PROGRAM DESCRIPTION
CP-300 is a computerized version of the Clinical
Perineometer™ (Model CP-100) which was designed by Dr. John
D. Perry and William Farrall, and is manufactured by Farrall Instruments,
Inc. It provides the same "flick", "hold"
and "endurance" tests, and provides a summary printout
of results. Like the Clinical Perineometer™, it conforms
to Dr. Perry's "Software Standards for the Electronic Perineometer
(1984)", the internationally recognized data collection and
reporting format for pelvic muscle work. In addition, the CP-300
program provides a unique biofeedback practice program, the "Kegel
Counter", which permits the therapist to define a "valid"
practice contraction for a particular patient; then the program
guides the patient through a pre-determined number of criterion-referenced
exercises. [Later versions of CP-300 may include a simulated "strip
chart" feature.]
We strongly recommend the concomitant purchase and
use of J&J's "V8" software program, which provides
many additional useful exercise programs and greatly enhances
therapeutic effectiveness. V8 is not, however, suitable for diagnostic
and evaluation purposes in pelvic muscle work.
HARDWARE REQUIREMENTS
CP-300 is designed to run on (1) a Commodore C-64
type Computer System (Including C-64, SX-64, C-64-C, or C-128)
with the following components: a C-64 CPU, one Disk Drive, one
(or more) Video Monitor(s), one Printer (optional but very desirable)
with (2) a J&J Model I-300 Computer interface containing at
least (3) one Model M-501 EMG preamplifier module. [Additional
EMG and other modules are useful when using the V8 program.]
As distributed, the program assumes that the EMG
module is connected to channel 6 (the standard assignment for
an I-300-M5xxx module as purchased from Biotechnologies, Inc.).
If your EMG is located elsewhere, see Note 1 for instructions
on making the change permanent. Note: to make only a temporary
change in assignment, you can type a new channel number (0 thru
9) instead when the Title Page says "Press ANY key to continue".
BOOTING THE PROGRAM
Type LOAD "*", 8 <Return> This causes the first part of the program to load. When the computer says "READY", type RUN <Return>, which causes several modules to be loaded in sequence. [The loading process is considerably faster if you install an FASTLOAD Cartridge, from Epyx, available for about $30 at most computer stores selling Commodore 64 products.] (On the SX-64 you need only type the special combination, Commodore+Run.)
TITLE PAGE
The Title Page identifies the Program, Author, and
the Licensed Owner. [The program is not "copy-protected",
but the licensed owner's name is embedded throughout the disk
to discourage theft. If you would like a copy with your own name
on it, please contact Biotechnologies, Inc. We'll be only too
happy to sell you one.] The boarder color now changes while waiting
to begin. Press any key to continue. If you wish to make a temporary
new assignment of EMG channel, press a numbered (0-9) key instead
of "any" key.
MENU PAGE
There are THREE basic options: Diagnostic Tests,
Practice Module, and Printer Initialization.
Initialization: In order to get a printout of results,
you must first "initialize" the printer. Selecting this
option by pressing "I" gives you a chance to type in
the Patient's Name <return>, the Date (only in the form
1/1/87<return> or any other form that does not include commas);
and up to one short line of "comments <return>".
We usually enter brief notes like "Fifth Visit - after 14
days practice".
You may omit the name, date, or comments lines, by
simply pressing <return> three times. Then you can fill
in the names in pen. In any case, the printer will print a header
which includes the name of the registered owner of the disk/program,
and the above information as soon as the third <return>
is entered.
There may be times when you don't want to print a "header". For example, if you had to STOP the program for some reason, and you already had a partially-completed report in the printer with a header already on it. If after STOP you elect to RUN again, you must again initialize the printer. You can initialize the printer (i.e., inform the computer that you wish test results to be printed on paper) without printing any header by entering "I<return>" at the Patient Name? request. Typing "I" for the patient name says "I only want to Initialize the Printer, not print anything yet." If you don't wish printed output, of course, simply DO NOT INITIALIZE the printer.
DIAGNOSTIC TESTING
The diagnostic tests have been enhanced to include Titles at the top of the screens so the sequence of events is clearer to you and the patient. Two additional enhancements apply to almost everything that follows:
(1) ReStart Option: Almost every activity can be "restarted" by pressing the letter "R". Usually this will cancel the current activity and take you back to its beginning. This is especially useful if, for example, the patient makes a gross postural adjustment in the middle of a test, thereby destroying the collected data's value and meaning.
