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

Stroke Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05061043
• Other study ID #: IRB-UOL-FAHS/892/2021
• Status: Recruiting
• Phase: N/A
• Start date: July 1, 2021
• Est. completion date: December 28, 2021

Study information

• Verified date: July 2021
• Source: University of Lahore
• Contact: MANAHIL ZARAR, MS
• Phone: 03244250061
• Email: manahilzrar52[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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) .

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 70
• Est. completion date: December 28, 2021
• Est. primary completion date: December 1, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Stroke

Intervention

Other:
• Routine physical therapy treatment
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
• Routine physical therapy along with orofacial therapy
Experimental group will receive routine physical therapy along with orofacial therapy (36 sessions on alternate days, each session comprise 45 minutes)

Locations

Country	Name	City	State
Pakistan	Physiotherapy department Wapda Hospital complex, Lahore	Lahore	Punjab

Sponsors (1)

Lead Sponsor	Collaborator
University of Lahore

Country where clinical trial is conducted

Pakistan, 

References & Publications (4)

Hohman MH, Hadlock TA. Etiology, diagnosis, and management of facial palsy: 2000 patients at a facial nerve center. Laryngoscope. 2014 Jul;124(7):E283-93. doi: 10.1002/lary.24542. Epub 2014 Jan 15. — View Citation

Konecny P, Elfmark M, Urbanek K. Facial paresis after stroke and its impact on patients' facial movement and mental status. J Rehabil Med. 2011 Jan;43(1):73-5. doi: 10.2340/16501977-0645. — View Citation

Swider K, Matys J. Complete dentures for a patient after a stroke by means of orofacial myofunctional therapy: A clinical report. J Prosthet Dent. 2018 Aug;120(2):177-180. doi: 10.1016/j.prosdent.2017.10.023. Epub 2018 Mar 16. — View Citation

Vaughan A, Gardner D, Miles A, Copley A, Wenke R, Coulson S. A Systematic Review of Physical Rehabilitation of Facial Palsy. Front Neurol. 2020 Mar 31;11:222. doi: 10.3389/fneur.2020.00222. eCollection 2020. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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