StrokeNCT05485740
Cognitive Multisensory on Upper Extremity in Stroke
A study testing cognitive multisensory rehabilitation and the selected exercise program in people with Stroke, run by October 6 University at 1 site in Egypt.
Trial summary
PURPOSE: To investigate the effect of cognitive multisensory rehabilitation program on upper extremity function in stroke patients. BACKGROUND: Cognitive Multisensory Rehabilitation (CMR) is a promising therapy for upper limb recovery in stroke, as the CMR considered an effective therapy for motor recovery for adults… Read more about this study
- Who is it for?
- Ages 45 to 60 years
- Conditions the study is for
- Stroke
- What is being tested?
- cognitive multisensory rehabilitation and the selected exercise program
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Aug 2022to 30 Dec 2022
- 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
- Thirty hemiplegic patients, with the onset of stroke six months or longer.
- Both sexes, with ages ranging from 45: 60.
- Body mass index will range from 18.5-to 29.9 Kg/m2.
Who cannot join
- Other brain injuries/illnesses, cognitive impairment, severe sensory or proprioceptive loss.
- Other causes of hemiplegia.
- Other causes of upper extremity dysfunction.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Cognitive Multisensory Rehabilitation on Upper Extremity Function in Stroke Patients
PURPOSE:
To investigate the effect of cognitive multisensory rehabilitation program on upper extremity function in stroke patients.
BACKGROUND: Cognitive Multisensory Rehabilitation (CMR) is a promising therapy for upper limb recovery in stroke, as the CMR considered an effective therapy for motor recovery for adults with stroke
Read the detailed description
Thirty patients with stroke The patients will randomly be divided into two equal groups; the control group which received the selected exercise program and the study group received the same exercise training program in addition to cognitive multisensory rehabilitation program, three times per week for 2 months. The evaluation methods Action research arm test (ARAT), Fugl-Myer Assessment upper extremity (FMA-UE), manual function test and Motor Evaluation Scale for Upper Extremity
- Conditions
- Stroke
- Being tested
- cognitive multisensory rehabilitation, the selected exercise program
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
cognitive multisensory rehabilitationOther
sensorimotor rehabilitation approach, in which the patient is asked to solve sensory discrimination exercises with closed eyes or to solve multisensory discrimination exercises, e.g., by comparing feeling shapes with seeing shapes.
the selected exercise programOther
Upper Extremity Range of motion (ROM) exercises Passive Prolonged Stretching and positioning Weight-bearing exercise
| Study group | Role | What they receive |
|---|---|---|
| study group | Experimental | the study group received the same exercise training program in addition to cognitive multisensory rehabilitation program Receives: Other: cognitive multisensory rehabilitation; Other: the selected exercise program |
| control group | Experimental | the control group which received the selected exercise program Receives: Other: the selected exercise program |
What is being measured
The primary outcome is the main question the study is designed to answer.
Action research arm test
one of the most commonly used upper limb outcomes that measure the activity level in stroke rehabilitation studies consists of a total of 19 functional materials and four subtests as follows: grasp, grip, pinch, and gross movement
Measured: 8 weeks
Manual function test
is a performance-based assessment for upper limbs with paresis caused by stroke The MFT is graded on a four-level scale. The total MFT score can range from 0 (severely impaired) to 32 (full function)
Measured: 8 weeks
Fugl Myer Assessment upper extremity
is a scale consisting of 30 items assessing motor function and 3 items assessing reflex function The FMA-UE scores of 0 through 22 represent no upper-limb capacity; scores of 23 through 31 represent poor capacity; scores of 32 through 47 represent limited capacity; scores of 48 through 52 represent notable capacity; and scores of 53 through 66 represent full upper-limb capacity, total sensation UE score 12, passive joint motion UE score 24 and UE joint pain scores 24
Measured: 8 weeks
Motor Evaluation Scale for Upper Extremity in Stroke patients
is a scale that measures the quality of movement of the hemiparetic upper extremity The maximum total score for the MESUPES is 58. The MESUPES-arm comprises 8 items of shoulder and elbow performance, with a maximum score of 40. Each item is scored from 0 (inability to adapt muscle tone to the movement) to 5 (ability to correct and complete motion without help)
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 posted3 Aug 2022
- Study start1 Aug 2022
- Primary completion30 Dec 2022
- Study completion30 Dec 2022
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
- the control group which received the selected exercise program and the study group received the same exercise training program in addition to cognitive multisensory rehabilitation program
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- October 6 University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Lama Saad El-Din Mahmoud, October 6 University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05485740
- Sponsor's protocol ID
- P.T. REC/012/003797
- Status last verified
- Feb 2023
- First submitted
- 1 Aug 2022
- Last updated
- 1 Mar 2023
- Results posted
- No
- 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 1 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cognitive Multisensory Rehabilitation on Upper Extremity Function in Stroke Patients
- ClinicalTrials.gov ID
- NCT05485740
- Acronym / sponsor ID
- P.T. REC/012/003797
- Conditions
- Stroke
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- October 6 UniversityUniversity, hospital or other
- Study start
- 1 Aug 2022 (actual)
- Primary completion
- 30 Dec 2022 (actual)
- Study completion
- 30 Dec 2022 (actual)
- First posted
- 3 Aug 2022 (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.
