NCT05485740

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at P25-P50 for not_applicable stroke

Timeline
Completed

Started Aug 2022

Shorter than P25 for not_applicable stroke

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 1, 2022

Completed
Same day until next milestone

Study Start

First participant enrolled

August 1, 2022

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 3, 2022

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 30, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2022

Completed
Last Updated

March 1, 2023

Status Verified

February 1, 2023

Enrollment Period

5 months

First QC Date

August 1, 2022

Last Update Submit

February 27, 2023

Conditions

Outcome Measures

Primary Outcomes (4)

  • 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

  • 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

  • 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

  • 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

Study Arms (2)

study group

EXPERIMENTAL

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

Other: cognitive multisensory rehabilitationOther: the selected exercise program

control group

EXPERIMENTAL

the control group which received the selected exercise program

Other: the selected exercise program

Interventions

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.

study group

Upper Extremity Range of motion (ROM) exercises Passive Prolonged Stretching and positioning Weight-bearing exercise

control groupstudy group

Eligibility Criteria

Age45 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • Other brain injuries/illnesses, cognitive impairment, severe sensory or proprioceptive loss.
  • Other causes of hemiplegia.
  • Other causes of upper extremity dysfunction.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Lama S Mahmoud

Al Jīzah, Select State, Egypt

Location

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: 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
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Lecturer of physical therapy, Department of Neuromuscular disorders and its surgery, faculty of physical therapy, october 6 univerisity

Study Record Dates

First Submitted

August 1, 2022

First Posted

August 3, 2022

Study Start

August 1, 2022

Primary Completion

December 30, 2022

Study Completion

December 30, 2022

Last Updated

March 1, 2023

Record last verified: 2023-02

Data Sharing

IPD Sharing
Will not share

Locations