(2) F7-Pause: Almost every activity can be "paused" by pressing the "F7" key, which causes the word "WAIT" to be printed in place of the current EMG level, and stops the timer, until any other key is pressed to resume the activity. This is useful if you wish to instruct the patient, for example, or comment on progress. Note that it would be misleading to interrupt any of the diagnostic tests for more than a few seconds, since six contractions done with a three minute rest in the middle doesn't mean the same as six contractions done one after another!
Due to the way the Commodore works, it sometimes "misses" the F7 key. If "WAIT" does not appear instantly, you'll have to press it again (and maybe again) until it does. The F7 key is checked each time the computer tries to take a sample from the sensor (i.e., while graphs are being drawn on the screen).
You may select the FLICK, HOLD, or ENDURANCE tests separately by pressing the F, H, or E keys. This will cause the selected test to run and then return you to the MENU page. To run all three tests in automatic sequence, simply press the SPACEBAR. If you start the automatic sequence, you must either finish it or "STOP/RESTORE" the whole program. (Then you would have to type "RUN<return>" to start over.) We consider that the "normal" way is to run the automatic sequence each time; that gives results which permit the most reliable inter-subject comparisons to be made.
FLICK TEST
The Flick Test measures the PEAK EMG level obtained in a pelvic muscle contraction. It is of dubious clinical merit, since it has not been shown to be a reliable predictor of anything. However, there is still good reason for obtaining this measure: if a person scores much higher on Flicks than Holds, you know that (1) they've been doing Kegel Exercises and (2) they've been badly instructed in the past, so that they have only practiced short contractions. Another reason for measuring it is that's what everyone used to measure using the Kegel Perineometer in the old days.
BASELINE SCREEN: The first step is to establish a "baseline measure" for the flick test, and to ensure that the patient is actually relaxed. The bottom of the screen shows the most recent sample on the left (Present EMG) and the accumulated mean or "baseline" (the number that will actually be used in the next step.) on the right If the mean is artificially high (due, for example, to a gross postural movement) you can restart the baseline section by pressing the letter R. When a reasonable baseline is established, press SPACEBAR to proceed.
A good baseline is under 1.0 microvolts. A reasonable baseline is under 2.0 microvolts. However, if the patient is especially apprehensive, or suffers from chronic pelvic tension, readings may be as high as 3 or even 5 microvolts. Under these conditions, it is best to focus on relaxation for a few moments -- or longer -- before proceeding with the evaluation.
High baseline levels could also result from mechanical or electrical problems. A reading of "155" or so is usually caused by a broken (open) EMG lead. Readings of 30 to 100 microvolts are virtually impossible, and should cause you to suspect that either the sensor is not fully inserted, or that the vagina or rectum is exceptionally dry (not making good contact) or exceptionally wet (due to either sexual arousal {vaginal} or use of excessive lubricant {rectal} when inserting the sensor.
If you obtain a "reasonable" baseline, it is probably safe to proceed with the testing. If the baseline is over 5 or 10 µvolts, however, you should test for electrode continuity the same as you would with surface EMG electrodes Ð with an ohmmeter connected across each possible pair of electrode leads (A-B, B-C, A-C). All lead combinations should show less than 20K Ohms for reliable results. Repositioning the sensor, reinserting it; substituting a light-weight "single-patient perineometer" sensor, or moving to a rectal placement are all possible alternatives. We have seen problems, for example, with patients wearing very tight bluejeans Ð which forced a sensor to "twist" slightly sideways in the vagina, enough to permit one silver pad to break contact with the skin and give false-high readings. When you have a good baseline, press SPACEBAR to proceed to:
FLICK TEST SCREEN: This screen includes a moving "fill graph" type display, with six red place-markers ready to receive six test values. The current PEAK contraction is shown, with the PRESENT EMG level below it. The baseline obtained in the previous step is displayed as a red line across the graph, and its value is printed in the lower right-hand corner.
The baseline is important in the algorithm used for "counting" a flick contraction. The "Present EMG" level must rise to at least 1 microvolt above the baseline and fall back below it again before contraction is "counted" as being complete. When that happens, each PEAK value is "grabbed" and placed over the red flick marker, in sequence 1 through 6 times. The therapist must verbally instruct the patient to Contract and Relax. If six flicks are not completed on one pass across the screen, it is redrawn and you can continue where you left off.
If the patient's muscle twitters around the baseline level, it can trigger a false "flick" recording. Prior to the completion of the sixth flick, the whole cycle can be restarted by typing R. Alternatively, one or two false readings can be overlooked. That is a matter for clinical judgement. Record such events in your notes; the inability to follow directions or to control the muscle is significant diagnostic information, in otherwise healthy alert patients.
