Donna L. Bourdon
Administrator/CEO
FDA determination was decisive - Our observations are empirical and certainly more studies need to be done, but it is my opinion that without VitalStim® Therapy treatment we would not have seen the dramatic improvements - particularly in the patients who were receiving tube feedings.
In August 2003 three of our therapists attended the three-day VitalStim Therapy training.
We were so impressed with the treatment modality that we bought our first unit on the Monday following training and started treating patients on Tuesday. We observed such phenomenal results that we bought a second unit within a month. We did not want to be forced to treat one patient with state-of-the-art therapy while relegating another patient to more archaic methods for lack of equipment.
As CEO of a rehabilitation hospital, and a Speech Pathologist by training, I understood the clinical advantages VitalStim Therapy offered. The FDA's determination that the therapy is safe and effective satisfied the risk management concerns. This was an important determinant in implementing the program.
Later, when we looked at the first 13 patients we treated between August and December of 2003, the results showed that we had made the right decision.
Data on the effectiveness of traditional methods show that only about 2% of patients with neurological disorders and on PEG feedings return to full oral eating within one year. Five of the 13 patients we treated in 2003 were on PEG tube feeding. We were able to return all to oral feeding within 30 days and remove the PEG tubes. Three returned to regular diets, one to a mechanical soft diet and one was able to tolerate a puree diet.
The remaining eight also made impressive progress in their ability to return to an oral diet, some to mechanical soft food and others to a regular diet.
Would some of these patients have spontaneously recovered their ability to eat anyway?
Admittedly, our observations are empirical and certainly more studies need to be done, but it is my opinion that without VitalStim Therapy treatment we would not have seen the dramatic improvements - particularly in the patients who were receiving tube feedings.
Treating these patients with conventional therapies, such as thermal stimulation, would have resulted in longer duration of treatment with less desirable results regarding the consistency of the foods tolerated.
Our results were achieved with an average of 22 VitalStim Therapy sessions per patient. Of the tube-fed patients, 100% advanced to a diet. And 93% advanced to either a mechanical soft diet or a regular diet.
With VitalStim Therapy, we saw wonderful quality of life outcomes that would not have been possible otherwise.