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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05544747
Other study ID # REC-01332 Sania
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date October 1, 2022
Est. completion date March 1, 2023

Study information

Verified date December 2022
Source Riphah International University
Contact Sania Syed, MS NMPT*
Phone +92 321 1930855
Email saniasyed48@gmail.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Stroke is a medical condition which causes the cessation of blood flow to the brain cells and results in cell death and ultimately can lead to motor disorders, perception disorders, language disorders, sensory disturbances.It is well known that stroke is the leading cause of death and one of the greatest causes of long-term motor disability in adults.The incidence of stroke is increasing day by day in low-income countries as compared to high-income countries because of the effects of not using evidence-based practice in health-related conditions in low-income countries. In the last few years, several approaches have been used for the recovery of hand dexterity after stroke. Among them, the Mirror therapy, task-oriented therapy, robot-assisted rehabilitation and action observation has gained greatest attention.Action observation training is one of the new developing rehabilitation technique that targets motor learning by the activation of mirror neurons and is the most important approach that targets the motor and functional recovery in stroke patients. In action observation training, the movements are produced because of the external stimuli in which actually the visual attention recruit the cerebellar-thalamic-cortical circuit of the brain. Action observation is based on activities of the motor neuron system and they discharge mostly in association with complex tasks as compared to simple tasks.


Recruitment information / eligibility

Status Recruiting
Enrollment 50
Est. completion date March 1, 2023
Est. primary completion date March 1, 2023
Accepts healthy volunteers No
Gender All
Age group 40 Years to 60 Years
Eligibility Inclusion Criteria: - Both male and female - Middle cerebral artery stroke - 1 to 6 months of stroke onset - Baseline score of the Fugyl Myer Assessment is between 20 and 60 for the upper limb. - Modified Ashworth scale with a score of 2 Ability to follow the study instructions-Mini mental state examination (MMSE) score >25 Exclusion Criteria: - Participants failing to fall in this category would be excluded from the study. - Patients who cannot perform the active movement of the upper limb in pre-stroke condition due to musculoskeletal problems - cardiopulmonary diseases which could hinder their ability to participate in the rehabilitation program in this study - Patient with impaired cognition

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Action Observation Therapy
following phases will be included in action observation therapy group: upper limb active range of motion (AROM) exercises. reaching movement or object manipulation. upper limb functional tasks.
Mirror Therapy
following phases will be included in mirror therapy group: AROM exercises), reaching movement or object manipulation, and functional task practice

Locations

Country Name City State
Pakistan Helping hand institute of rehabilitation sciences Mansehra

Sponsors (1)

Lead Sponsor Collaborator
Riphah International University

Country where clinical trial is conducted

Pakistan, 

Outcome

Type Measure Description Time frame Safety issue
Primary Fugel Meyer assessment scale for upper limb An assessment scale for post stroke hemiplegic patients and is performance-based impairment index. This scale is having 5 domains namely Motor functioning, Sensory Functioning, Balance, Joint Range of Motion and Joint pain. I divided the motor functioning for upper extremity into 0 to 66 points and evaluates mobility, speed and coordination week 6
Primary Box and Block Test (BBT) This test is used to evaluate the manual dexterity of post stroke patients. BBT is composed of wooden box with two equal compartments having 150 boxes in one compartment and patient is asked to move the boxes from one compartment to another within 60 seconds. Before starting the test an extra 15 seconds time is given to the patient for familiarization with the test. First the patient performed the activity with the healthy arm and then with the affected arm. Scoring is done on the basis of the number of boxes transferred from one compartment to another within 60 seconds week 6
Primary Functional Independence Measure (FIM) The FIM is a commonly used scale for assessing the performance in basic daily activities. It contains 18 items (i.e., 13 motor and 5 cognition items), and the total score ranges from 0 to 126 week 6
Secondary Stroke Impact Scale (SIS) version 3.0 The SIS 3.0 is a stroke-specific, patient-reported questionnaire for evaluating the function, participation, and health-related quality of life of stroke survivors. The SIS 3.0 has sound psychometric properties. It consists of 59 items, and higher scores indicate better function and greater participation. week 6
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