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Effect of Masticatory Electrical Stimulation on Dysphagia in Spastic Cerebral Palsy (CP)

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ClinicalTrials.gov Identifier: NCT04086355
Recruitment Status : Completed
First Posted : September 11, 2019
Last Update Posted : September 16, 2019
Sponsor:
Information provided by (Responsible Party):
amira farag, Cairo University

Brief Summary:
This study was conducted to evaluate the effectiveness of masticatory muscles electrical stimulation on oromotor skills, feeding level progress and child growth in children with dyaphagia. Forty children diagnosed as spastic cerebral palsy, from both genders, age ranging from 2 to 5 years were enrolled in the current study. They were randomly allocated in to study group (A) received oromotor exercises and neuromuscular electrical stimulation on masseter and digastric muscles and control group (B) received same exercises but placebo electrical stimulation. The result showed significant improvement in all variables in both groups. However, the study group showed significant different in feeding level in compare with control group.

Condition or disease Intervention/treatment Phase
Dysphagia Other: oromotor exercises and neuromuscular electrical stimulations Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: two parallel groups ,study group received oro motor exercise and neuromuscular electrical stimulation on masseter and digastric muscles.control group received the same but placebo electrical stimulation.
Masking: Single (Participant)
Masking Description: participants did not have knowldge if they in study or in control group ,as the exercises applied the same in both group and electrical stimulation the same ,the device turn on in both groups but their is no real signals reached to control group.
Primary Purpose: Treatment
Official Title: Effect of Masticatory Electrical Stimulation on Dysphagia in Spastic Cerebral Palsy
Actual Study Start Date : August 1, 2017
Actual Primary Completion Date : October 1, 2017
Actual Study Completion Date : February 11, 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Effect of electrical stimulation on dysphagia in cp
the study group that was treated by selected oromotor exercise program in addition to neuromuscular electrical stimulation, Feeding level progress was evaluated by functional oral intake scale,oro motor skills were evaluate by oromotor assessment scale, weight gain and height were measured pre and post 2 months of the treatment.
Other: oromotor exercises and neuromuscular electrical stimulations
treatment study group with occupational exercises and electrical stimulation
Other Name: occupational therapy and physical agents

Experimental: effect of oromotor exercise on dysphagia in cp
the control group was treated by the same oromotor exercise program in addition to placebo effect of neuromuscular electrical stimulation. Feeding level progress was evaluated by functional oral intake scale,oro motor skills were evaluate by oromotor assessment scale, weight gain and height were measured pre and post 2 months of the treatment.
Other: oromotor exercises and neuromuscular electrical stimulations
treatment study group with occupational exercises and electrical stimulation
Other Name: occupational therapy and physical agents




Primary Outcome Measures :
  1. feeding level progress [ Time Frame: time of treatment was two months ]
    functional feeding level evaluated with functional oral intake scale .this scale contain one item (feeding level) .the score ranging from level one to level seven seven levels ,the best level is level seven ( total oral intake without restrictions) the worth level is level one 9tube dependent .the final score is the number of level .assessed pre and post treatment

  2. oromotor skills [ Time Frame: period of treatment was two months ]
    oro motor assessment scale assess oromotor skills , it has seven items each item has four scores from zero to three, zero the worth and three the best. Each item was assessed 30 s. Their was no interfering with the way the caregiver or the child ingested the food, When the child presented more than one type of oral motor skill for the same item, the most frequently used skill was considered during the assessment. The final classification score of oral motor skill was attributed based on the most frequent score and if there was a tie between two scores, the highest score determined the diagnosis of the predominant type oro motor skills assessed pre and post ttt

  3. weight gain [ Time Frame: period of treatment was two months ]
    assess weight pre and post ttt by weight measuring scale.Child who able to stand was asked to stand on the weight measuring scale and record the weight of the child as show in The child who unable to stand assess weight of mother while carrying the child and record the weight then assess weight of mother alone and record her weight also ,then substract to find the weight of child in kg

  4. height [ Time Frame: period of treatment was two months ]
    assess height pre and post ttt by height measuring scale.Child who able to stand was asked to stand on the height measuring scale and elevate the arm of the height measuring scale till the vertex of the child then the height was recorded. child who unable to stand ask mother to lie the child supine line position then take land mark from the far point of the head , then take also land mark from the most far point from the heel and keep knee extended, after that measure the distance between two land mark and record the height in cm .



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Ages Eligible for Study:   2 Years to 5 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Diagnosis of spastic cerebral palsy.
  • age ranged from 2 to 5 years.
  • They had score level 4 or more according to functional oral intake scale (FOIS)
  • They had head control

Exclusion Criteria:

  • oral hypersensitivity.
  • any acute or chronic dental problems
  • released primitive reflexes as asymmetrical tonic neck reflex.
  • seizures
  • genetic syndrome

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04086355


Locations
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Egypt
Out Patient Clinic Faculty of Physical Therapy Cairo University
Dokki, El-Giza, Egypt, 12612
Sponsors and Collaborators
Cairo University
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Responsible Party: amira farag, Principal Investigator, Cairo University
ClinicalTrials.gov Identifier: NCT04086355    
Other Study ID Numbers: P.T.REC/012/001630
P.T.REC/012/001630 ( Registry Identifier: Research Ehical committee of faculty of pysical therapy )
First Posted: September 11, 2019    Key Record Dates
Last Update Posted: September 16, 2019
Last Verified: September 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: It is not yet known if there will be a plan to make IPD available.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by amira farag, Cairo University:
Dysphagia; electrical stimulation; cerebral palsy
Additional relevant MeSH terms:
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Deglutition Disorders
Cerebral Palsy
Brain Damage, Chronic
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Esophageal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Pharyngeal Diseases
Otorhinolaryngologic Diseases