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Effects of Massage Therapy and Facial PNF in Early Bell's Palsy

Primary Purpose

Bell Palsy

Status
Completed
Phase
Not Applicable
Locations
Pakistan
Study Type
Interventional
Intervention
Facial PNF technique
Massage therapy
Sponsored by
Neuro Counsel Hospital, Pakistan
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Bell Palsy

Eligibility Criteria

20 Years - 50 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria: Both males and females with age between 20 to 50 years All patients diagnosed with Bell's palsy Non traumatic onset Acute onset 1 to 3 weeks Either right or left side Exclusion Criteria: Subject who have other Neurological disorder Subjects who have impaired cognition Complete paralysis of face Open wound on face

Sites / Locations

  • Al Nafees Medical Hospital, Islamabd

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

control group

experimental group

Arm Description

massage therapy will be given to this group of participants

Facial PNFtechnique will be given to this group of participants

Outcomes

Primary Outcome Measures

Sunnybrook facial grading scale
complete tool for assessing facial movement outcomes. Lower score (Zero) means complete paralysis and higher (100) means normal
Facial Clinimetric Evaluation Scale
to evaluate the impairment and disability associated with facial weakness. It is calculated ranging from 0 (worst) to 100 (best)

Secondary Outcome Measures

Full Information

First Posted
December 15, 2022
Last Updated
March 10, 2023
Sponsor
Neuro Counsel Hospital, Pakistan
Collaborators
Al Nafees Medical Hospital, Islamabad, Reliance Hospital Rawalpindi
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1. Study Identification

Unique Protocol Identification Number
NCT05679752
Brief Title
Effects of Massage Therapy and Facial PNF in Early Bell's Palsy
Official Title
Effects of Massage Therapy and Facial PNF in Early Bell's Palsy
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Completed
Study Start Date
September 21, 2022 (Actual)
Primary Completion Date
December 14, 2022 (Actual)
Study Completion Date
December 14, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Neuro Counsel Hospital, Pakistan
Collaborators
Al Nafees Medical Hospital, Islamabad, Reliance Hospital Rawalpindi

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
Effects of Massage therapy and Facial PNF in early Bell's palsy
Detailed Description
It is an interventional study in which investigator will give massage therapy to one group of patients and facial PNF techniques to other group to evaluate the efficacy of these intervention on bell's palsy pateints

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bell Palsy

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Randomized control trail
Masking
Participant
Masking Description
single blind RCT in which just participants do not know in which group they are being treated
Allocation
Randomized
Enrollment
30 (Actual)

8. Arms, Groups, and Interventions

Arm Title
control group
Arm Type
Active Comparator
Arm Description
massage therapy will be given to this group of participants
Arm Title
experimental group
Arm Type
Experimental
Arm Description
Facial PNFtechnique will be given to this group of participants
Intervention Type
Other
Intervention Name(s)
Facial PNF technique
Other Intervention Name(s)
Proprioceptive Neuromuscular Facilitation
Intervention Description
Stimulation techniques used to facilitate the weak muscle groups
Intervention Type
Other
Intervention Name(s)
Massage therapy
Other Intervention Name(s)
Passive massage
Intervention Description
frictional massage to stimulate the weak muscle groups
Primary Outcome Measure Information:
Title
Sunnybrook facial grading scale
Description
complete tool for assessing facial movement outcomes. Lower score (Zero) means complete paralysis and higher (100) means normal
Time Frame
assessment will be done after 6 weeks
Title
Facial Clinimetric Evaluation Scale
Description
to evaluate the impairment and disability associated with facial weakness. It is calculated ranging from 0 (worst) to 100 (best)
Time Frame
assessment will be done after 6 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Both males and females with age between 20 to 50 years All patients diagnosed with Bell's palsy Non traumatic onset Acute onset 1 to 3 weeks Either right or left side Exclusion Criteria: Subject who have other Neurological disorder Subjects who have impaired cognition Complete paralysis of face Open wound on face
Facility Information:
Facility Name
Al Nafees Medical Hospital, Islamabd
City
Islamabad
State/Province
Federally Administered Tribal...
ZIP/Postal Code
44010
Country
Pakistan

12. IPD Sharing Statement

Plan to Share IPD
Undecided
IPD Sharing Plan Description
Still not decided about this.

Learn more about this trial

Effects of Massage Therapy and Facial PNF in Early Bell's Palsy

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