Clinical trial NCT05061043: Effects of Orofacial Myofunctional Therapy on Mental Functioning and Overall Self-Sufficiency in Stroke Patients
Official title: Effects of Orofacial Myofunctional Therapy on Mental Functioning and Overall Self-Sufficiency in Stroke Patients: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Stroke
Lead sponsor: University of Lahore
Sponsor class: OTHER
First posted: 2021-09-29
Enrollment: 70
Sex: ALL
Minimum age (years): 40
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Mental Functioning:
timeFrame: 120 days
measure: Overall self-sufficiency
timeFrame: 120 days
Secondary outcomes:
Other outcomes:
Locations:
city: Lahore
country: Pakistan
facility: Physiotherapy department Wapda Hospital complex, Lahore
state: Punjab
Study officials:
affiliation: University of Lahore
name: Manahil zarar, MS
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.
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.
citation: 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.