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Using Facial-Flex® to Assist Treatment of Articulation Disorders
Supervised by: Judith Creed, M.A., SLP-CCC, Joseph R. Spiegel, M.D., FACS

ABSTRACT
Facial-Flex was used as an adjunct to traditional speech therapy in a population of school-age children being treated for articulation disorders. 133 children were chosen from a group of 1,200. Children 10 years and under used the pediatric model and children 11 years and older used the adult model. All subjects were compared to an age-matched control group.

47 children were totally compliant and available for evaluation. All children demonstrated improvement of oral motor strength, with an average improvement of 467% in repetition index and 224% in closure time index. Eight children had a significant improvement in articulation attributable to Facial-Flex use after the 8-week study protocol.

INTRODUCTION
A study was designed to evaluate the safety and efficacy of Facial-Flex in children, to evaluate the usefulness of Facial-Flex as an adjunct to traditional speech therapy and to compare the adult and pediatric Facial-Flex appliances. Prior to this study the Facial-Flex appliance had not been tested for clinical effectiveness in children. The pediatric and adult models of Facial-Flex were provided to 133 children receiving speech therapy in their school secondary to diagnosed articulation disorders. Each child was monitored by a certified speech-language pathologist and received traditional speech therapy for their disorders. An age-matched control group was constructed for comparison. The study was designed to evaluate the use of both models in children, evaluate the efficacy of building facial muscle strength in children using the device and evaluate the result of a short course of Facial-Flex use on traditional speech therapy for many different articulation disorders.

BACKGROUND
The Facial-Flex appliance is utilized for mechanical assistance in a program of facial exercise. It provides dynamic resistance to the circumoral muscles and has been shown to strengthen these muscles when used in a program to maintain constant resistance with daily use. Facial-Flex is currently registered as an FDA Class I Medical Device. It can be sold and used as an exercise device without prescription. The device consists of 2 plastic-tipped stainless steel rods which slide across one another. The geometry is such that constant external resistance can be provided throughout the dynamic range by replaceable elastic bands of known resistance. The device is placed horizontally between the upper and lower lips and seated at the corner of the mouth. The user then presses the corners of the lips against the resistance of the device to make a small oval. This position is held for just a second or two, then gently released. After the device has forced the corners of the lips as far apart as possible, the user repeats the compression step. This sequence is repeated for 2 minutes or terminated at muscle fatigue, whichever comes first. After 2 minutes of rest, the entire sequence is repeated for 2 minutes or until muscle fatigue. The Pediatric Facial-Flex has been developed for smaller mouths and provides a program of progressive dynamic resistance with a series of color-coded devices.

Facial-Flex provides assistance in a type of facial exercise that is commonly a component of speech therapy for many different articulation disorders. Facial-Flex was introduced to speech therapists about 1 year ago and there was immediate interest in the use of the device in children who require speech therapy for articulation disorders during primary school years. Some children have documented weakness of the circumoral and other facial muscles, and it is hypothesized that those children may show an improved response to traditional speech therapy when an adjunctive exercise is added. Additionally, children with demonstrated coordination problems of these muscle groups may show improved response to speech therapy if a successful program of muscle strengthening is accomplished.

MATERIALS AND METHODS
Subjects were students in Philadelphia non-public schools with speech services provided by CORA Services, Inc. From a total population of 1,200 children, 201 were selected as potential candidates for study based on the presence of one or more of the following criteria:

  • Apraxia
  • Suspected weakness and incoordination of oral-motor function
  • Poor stimulability for production of early developing phonemes: /p,b,f,v,w,wh,l/
  • Poor stimulability for production of 2 or more targeted phonemes.
  • Poor stimulability for production of /r/.

133 of the 201 children were able to obtain parental consent. A control group of 133 children matched for age and articulation errors was created and monitored throughout the course of the study. Twelve certified speech-language pathologists participated in the study.

The treatment course lasted 8 weeks. All of the children completed articulation evaluation before and after the course of treatment. In the treatment group, children 10 years and under were given the pediatric device and children 11 years and older were given the adult version. An attempt was made to involve the parents in the initial training. The children were asked to keep daily logs of Facial-Flex use and these were monitored by the speech pathologists.

Each child was asked to use the Facial-Flex device for two 4-minute sessions each day. The most suitable strength of the device for each child was determined by their ability to perform 2 minutes of exercise. A strength that allowed the easy performance of 2 minutes of constant exercise was chosen. After 4 weeks of tolerated use, each child was moved to the next higher strength if it was tolerated. The daily logs required a recording of the strength of the device or weight of the elastic bands used and the number of repetitions performed in each 2-minute session.