PURPOSE:
To investigate the effect of cognitive multisensory rehabilitation program on upper extremity function in stroke patients.
BACKGROUND: Cognitive Multisensory Rehabilitation (CMR) is a promising therapy for upper limb recovery in stroke, as the CMR considered an effective therapy for motor recovery for adults with stroke
Detailed description
Thirty patients with stroke The patients will randomly be divided into two equal groups; the control group which received the selected exercise program and the study group received the same exercise training program in addition to cognitive multisensory rehabilitation program, three times per week for 2 months. The evaluation methods Action research arm test (ARAT), Fugl-Myer Assessment upper extremity (FMA-UE), manual function test and Motor Evaluation Scale for Upper Extremity
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- the control group which received the selected exercise program and the study group received the same exercise training program in addition to cognitive multisensory rehabilitation program
| Arm | Type | Receives |
|---|---|---|
| study group | Experimental | Other: cognitive multisensory rehabilitation, Other: the selected exercise programthe study group received the same exercise training program in addition to cognitive multisensory rehabilitation program |
| control group | Experimental | Other: the selected exercise programthe control group which received the selected exercise program |
Who may qualify
- Ages
- 45 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Thirty hemiplegic patients, with the onset of stroke six months or longer.
- Both sexes, with ages ranging from 45: 60.
- Body mass index will range from 18.5-to 29.9 Kg/m2.
Key exclusion criteria (3 listed)
- Other brain injuries/illnesses, cognitive impairment, severe sensory or proprioceptive loss.
- Other causes of hemiplegia.
- Other causes of upper extremity dysfunction.
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 multisensory rehabilitationsensorimotor rehabilitation approach, in which the patient is asked to solve sensory discrimination exercises with closed eyes or to solve multisensory discrimination exercises, e.g., by comparing feeling shapes with seeing shapes. | Other | study group |
| the selected exercise programUpper Extremity Range of motion (ROM) exercises Passive Prolonged Stretching and positioning Weight-bearing exercise | Other | control group, study group |
Primary outcome
Action research arm test
Time frame: 8 weeks
one of the most commonly used upper limb outcomes that measure the activity level in stroke rehabilitation studies consists of a total of 19 functional materials and four subtests as follows: grasp, grip, pinch, and gross movement
Manual function test
Time frame: 8 weeks
is a performance-based assessment for upper limbs with paresis caused by stroke The MFT is graded on a four-level scale. The total MFT score can range from 0 (severely impaired) to 32 (full function)
Fugl Myer Assessment upper extremity
Time frame: 8 weeks
is a scale consisting of 30 items assessing motor function and 3 items assessing reflex function The FMA-UE scores of 0 through 22 represent no upper-limb capacity; scores of 23 through 31 represent poor capacity; scores of 32 through 47 represent limited capacity; scores of 48 through 52 represent notable capacity; and scores of 53 through 66 represent full upper-limb capacity, total sensation UE score 12, passive joint motion UE score 24 and UE joint pain scores 24
Motor Evaluation Scale for Upper Extremity in Stroke patients
Time frame: 8 weeks
is a scale that measures the quality of movement of the hemiparetic upper extremity The maximum total score for the MESUPES is 58. The MESUPES-arm comprises 8 items of shoulder and elbow performance, with a maximum score of 40. Each item is scored from 0 (inability to adapt muscle tone to the movement) to 5 (ability to correct and complete motion without help)
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 1 Mar 2023.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
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 multisensory rehabilitation and the selected exercise program in people with Stroke, run by October 6 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 3 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 1 Mar 2023. 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?
Action research arm test (time frame: 8 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 1 Mar 2023.