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Cognitive Multisensory on Upper Extremity in Stroke

Primary Purpose

Stroke

Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
cognitive multisensory rehabilitation
the selected exercise program
Sponsored by
October 6 University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Stroke

Eligibility Criteria

45 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Lama S Mahmoud

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

study group

control group

Arm Description

the study group received the same exercise training program in addition to cognitive multisensory rehabilitation program

the control group which received the selected exercise program

Outcomes

Primary Outcome Measures

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
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)
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
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)

Secondary Outcome Measures

Full Information

First Posted
August 1, 2022
Last Updated
February 27, 2023
Sponsor
October 6 University
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1. Study Identification

Unique Protocol Identification Number
NCT05485740
Brief Title
Cognitive Multisensory on Upper Extremity in Stroke
Official Title
Cognitive Multisensory Rehabilitation on Upper Extremity Function in Stroke Patients
Study Type
Interventional

2. Study Status

Record Verification Date
February 2023
Overall Recruitment Status
Completed
Study Start Date
August 1, 2022 (Actual)
Primary Completion Date
December 30, 2022 (Actual)
Study Completion Date
December 30, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
October 6 University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief 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
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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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)
Allocation
Randomized
Enrollment
30 (Actual)

8. Arms, Groups, and Interventions

Arm Title
study group
Arm Type
Experimental
Arm Description
the study group received the same exercise training program in addition to cognitive multisensory rehabilitation program
Arm Title
control group
Arm Type
Experimental
Arm Description
the control group which received the selected exercise program
Intervention Type
Other
Intervention Name(s)
cognitive multisensory rehabilitation
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
the selected exercise program
Intervention Description
Upper Extremity Range of motion (ROM) exercises Passive Prolonged Stretching and positioning Weight-bearing exercise
Primary Outcome Measure Information:
Title
Action research arm test
Description
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
Time Frame
8 weeks
Title
Manual function test
Description
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)
Time Frame
8 weeks
Title
Fugl Myer Assessment upper extremity
Description
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
Time Frame
8 weeks
Title
Motor Evaluation Scale for Upper Extremity in Stroke patients
Description
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)
Time Frame
8 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
45 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Facility Information:
Facility Name
Lama S Mahmoud
City
Al Jīzah
State/Province
Select State
Country
Egypt

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Cognitive Multisensory on Upper Extremity in Stroke

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