NCT07568769

Brief Summary

Stroke is a leading cause of long-term disability worldwide and frequently results in central facial palsy, which manifests as facial asymmetry, impaired muscle control, and reduced functional ability. These impairments can affect speech, emotional expression, and overall quality of life. Conventional physiotherapy is commonly used to manage post-stroke facial palsy; however, the additional benefit of sensory-based rehabilitation approaches remains insufficiently explored, particularly in clinical settings with limited resources. This study was conducted to evaluate whether the addition of exteroceptive stimulation to conventional physiotherapy leads to greater improvement in facial symmetry and functional outcomes compared to conventional physiotherapy alone. Exteroceptive stimulation aims to enhance sensory input and facilitate neuromuscular activation, potentially improving motor recovery in affected facial muscles. In this double-blind randomized controlled trial, a total of 36 participants diagnosed with post-stroke facial palsy were recruited and randomly allocated into two groups. The experimental group received exteroceptive stimulation in addition to conventional physiotherapy, while the control group received conventional physiotherapy alone. Both interventions were administered over a period of four weeks. Outcome measures were assessed at baseline and at the end of the intervention period. The primary outcome was lip angle deviation, used as an indicator of facial symmetry. Secondary outcomes included facial function and disability assessed using standardized tools such as the Facial Disability Index and the Synkinesis Assessment Questionnaire. The findings of this study aim to provide evidence on the effectiveness of integrating sensory-based techniques into routine rehabilitation programs for post-stroke facial palsy. The results may support the development of more comprehensive and effective rehabilitation strategies to improve patient outcomes.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
36

participants targeted

Target at P25-P50 for not_applicable stroke

Timeline
Completed

Started Aug 2025

Shorter than P25 for not_applicable stroke

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

August 1, 2025

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 24, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 24, 2025

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

April 28, 2026

Completed
8 days until next milestone

First Posted

Study publicly available on registry

May 6, 2026

Completed
Last Updated

May 6, 2026

Status Verified

April 1, 2026

Enrollment Period

5 months

First QC Date

April 28, 2026

Last Update Submit

April 28, 2026

Conditions

Keywords

Stroke Rehabilitation; Facial Paralysis; Exteroceptive Stimulation; Neurorehabilitation; Synkinesis

Outcome Measures

Primary Outcomes (1)

  • Change in Lip Angle Deviation

    Lip angle deviation was measured using standardized facial symmetry assessment techniques to evaluate improvement in facial alignment.

    Baseline and Week 4

Secondary Outcomes (2)

  • Facial Disability Index (FDI)

    Baseline and Week 4

  • Synkinesis Assessment Questionnaire (SAQ)

    Baseline and Week 4

Study Arms (2)

Exteroceptive Stimulation

EXPERIMENTAL

Exteroceptive stimulation was applied to the affected side of the face using structured sensory techniques, including light touch, stroking, tapping, and graded pressure over the perioral, cheek, and nasolabial regions. The intervention was delivered by a trained physiotherapist in a standardized sequence to enhance sensory input and facilitate neuromuscular activation.

Other: Exteroceptive StimulationOther: Conventional Physiotherapy

Conventional Physiotherapy

ACTIVE COMPARATOR

Conventional physiotherapy included a structured facial rehabilitation program comprising facial muscle exercises, facilitation techniques, and functional retraining aimed at improving symmetry and muscle coordination.

Other: Conventional Physiotherapy

Interventions

Exteroceptive stimulation was applied to the affected side of the face using structured sensory techniques, including light touch, stroking, tapping, and graded pressure over the perioral, cheek, and nasolabial regions. The intervention was delivered by a trained physiotherapist in a standardized sequence to enhance sensory input and facilitate neuromuscular activation. Each session lasted approximately 30-40 minutes and was administered 5 days per week for 4 weeks in a clinical setting. This intervention was provided in combination with conventional physiotherapy.

Exteroceptive Stimulation

Conventional physiotherapy included a structured facial rehabilitation program comprising facial muscle exercises, facilitation techniques, and functional retraining to improve symmetry and coordination. Sessions were delivered by a qualified physiotherapist, lasting approximately 30-40 minutes, 5 days per week for 4 weeks. This intervention was provided alone in the control group and in combination with exteroceptive stimulation in the experimental group.

Conventional PhysiotherapyExteroceptive Stimulation

Eligibility Criteria

Age40 Years - 55 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Patients diagnosed with post-stroke facial palsy Age between 40 and 55 years Both male and female participants Acute onset of facial weakness within 1-3 weeks Non-traumatic onset of disease Commitment to comply with electrical stimulation treatment for 2 months, were included in this study.

