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

NCT ID: NCT05061043

Last Updated: 2021-09-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

70 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-07-01

Study Completion Date

2021-12-28

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.

Conditions

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Stroke

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants
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.

Study Groups

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Group A

Routine physical therapy treatment

Group Type ACTIVE_COMPARATOR

Routine physical therapy treatment

Intervention Type 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 B:

Routine physical therapy along with orofacial therapy

Group Type EXPERIMENTAL

Routine physical therapy along with orofacial therapy

Intervention Type OTHER

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

Interventions

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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

Intervention Type OTHER

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)

Intervention Type OTHER

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
Minimum Eligible Age

40 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Lahore

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Manahil zarar, MS

Role: PRINCIPAL_INVESTIGATOR

University of Lahore

Locations

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Physiotherapy department Wapda Hospital complex, Lahore

Lahore, Punjab Province, Pakistan

Site Status RECRUITING

Countries

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Pakistan

Central Contacts

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MANAHIL ZARAR, MS

Role: CONTACT

03244250061

Janat zarar

Role: CONTACT

03224947914

References

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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.

Reference Type BACKGROUND
PMID: 21174055 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 29551384 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 32296385 (View on PubMed)

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.

Reference Type RESULT
PMID: 24431233 (View on PubMed)

Other Identifiers

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IRB-UOL-FAHS/892/2021

Identifier Type: -

Identifier Source: org_study_id

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