Effect of Masticatory Electrical Stimulation on Dysphagia in Spastic Cerebral Palsy
Effect of Masticatory Electrical Stimulation on Dysphagia in Spastic Cerebral Palsy
Sponsors
Source
Cairo University
Oversight Info
Has Dmc
Yes
Is Fda Regulated Drug
No
Is Fda Regulated Device
No
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.
Detailed Description
Study design:
A randomized controlled clinical trial was conducted after interviews were done with the
parents or care givers of all children, before starting the study to demonstrate the aim,
procedures and potential benefits of the study. Children' parents provided written informed
consent before the study was conducted.
Participants:
Forty spastic CP children (26 girls and 14 boys), age ranging from 2 to 5 years, participated
in this study. They were selected based on the following criteria; having at least score
(level 4) according to functional oral intake scale (FOIS), and they had good head control.
Children were excluded if they had; oral hypersensitivity, acute or chronic dental problems,
released primitive reflexes as asymmetrical tonic neck reflex or Seizures.
Participants who met the eligible criteria were assigned randomly to either study or control
group of equal numbers. Each child in both groups received an oro-motor exercises program as
home routine 3 times daily before each meal. Children in the study group received 20-minutes
of neuromuscular electrical stimulation (NMES) (multi current SND 64227) which consisted of
two-channels electrotherapy system designed for neuromuscular rehabilitation. The NMES was
applied with 60 Hz of 230 milliseconds twice weekly for 8 weeks. While participants in the
control group received placebo NMES.
Procedures:
Assessment:
1. weight and height Weight and height of each child were measured pre and post treatment
by using weight and height measuring scale.
2. Feeding level Dysphagia feeding level was assessed by using functional oral intake scale
(FOIS) , taking into consideration that tube dependent children at levels from 1-3 were
excluded from the study).
3. Assessment of oromotor skills by oromotor assessment scale (OMAS).
Treatment:
Home routine exercises The exercises were demonstrated to the parents to warrant the
uniformity of the training program. They were instructed to conduct the exercises three times
daily before each meal. This home routine included passive movement, active movement and
sensory stimulation.
1. Passive movement exercises:
Passive movement included massage and passive range of motion (ROM) exercises.
A-Massage: for gums, cheeks, lips and tongue for ten repetitions.
- Gum massage: upper and lower gum massage started from middle of the gum to the end
in the right and left side using regular brush.
- Lip massage: started from side to side, it was applied for the upper then the lower
lips.
- Cheek massage: Applied intra oral in a circular way.
- Tongue massage: Applied in the lateral side of the tongue from backward to forward
direction in the right and left side using regular tooth brush.
B-Passive range of motion was done for jaw, tongue and lips for ten repetitions.
- Jaw movement: cupping lower jaw and move it up and down.
- Tongue movement: Moving tongue laterally (right and left) and upward directions
were done by tongue depressor and fingers.
- Movement for lip closure: pushing the lips passively against each other like a
kissing position.
2. Active movements:
Active movement included active ROM for jaw, cheeks and lips and stretching for lips.
A-Active ROM
- Active jaw ROM: Jaw closure against resistance through biting on tongue depressor
and holding for 6 seconds with ten times repetition.
- Active cheek ROM: Cheek compress by drinking from straws with different diameters.
B- lip stretching; Stretching upper and lower lips sustain twenty seconds for three
sets.
3. Sensory stimulation; Sensory stimulation was done through Lollipop exercise by
stimulation of lip closure, cheek and tongue movement through moving the lollipop in
different directions.
Neuromuscular electrical stimulation The NMES was applied by the neo-faradic stimulation (Two
channels system. The electrodes were applied bilaterally. The first channel was applied over
the neck between the hyoid and jaw, (approximately on the belly of the digastric muscle). The
second channel was applied on the side of the face, (approximately on the masseter muscle).
The intensity level was determined by visible muscle contractions without pain sensation. For
children in the study group, the intensity level was from 7 mA to 15 mA, the time of rise and
fall was equal (50% raise and 50% fall) and the time on and off was fixed as; 3,1s:3,1s.
While those in the control group received placebo NMES without any signals reached to the
muscles.
All children received the treatment sessions 20 minutes, twice/weekly for 2 months in
addition to home routine exercises.
Statistics:
Paired and unpaired t-test were conducted for comparison of the mean and slandered deviation
for the demographic characteristics, weight gain and height variables. Mann-Whitney U test
was conducted for comparison of median values of FOIS between both groups. Wilcoxon Signed
Ranks Test was conducted for comparison between pre and post treatment median values of FOIS
in each group.
The level of significance for all statistical tests was set at p < 0.05. All statistical
measures were performed through the statistical package for social studies (SPSS) version 22
for windows.
