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Completed

NCT Number: NCT04894513

Electro Physiological Responses to Kabat Motor Control Re-education on Bell's Palsy: A Randomized Controlled Study

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.

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Key information

Age range

12 year–16 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Lama S Mahmoud

Al Jīzah, Select State, Egypt

About this study

Thirty children with bell's palsy will participate in this study. The patients will randomly be divided into two equal groups; the control group received the conventional selected program, and the study group received the same exercise training program in addition to Kabat motor control re-education therapy. The program of treatment will be three times per week for six weeks.

The evaluation methods: Facial nerve distal latency, amplitude, and percentage of degenerations via the Neuropack S1 MEB9004 EMG device, the Facial Disability Index, and Sunnybrook facial grading system (SBFGS) all the assessment methods before the program and after finishing the program

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • 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

Treatment and study plan

Kabat motor control re-education therapy

Other

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.

conventional selected program

Other

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.

Primary outcomes

  1. Electroneurography

    Time frame: 6 weeks

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

  2. Electroneurography

    Time frame: 6 weeks

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

  3. Electroneurography

    Time frame: 6 weeks

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

Secondary outcomes

  1. Sunnybrook facial grading system (SBFGS)

    Time frame: 6 weeks

    it is a clinical grading system of facial function in facial palsy. It consists of 13 items-3 resting, 5 voluntary movement and 5 synkinesis items-answered on categorical answering scales. A SB composite score (range 0-100) and resting symmetry (range 0-20), voluntary movement (range 20-100) and synkinesis subscores (0-15) can be calculated.

Sponsors and collaborators

Lead sponsor

Lama Saad El-Din Mahmoud

Other

Registry information

Important dates

Study start
2021
Primary completion
2021
Study completion
2021
First posted
May 20, 2021
Registry last updated
Aug 9, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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