Effects of Orofacial Myofunctional Therapy on Mental Functioning and Overall Self-Sufficiency in Stroke Patients

Study Overview
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Brief Summary
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This project will explore the effects of orofacial myofunctional therapy on mental functioning and overall self-sufficiency in stroke patients. The population sample will be 70 divided randomly into two groups by concealed envelop method. Then i will collect data from Physiotherapy department Wapda Hospital complex, Lahore. Group A will be treated with routine physical therapy treatment that will include EMS, Infrared and Intermittent stretching of facial muscles for 36 sessions on alternate days, each session comprise 30 minutes . Group B will receive routine physical therapy along with orofacial therapy (36 sessions on alternate days, each session comprise 45 minutes) .

Detailed Description
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This project will explore the effects of orofacial myofunctional therapy on mental functioning and overall self-sufficiency in stroke patients. The population sample will be 70 divided randomly into two groups by concealed envelop method. Then i will collect data from Physiotherapy department Wapda Hospital complex, Lahore. Group A will be treated with routine physical therapy treatment that will include EMS, Infrared and Intermittent stretching of facial muscles for 36 sessions on alternate days, each session comprise 30 minutes . Group B will receive routine physical therapy along with orofacial therapy (36 sessions on alternate days, each session comprise 45 minutes) .According to the treatment protocol, the patients participated of the OMT sessions, lasting 45 minutes each, with a weekly frequency during the first 30 days and every two weeks after this period, with no other additional therapeutic conducts5 (treatment duration = 120 days). A home exercise program was pre- scribed during each session. 10 personal activities: feeding, personal toileting, bathing, dressing and undressing, getting on and off a toilet, controlling bladder, controlling bowel, moving from wheelchair to bed and returning, walking on level surface (or propelling a wheelchair if unable to walk) and ascending and descending stairs.

Official Title
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Effects of Orofacial Myofunctional Therapy on Mental Functioning and Overall Self-Sufficiency in Stroke Patients: A Randomized Controlled Trial

Conditions
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Stroke

Intervention / Treatment
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* Other: Routine physical therapy treatment
* Other: Routine physical therapy along with orofacial therapy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Both Gender Age (Years) 40-70 Subacute stage of a strok Exclusion Criteria: - Trauma (e.g., temporal bone fracture) Infection Herpes zoster (Ramsay Hunt syndrome) Borreliosis (Lyme disease) HSV reactivation HIV Tumors (esp. parotid gland tumors) Pregnancy Diabetes mellitus Guillain-Barré syndrome Sarcoidosis Amyloidosis Stroke

Ages Eligible for Study
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Minimum Age: 40 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Group A<br>Routine physical therapy treatment | Other: Routine physical therapy treatment<br>* Control group will receive the routine physical therapy treatment that will include EMS, Infrared and Intermittent stretching of facial muscles for 36 sessions on alternate days, each session comprise 30 minutes for 5 days a week<br>|
| Experimental: Group B:<br>Routine physical therapy along with orofacial therapy | Other: Routine physical therapy along with orofacial therapy<br>* Experimental group will receive routine physical therapy along with orofacial therapy (36 sessions on alternate days, each session comprise 45 minutes)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mental Functioning: | Mental Functioning will be evaluated according to the beck depression inventory. Add up the score for each of the twenty-one questions by counting the number to the right of each question you marked. The highest possible total for the whole test would be sixty-three. This would mean you circled number three on all twenty-one questions. Since the lowest possible score for each question is zero, the lowest possible score for the test would be zero. This would mean you circles zero on each question. Levels of Depression scoring criteria: 1-10 (These ups and downs are considered normal) 11-16 (Mild mood disturbance) 17-20 (Borderline clinical depression) 21-30 (Moderate depression) 31-40 (Severe depression) over 40 (Extreme depression) | 120 days | 
| Overall self-sufficiency | Overallself-sufficiency will be assessed via questionnaire by barthel with determination of barthel index23. The Barthel Scale/Index is an ordinal scale used to measure performance in activities of daily living . Ten variables describing ADL and mobility are scored, a higher number being a reflection of greater ability to function independently following hospital discharge.Time taken and physical assistance required to perform each item are used in determining the assigned value of each item. The Barthel Index measures the degree of assistance required by an individual on 10 items of mobility and self care ADL. The Barthel includes 10 personal activities: feeding, personal toileting, bathing, dressing and undressing, getting on and off a toilet, controlling bladder, controlling bowel, moving from wheelchair to bed and returning, walking on level surface (or propelling a wheelchair if unable to walk) and ascending and descending stairs. | 120 days |