Results:
General characteristics of participants:
The pretreatment comparison between both groups showed insignificant difference regarding the
mean values of age, weight and height (p<0.05).
Regarding weight gain and height there was insignificant difference between both groups
before and after treatment (p>0.05). While pre and post treatment within group comparison
revealed significant difference in both groups (p<0.05).
Regarding the feeding level (FOIS) comparison of values between both groups considering the
feeding level showed a statistically significant difference in each group after treatment.
While between both groups, there was insignificant difference before treatment (p>0.05).
After treatment, there was significant difference between the study and the control groups in
FOIS (p<0.05).
Regarding to oromotor skills There was insignificant difference between both groups before
and after treatment (p>0.05), While a significant different was in each group after treatment
when comparing it with its pretreatment value was recorded (p<0.05)
Overall Status
Completed
Start Date
2017-08-01
Completion Date
2019-02-11
Primary Completion Date
2017-10-01
Phase
N/A
Study Type
Interventional
Primary Outcome
Measure |
Time Frame |
|
feeding level progress |
time of treatment was two months |
|
oromotor skills |
period of treatment was two months |
|
weight gain |
period of treatment was two months |
|
height |
period of treatment was two months |
Enrollment
40
Condition
Intervention
Intervention Type
Other
Intervention Name
Description
treatment study group with occupational exercises and electrical stimulation
Arm Group Label
Effect of electrical stimulation on dysphagia in cp
effect of oromotor exercise on dysphagia in cp
Other Name
occupational therapy and physical agents
Eligibility
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
Gender
All
Minimum Age
2 Years
Maximum Age
5 Years
Healthy Volunteers
No
Location
Facility |
|
Out Patient Clinic Faculty of Physical Therapy Cairo University Dokki El-Giza 12612 Egypt |
Location Countries
Country
Egypt
Verification Date
2019-09-01
Lastchanged Date
N/A
Firstreceived Date
N/A
Responsible Party
Responsible Party Type
Principal Investigator
Investigator Affiliation
Cairo University
Investigator Full Name
amira farag
Investigator Title
Principal Investigator
Keyword
Has Expanded Access
No
Condition Browse
Secondary Id
P.T.REC/012/001630
Number Of Arms
2
Arm Group
Arm Group Label
Effect of electrical stimulation on dysphagia in cp
Arm Group Type
Experimental
Description
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.
Arm Group Label
effect of oromotor exercise on dysphagia in cp
Arm Group Type
Experimental
Description
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.
Firstreceived Results Date
N/A
Acronym
CP
Patient Data
Sharing Ipd
No
Ipd Description
It is not yet known if there will be a plan to make IPD available.
Firstreceived Results Disposition Date
N/A
Study Design Info
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.
Primary Purpose
Treatment
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.
Study First Submitted
August 28, 2019
Study First Submitted Qc
September 9, 2019
Study First Posted
September 11, 2019
Last Update Submitted
September 12, 2019
Last Update Submitted Qc
September 12, 2019
Last Update Posted
September 16, 2019
ClinicalTrials.gov processed this data on January 23, 2020
Conditions
Conditions usually refer to a disease, disorder, syndrome, illness, or injury. In ClinicalTrials.gov,
conditions include any health issue worth studying, such as lifespan, quality of life, health risks, etc.
Interventions
Interventions refer to the drug, vaccine, procedure, device, or other potential treatment being studied.
Interventions can also include less intrusive possibilities such as surveys, education, and interviews.
Study Phase
Most clinical trials are designated as phase 1, 2, 3, or 4, based on the type of questions
that study is seeking to answer:
In Phase 1 (Phase I) clinical trials, researchers test a new drug or treatment in a small group of people (20-80) for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
In Phase 2 (Phase II) clinical trials, the study drug or treatment is given to a larger group of people (100-300) to see if it is effective and to further evaluate its safety.
In Phase 3 (Phase III) clinical trials, the study drug or treatment is given to large groups of people (1,000-3,000) to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
In Phase 4 (Phase IV) clinical trials, post marketing studies delineate additional information including the drug's risks, benefits, and optimal use.
These phases are defined by the Food and Drug Administration in the Code of Federal Regulations.
In Phase 1 (Phase I) clinical trials, researchers test a new drug or treatment in a small group of people (20-80) for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
In Phase 2 (Phase II) clinical trials, the study drug or treatment is given to a larger group of people (100-300) to see if it is effective and to further evaluate its safety.
In Phase 3 (Phase III) clinical trials, the study drug or treatment is given to large groups of people (1,000-3,000) to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
In Phase 4 (Phase IV) clinical trials, post marketing studies delineate additional information including the drug's risks, benefits, and optimal use.
These phases are defined by the Food and Drug Administration in the Code of Federal Regulations.