beginning of intervention). 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 21 Jan 2026.