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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05485740
Other study ID # P.T. REC/012/003797
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date August 1, 2022
Est. completion date December 30, 2022

Study information

Verified date February 2023
Source October 6 University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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 with stroke


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


Recruitment information / eligibility

Status Completed
Enrollment 30
Est. completion date December 30, 2022
Est. primary completion date December 30, 2022
Accepts healthy volunteers No
Gender All
Age group 45 Years to 60 Years
Eligibility Inclusion Criteria: 1. Thirty hemiplegic patients, with the onset of stroke six months or longer. 2. Both sexes, with ages ranging from 45: 60. 3. Body mass index will range from 18.5-to 29.9 Kg/m2. Exclusion Criteria: 1. Other brain injuries/illnesses, cognitive impairment, severe sensory or proprioceptive loss. 2. Other causes of hemiplegia. 3. Other causes of upper extremity dysfunction.

Study Design


Related Conditions & MeSH terms


Intervention

Other:
cognitive multisensory rehabilitation
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 program
Upper Extremity Range of motion (ROM) exercises Passive Prolonged Stretching and positioning Weight-bearing exercise

Locations

Country Name City State
Egypt Lama S Mahmoud Al Jizah Select State

Sponsors (1)

Lead Sponsor Collaborator
October 6 University

Country where clinical trial is conducted

Egypt, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 8 weeks
Primary 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) 8 weeks
Primary 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 8 weeks
Primary 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) 8 weeks
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