Cognitive Multisensory on Upper Extremity in Stroke

• Sponsor: October 6 University (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT05485740
• Collaborator: (none)
• Enrollment: 30
• Location: 1
• Arms: 2
• Anticipated Duration (Months): 4
• Patients Per Site Per Month: 7.5

Study Details

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

Condition or Disease	Intervention/Treatment	Phase
Stroke	Other: cognitive multisensory rehabilitation; Other: the selected exercise program	N/A

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

• Study Type: Interventional
• Anticipated Enrollment: 30 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Intervention 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 programthe 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)
• Primary Purpose: Treatment
• Official Title: Cognitive Multisensory Rehabilitation on Upper Extremity Function in Stroke Patients
• Actual Study Start Date: Aug 1, 2022
• Anticipated Primary Completion Date: Nov 15, 2022
• Anticipated Study Completion Date: Nov 30, 2022

Arms and Interventions

Arm	Intervention/Treatment
Experimental: study group the study group received the same exercise training program in addition to cognitive multisensory rehabilitation program	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.; Other: the selected exercise program; Upper Extremity Range of motion (ROM) exercises Passive Prolonged Stretching and positioning Weight-bearing exercise
Experimental: control group the control group which received the selected exercise program	Other: the selected exercise program; Upper Extremity Range of motion (ROM) exercises Passive Prolonged Stretching and positioning Weight-bearing exercise

Outcome Measures

Primary Outcome Measures

1. Action research arm test [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

2. Manual function test [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)

3. Fugl Myer Assessment upper extremity [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

4. Motor Evaluation Scale for Upper Extremity in Stroke patients [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)

Eligibility Criteria

Criteria

• Ages Eligible for Study: 45 Years to 60 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Lama S Mahmoud	Al Jīzah	Select State	Egypt

Sponsors and Collaborators

• October 6 University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Lama Saad El-Din Mahmoud, Lecturer of physical therapy, Department of Neuromuscular disorders and its surgery, faculty of physical therapy, october 6 univerisity, October 6 University
• ClinicalTrials.gov Identifier: NCT05485740
• Other Study ID Numbers: P.T. REC/012/003797
• First Posted: Aug 3, 2022
• Last Update Posted: Aug 10, 2022
• Last Verified: Aug 1, 2022

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Stroke

Study Results

No Results Posted as of Aug 10, 2022