Effect of Masticatory Electrical Stimulation on Dysphagia in Spastic Cerebral Palsy

NCT04086355 | Completed DMC

• 2 other identifiers: P.T.REC/012/001630NCT04086355
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Dysphagia

Keywords

Dysphagia; electrical stimulation; cerebral palsy

Outcome Measures

Primary Outcomes (4)

• feeding level progress

  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

  time of treatment was two months

• oromotor skills

  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

  period of treatment was two months

• weight gain

  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

  period of treatment was two months

• height

  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 .

  period of treatment was two months

Study Arms (2)

Effect of electrical stimulation on dysphagia in cp

EXPERIMENTAL

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

effect of oromotor exercise on dysphagia in cp

EXPERIMENTAL

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

Interventions

oromotor exercises and neuromuscular electrical stimulations OTHER

treatment study group with occupational exercises and electrical stimulation

Also known as: occupational therapy and physical agents

Effect of electrical stimulation on dysphagia in cp; effect of oromotor exercise on dysphagia in cp

Eligibility Criteria

• Age: 2 Years - 5 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

Out Patient Clinic Faculty of Physical Therapy Cairo University

Dokki, Giza Governorate, 12612, Egypt

Location

MeSH Terms

Conditions

Deglutition Disorders; Cerebral Palsy

Interventions

Occupational Therapy

Condition Hierarchy (Ancestors)

Esophageal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Pharyngeal Diseases; Otorhinolaryngologic Diseases; Brain Damage, Chronic; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Therapeutics

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: 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.

Study Record Dates

• First Submitted: August 28, 2019
• First Posted: September 11, 2019
• Study Start: August 1, 2017
• Primary Completion: October 1, 2017
• Study Completion: February 11, 2019
• Last Updated: September 16, 2019

Record last verified: 2019-09

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)