NCT04894513

Brief Summary

To investigate the Effect of Kabat motor control re-education therapy on facial nerve Electro physiological responses and facial muscles function in bell's palsy. BACKGROUND: facial nerve recovery in children could be improved through facilitation of nerve regeneration which can be enhanced through Kabat motor control re-education therapy.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Feb 2021

Shorter than P25 for not_applicable

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 15, 2021

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

April 13, 2021

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 15, 2021

Completed
5 days until next milestone

First Posted

Study publicly available on registry

May 20, 2021

Completed
10 days until next milestone

Study Completion

Last participant's last visit for all outcomes

May 30, 2021

Completed
Last Updated

August 9, 2021

Status Verified

August 1, 2021

Enrollment Period

3 months

First QC Date

April 13, 2021

Last Update Submit

August 2, 2021

Conditions

Outcome Measures

Primary Outcomes (3)

  • Electroneurography

    Measuringthe Facial nerve distal latency measured in millisecond (ms).via the Neuropack S1 MEB9004 EMG device

    6 weeks

  • Electroneurography

    Measuring the Facial nerve amplitude measured in (mv).via the Neuropack S1 MEB9004 EMG device

    6 weeks

  • Electroneurography

    Measuring the Facial nerve percentage of degenerations measured in(%).via the Neuropack S1 MEB9004 EMG device

    6 weeks

Secondary Outcomes (1)

  • Sunnybrook facial grading system (SBFGS)

    6 weeks

Study Arms (2)

study group

EXPERIMENTAL

the study group received the conventional selected program in addition to Kabat motor control re-education

Other: Kabat motor control re-education therapyOther: conventional selected program

control group

EXPERIMENTAL

the control group received the conventional selected program

Other: conventional selected program

Interventions

Kabat motor control re-education therapy that includes specific movements with predefined patterns of facial muscles exercises, which is spiral and diagonal movements involve the facial muscles, which are brought to train in global patterns. The program of treatment for three times per week for six weeks.

study group

the conventional selected program in the form of electrical stimulation (Faradic current) of affected muscles, facial muscle exercise program in front of the mirror, and home advices.

control groupstudy group

Eligibility Criteria

Age12 Years - 16 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Thirty child diagnosed as acquired bell's palsy with unilateral peripheral facial paralysis
  • Both gender
  • Their age ranged from 12:16 years old.

You may not qualify if:

  • difficulty to communicate or to understand program instructions
  • Oral dentures, Skin infection and metal implants on face
  • Sensory loss over the face, Recurrent facial paralysis
  • any other disorders or neurological deficits,
  • a history of surgical intervention for the ear and facial nerve palsy
  • pain of any other origin
  • non co-operative patients

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Lama S Mahmoud

Al Jīzah, Select State, Egypt

Location

Related Publications (1)

  • Hamed SA, Saad El-Din Mahmoud L, Magdy ElMeligie M, Zoheiry IM. Electrophysiological responses to Kabat motor control re-education on Bell's Palsy: A randomized controlled study. J Musculoskelet Neuronal Interact. 2023 Mar 1;23(1):90-97.

MeSH Terms

Conditions

Bell Palsy

Condition Hierarchy (Ancestors)

Herpesviridae InfectionsDNA Virus InfectionsVirus DiseasesInfectionsMouth DiseasesStomatognathic DiseasesFacial Nerve DiseasesCranial Nerve DiseasesNervous System Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: control group which received conventional selected program, and study group received the same exercise training program in addition to Kabat motor control re-education therapy
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Lecturer of physical therapy, Department of Neuromuscular disorders and its surgery, faculty of physical therapy, october 6 univerisity

Study Record Dates

First Submitted

April 13, 2021

First Posted

May 20, 2021

Study Start

February 15, 2021

Primary Completion

May 15, 2021

Study Completion

May 30, 2021

Last Updated

August 9, 2021

Record last verified: 2021-08

Data Sharing

IPD Sharing
Will not share

Locations