Results were assessed by multiple methods. All of the subjects underwent articulation testing at the start and the end of the protocol period. Response to treatment was based on the subjective judgment of the treating therapist. In addition to the completed logs, each subject had their Facial-Flex use measured at the beginning, at the halfway point (4 weeks) and at the end of the protocol. Two tests were utilized: maximal repetitions in 2 minutes and maximum amount of time in closed position.

RESULTS
Of the 133 children in the treatment group, 21 were excused from the study because of non-compliance. 65 children were found to be partially compliant based on inconsistent performance of the protocol, inconsistent record-keeping with the daily log, less than 90% attendance or questioned validity of records. 47 were found to be totally compliant. Twenty-seven children (57%) completed the study with the adult device and twenty (43%) used the pediatric device. The age range of the pediatric group was 5 through 9 and the adult group was 8 through 16.

These 47 children were evaluated for response to Facial-Flex use by examining the maximal repetition and maximal closed time tests. Each value was multiplied by the strength of resistance used in the test for an index score (repetition index (Rl)) and closed time index (CTI), and the indexes were compared from the beginning and end of the protocol to determine improvement in function of the muscles undergoing repeated exercise. All of the children showed improvement in both measures. The total group showed an average of 467% improvement in Rl and 224% in CTI. In the pediatric group, the smallest average improvement was 66% and the greatest was 2838%. In the adult group, the smallest average improvement was 42% and the greatest was 2100%.

Based on the results, 5 groups of disorders were determined: /r/ (46%), /r/ and /l/ (6%), lateral (3%), fricatives (11%) and multiple articulation deficits (34%). 44 of 45 (98%) of children with multiple articulation deficits had errors that included the /r/ phoneme.

There was no difference in results of the articulation tests between the study group and the control group. However, the treating speech pathologists identified 8 children who demonstrated improvement in oral facial strength as measured by both the Rl and CTI. These same children also were noted to have improvement in articulation that could not be attributed to the traditional speech therapy. This group included one 7-year-old, two 8-year-olds, two 9-year-olds, a 10-year-old, an 11-year-old and a 14-year-old. The 5 older children used an adult model and the 3 younger children used the pediatric model. Seven of the children had difficulty with the /r/ phoneme as their primary articulation disorder and 1 child had primary difficulty with lateral emission on /sh/ and /ch/.

The therapists involved in the study were asked to comment on ease of use of the Facial-Flex devices in different age groups. All the therapists reported that the pediatric device was not as effective in children 8 years old and older because it was too small. The adult device was successfully applied in many children 8 to 10 years old who had a poor fit with the pediatric model. The therapists also noted that compliance was directly related to parental involvement in both the initiation and ongoing reporting of the study.

DISCUSSION
This study demonstrates safe and efficacious use of Facial-Flex in the pediatric population. The pediatric device was easily fit in children between the ages of 5 and 8. It was presumed at the outset of the study that all children 10 years old and under would use the pediatric model, but during the study it became apparent that most children over 8 years old are better fit with the adult model. The use of both models was easily taught during a single session with the speech therapist assisted by an instructional videotape. Forty-seven subjects (35%) were totally compliant for both usage and reporting requirements of the protocol. 112 subjects (84%) were either totally or partially compliant. Only 2 subjects stopped use because of discomfort and neither had any further complaints after the use was discontinued.

Improvement in facial strength was consistent and measurable in children using both the pediatric and adult models. The parameters utilized to measure improved muscle strength, Rl and CTI, more than doubled. All the subjects demonstrated improvement.

A specific benefit in treatment of articulation disorders was noted in children with /r/ phoneme difficulties. This represented the largest group in the study, and 7 children (12%) were found to improve so dramatically during the 8-week period that their therapists attributed the response to Facial-Flex use. Another child with /sh /and /ch/ difficulties also made remarkable progress. This articulation disorder is similar to the /r/ phoneme complaint because correction requires alteration of unobservable tongue position. These findings raise the possibility that use of the Facial-Flex will assist in teaching mid-tongue position for specific articulation problems. The presumed mechanism of this correction would involve improved oral closure and improved lip and tongue coordination as a result of improved facial muscle strength.

Future studies of Facial-Flex will be designed to target pediatric populations with /r/ phoneme disorders and those with articulation deficits secondary to documented oral motor weakness. Additionally, with more time set aside for parent education and contact, improved compliance can be expected.

CONCLUSIONS
  • Facial-Flex pediatric and adult models can be safely and effectively used in the pediatric population
    as young as age 5.
  • Improvement of circumoral muscle strength was demonstrated after an 8-week exercise program with both the pediatric and adult models.
  • Most children 8 or older will be best fit with the adult model.
  • Use of Facial-Flex may provide a significant benefit in the treatment of disorders of r/phoneme articulation and other problems associated with unobservable tongue position.
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