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

Not Applicable

• Conditions: Stroke
• Interventions: Other: Routine physical therapy treatment; Other: Routine physical therapy along with orofacial therapy

• Registration Number: NCT05061043
• Lead Sponsor: University of Lahore

Brief Summary

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

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.

Study Timeline

• Status Verified: 2021-07
• Study Start: 2021-07-01
• Study First Submitted: 2021-09-18
• Study First Submitted QC: 2021-09-18
• Last Update Submitted: 2021-09-18
• Study First Posted: 2021-09-29
• Last Update Posted: 2021-09-29
• Primary Completion: 2021-12-01
• Study Completion: 2021-12-28

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 70

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group A	Routine physical therapy treatment	Routine physical therapy treatment
Group B:	Routine physical therapy along with orofacial therapy	Routine physical therapy along with orofacial therapy

Primary Outcome Measures

Name	Time	Method
Overall self-sufficiency	120 days	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.
Mental Functioning:	120 days	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)

Trial Locations

Locations (1)

Physiotherapy department Wapda Hospital complex, Lahore; 🇵🇰 Lahore, Punjab, Pakistan