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

NCT05061043 | Unknown DMC

• 1 other identifier: IRB-UOL-FAHS/892/2021
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

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) .

Conditions

Stroke

Outcome Measures

Primary Outcomes (2)

• 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

Study Arms (2)

Group A

ACTIVE COMPARATOR

Routine physical therapy treatment

Other: Routine physical therapy treatment

Group B:

EXPERIMENTAL

Routine physical therapy along with orofacial therapy

Other: Routine physical therapy along with orofacial therapy

Interventions

Routine physical therapy treatment OTHER

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

Group A

Routine physical therapy along with orofacial therapy OTHER

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

Group B:

Eligibility Criteria

• Age: 40 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Both Gender
• Age (Years) 40-70
• Subacute stage of a strok

You may not qualify if:

• \- 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

Sponsors & Collaborators

• University of Lahore: lead

Study Sites (1)

Physiotherapy department Wapda Hospital complex, Lahore

Lahore, Punjab Province, 54770, Pakistan

RECRUITING

Related Publications (4)

• 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.

  PMID: 21174055 BACKGROUND

• 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.

  PMID: 29551384 BACKGROUND

• 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.

  PMID: 32296385 BACKGROUND

• 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.

  PMID: 24431233 RESULT

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Manahil zarar, MS

  University of Lahore

  PRINCIPAL INVESTIGATOR

Central Study Contacts

MANAHIL ZARAR, MS

CONTACT

03244250061; manahilzrar52@gmail.com

Janat zarar

CONTACT

03224947914; manahilzrar52@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: The study was single blinded in which subjects were managed to be masked of treatment options available for other groups. Clinicians and assessors could not be blinded due to apparently very different procedures of two groups.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 18, 2021
• First Posted: September 29, 2021
• Study Start: July 1, 2021
• Primary Completion: December 1, 2021
• Study Completion: December 28, 2021
• Last Updated: September 29, 2021

Record last verified: 2021-07

Locations

PA (1)