- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05485740
Cognitive Multisensory on Upper Extremity in Stroke
February 27, 2023 updated by: Lama Saad El-Din Mahmoud, October 6 University
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
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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 Type
Interventional
Enrollment (Actual)
30
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Select State
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Al Jīzah, Select State, Egypt
- Lama S Mahmoud
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
45 years to 60 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- Other brain injuries/illnesses, cognitive impairment, severe sensory or proprioceptive loss.
- Other causes of hemiplegia.
- Other causes of upper extremity dysfunction.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: study group
the study group received the same exercise training program in addition to cognitive multisensory rehabilitation program
|
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.
Upper Extremity Range of motion (ROM) exercises Passive Prolonged Stretching and positioning Weight-bearing exercise
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Experimental: control group
the control group which received the selected exercise program
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Upper Extremity Range of motion (ROM) exercises Passive Prolonged Stretching and positioning Weight-bearing exercise
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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
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8 weeks
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Manual function test
Time Frame: 8 weeks
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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)
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8 weeks
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Fugl Myer Assessment upper extremity
Time Frame: 8 weeks
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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
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8 weeks
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Motor Evaluation Scale for Upper Extremity in Stroke patients
Time Frame: 8 weeks
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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)
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8 weeks
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
August 1, 2022
Primary Completion (Actual)
December 30, 2022
Study Completion (Actual)
December 30, 2022
Study Registration Dates
First Submitted
August 1, 2022
First Submitted That Met QC Criteria
August 1, 2022
First Posted (Actual)
August 3, 2022
Study Record Updates
Last Update Posted (Actual)
March 1, 2023
Last Update Submitted That Met QC Criteria
February 27, 2023
Last Verified
February 1, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- P.T. REC/012/003797
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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