NCT06976814

Brief Summary

The Primary objective of the study is to investigate the most effective treatment modalities available to speech language pathologist as well as movement difference by comparing them.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Apr 2021

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 19, 2021

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 29, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 29, 2022

Completed
2.8 years until next milestone

First Submitted

Initial submission to the registry

April 15, 2025

Completed
1 month until next milestone

First Posted

Study publicly available on registry

May 16, 2025

Completed
Last Updated

May 16, 2025

Status Verified

May 1, 2025

Enrollment Period

1.2 years

First QC Date

April 15, 2025

Last Update Submit

May 15, 2025

Conditions

Outcome Measures

Primary Outcomes (1)

  • Sunnybrook Facial Grading System

    Upon enrollment Sunnybrook is given as baseline. The minimum score a patient may score is 20 out of 100. The higher the score the better (means patient has minor facial asymmetry). Each participant/patient was planned for 30sessions. Baseline score was recorded and beginning of each week Sunnybrook was given and new score was recorded by the same clinician.

    Patients were enrolled for 30sessions as per the protocol. Participants were given 5 sessions in a week. Patients were assessed as baseline upon enrollment into the study and re-assessed beginning of each week.

Study Arms (3)

Neuro muscular electrical stimulation arm

EXPERIMENTAL
Other: Neuro muscular electrical stimulation

Beckmann Oral Motor Exercise Arm

EXPERIMENTAL
Other: Beckmann's oral motor exercises

Neuro Muscular Electrical Stimulation Arm + Beckmann Oral Motor Exercise Arm

EXPERIMENTAL
Other: Neuro muscular electrical stimulationOther: Beckmann's oral motor exercises

Interventions

electrical stimulation to facial nerve to improve facial palsy

Neuro Muscular Electrical Stimulation Arm + Beckmann Oral Motor Exercise ArmNeuro muscular electrical stimulation arm

Oral motor exercises to improve facial palsy.

Beckmann Oral Motor Exercise ArmNeuro Muscular Electrical Stimulation Arm + Beckmann Oral Motor Exercise Arm

Eligibility Criteria

Age20 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients with 1st stroke
  • Hemorrhagic stroke
  • Ischemic stroke
  • Right hemispheric stroke
  • Left hemispheric stroke
  • Normal cognitive skills (Based on Montreal cognitive assessment MOCA)
  • Normal Language (Not Aphasic)
  • Normal swallowing

You may not qualify if:

  • Patients with Bell's palsy
  • Facial trauma
  • Post otitis media surgeries
  • Neoplasm, malignant or tumor cell invasion of facial nerve
  • Cognitive impairment
  • Patients with aphasia
  • Patients on defibrillator cardiac devices
  • Patients with pacemakers or any other type of cardiac devices
  • Multiple strokes

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hamad Medical Corporation

Doha, Qatar, 3050, Qatar

Location

MeSH Terms

Conditions

Facial Paralysis

Condition Hierarchy (Ancestors)

Mouth DiseasesStomatognathic DiseasesParalysisNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director of Rehabilitation

Study Record Dates

First Submitted

April 15, 2025

First Posted

May 16, 2025

Study Start

April 19, 2021

Primary Completion

June 29, 2022

Study Completion

June 29, 2022

Last Updated

May 16, 2025

Record last verified: 2025-05

Data Sharing

IPD Sharing
Will not share

Patient privacy

Locations