You may not qualify if:

  • Participation in other therapies for facial nerve, Presence of neoplastic tumor, Pregnancy, Cardiac, Excessive perspiration, Psychiatric illness or Mental impairment, Neurotmesis, Post-surgical cases of heart and brain surgery, Bilateral facial palsy due to demyelinating disease e.g. motor neuron disease, trigeminal neuralgia, Open wounds/ulcers, ENT impairment/Otitis Media, Repetitive previous history of stroke, Invasive cardiac instrumentation such as endarterectomy or stent placement within 30 days prior to admission in ICU were excluded

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Tertiary Care Hospitals, Faisalabad, Pakistan

Faisalābad, Punjab Province, 3800, Pakistan

Location

Related Publications (1)

  • 1. Albaret G, Domergue H. Stroke and stroke rehabilitation. Pathy's Princ Pract Geriatr Med. Published online February 18, 2022:619-634. doi:10.1002/9781119484288.CH48 2. Unnithan AKA, Das JM, Mehta P. Hemorrhagic Stroke. In Statpearls. Published online December 13, 2025:1-12. 3. Fulk GD., Chui KK. O'Sullivan & Schmitz's physical rehabilitation. Published online 2024:1337. 4. Choi JH, Kim BR, Han EY, Kim SM. The Effect of Dual-Task Training on Balance and Cognition in Patients With Subacute Post-Stroke. Ann Rehabil Med. 2015;39(1):81. doi:10.5535/ARM.2015.39.1.81 5. Junior VA dos S, Santos M de S, Ribeiro NM da S, Maldonado IL. Combining Proprioceptive Neuromuscular Facilitation and Virtual Reality for Improving Sensorimotor Function in Stroke Survivors: A Randomized Clinical Trial. J Cent Nerv Syst Dis. 2019;11. doi:10.1177/1179573519863826 6. Hashmi M, Khan M, Wasay M. Growing Burden of Stroke in Pakistan: A Review of Progress and Limitations. Int J Stroke. 2013;8(7):575-581. doi:10.1111/J.1747-4949.2012.00827.X 7. Schimmel M, Voegeli G, Duvernay E, Leemann B, Müller F. Oral tactile sensitivity and masticatory performance are impaired in stroke patients. J Oral Rehabil. 2017;44(3):163-171. doi:10.1111/JOOR.12482 8. Schimmel M, Ono T, Lam OLT, Müller F. Oro-facial impairment in stroke patients. J Oral Rehabil. 2017;44(4):313-326. doi:10.1111/JOOR.12486 9. Johal A, Dunne B, Bolooki H, Sandler C. Oral Health-Related Quality of Life (OHRQoL), Pain and Side Effects in Adults Undergoing Different Orthodontic Treatment Modalities: A Systematic Review and Meta-Analysis. Healthc 2025, Vol 13,. 2025;13(24). doi:10.3390/HEALTHCARE13243317 10. Taj F, Zahid R, Syeda UER, Murtaza M, Ahmed S, Kamal AK. Risk Factors of Stroke in Pakistan: A Dedicated Stroke Clinic Experience. Can J Neurol Sci. 2010;37(2):252-257. doi:10.1017/S0317167100010015 11. Walcott BP, Miller JC, Kwon CS, et al. Outcomes in severe middle cerebral artery ischemic stroke. Neurocrit Care. 2014;21(1)

    BACKGROUND

MeSH Terms

Conditions

StrokeFacial ParalysisSynkinesis

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular DiseasesMouth DiseasesStomatognathic DiseasesParalysisNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsDyskinesias

Study Officials

  • Dr Muhammad Ateeb, PhD Public Health

    Research Associate, The University of Faisalabad, Faisalabad 38000, Pakistan

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: This study followed a parallel-group randomized controlled design in which participants were allocated to one of two groups and remained in that group for the duration of the study. Both groups received conventional physiotherapy as standard care, while the experimental group received additional exteroceptive stimulation. Interventions were delivered concurrently over a four-week period, and outcomes were assessed at baseline and after completion of the intervention. No crossover between groups occurred.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate professor/ Head Department of Rehabilitation sciences

Study Record Dates

First Submitted

April 28, 2026

First Posted

May 6, 2026

Study Start

August 1, 2025

Primary Completion

December 24, 2025

Study Completion

December 24, 2025

Last Updated

May 6, 2026

Record last verified: 2026-04

Data Sharing

IPD Sharing
Will not share

Locations