PRINTOUT: When the sixth flick is recorded, the screen freezes and the results are sent to the printer, if one is connected. If not, you can copy down the numbers manually before pressing ANY KEY to continue.
PRINT BUFFER: We strongly recommend the use of our 64K Serial Printer Buffer for the Commodore/J&J system. It is almost essential with the V8 statistics program, absorbing a full screen printout in 21 seconds instead of a couple of minutes. This allows the therapist to proceed to set up the next printout at once, instead of waiting for the printer to finish. Non-stop printing is the result. At $99.95, it pays for itself in a month by saving precious office time.
If you pressed the "F" key to get here, you'll be returned to the menu page. Otherwise you next see:
HOLD TEST SCREEN
The program automatically administers six cycles of 10-second Rest and Hold Measurements. This is the single most important measurement, and the only one which significantly correlates with urinary control and sexual response in published research. If you only use one measure, it should be this one.
REST: The program begins with 10 seconds of rest, during which time the EMG level is accumulated. Note that the seconds 1-10 are ticking off in in yellow in the lower left-hand corner; the current cycle number is shown in blue just below the seconds, and the Present and Mean EMG levels are also displayed. The instruction "RELAX" appears in yellow below the left side of the graph area. A yellow "fill graph" is drawn, showing the present level. If a flick test has already been run, a red "relaxation" baseline is also displayed. Note whether the patient is able to maintain the same level of relaxation, or has trouble getting down below the threshold line.
HOLDS: After 10 seconds, the screen border turns RED, at which time the patient should be verbally instructed to "Contract and Hold it as strongly as you can while the red border is showing". The word "C O N T R A C T !!!" is printed in red below the graph. Verbal encouragement is helpful. A new MEAN EMG level is being accumulated (lower right). When the 10 seconds of "hold" have been accumulated, the word "RELAX" appears again; then the screen is redrawn, during which time the patient should be reminded to relax [i.e., they were only to contract when the red border was present, and now it is black again].
SUMMARY PAGE: At the conclusion of the test, a summary page is printed on the screen (and on the printer, if it was initialized). This shows the results for each trial, including resting level, contracting level, and the difference. At the bottom is shown the average resting level, the average contract level, and the average of the "difference" scores. The latter is the single most important score, but note that it is of course influenced by the average resting level; if the patient is tense, it is hard to interpret the difference score.
General Comments on the Hold Test: It is tempting to comment on the patient's progress, but restrain yourself while the hold test is going on. The patient must concentrate. Use your free time to observe whether the patient is using accessory muscles, holding the breath, etc. Make the testing situation as "standard" as possible. Patient education is most effective if offered during the practice modules.
If you pressed the "H" key to get to the Hold Test, you'll be returned directly to the Menu Page. If you pressed SPACEBAR, however, you'll go directly to:
ENDURANCE TEST
SAMPLE FLICK SCREEN: The module begins by asking the patient to "Make a strong contraction Now"; this should be a flick, and should be comparable to flicks produced on the FLICK TEST. If it is too high (unrepresentative of actual flicks) it will create an unrealistic (and therefore invalid) basis for the endurance test. In that case, press "R" to repeat the sampling procedure.
When the contraction rises above the relaxation level by at least one microvolt and then returns to baseline, the screen is frozen and the sample value is displayed. One-half of this value will be used in the next segment. Do not touch the keyboard until you are ready to have the patient continue! Take a moment to explain what follows next. When you press SPACEBAR, you will see:
ENDURANCE TEST: Verbally instruct the patient to "make a single strong contraction and hold it above the red line for as long as you can." The seconds will begin to be counted as soon as the contraction, which is also graphed, passes the red line. The timer will stop counting when it drops below the red line again.
Note: The program assumes that a contraction of 2 seconds or less was a false start, and continues graphing. If that happens, instruct the patient to try again, immediately. This screen does NOT repeat, since there is time for a full 30 seconds to be displayed. If an accurate standard has been established (in the preceding screen) then 30 seconds is enough to show good endurance. Usually patients who have only practiced flicks will drop out at 6 to 12 seconds.
BE SURE to prepare the patient for the endurance test BEFORE pressing the SPACEBAR to start it. If they don't start contracting within a few seconds there won't be enough time to complete the test.
RESULTS: At the completion, the screen displays the results (number of seconds the contraction was above 50% of "peak" strength), and the same is printed on the printer if one was connected and initialized.
Regardless of how you started, you will now be returned to the Menu Page.
At this point, you might discuss the obtained results with the patient. It is important to be positive in your presentation of the results, especially when the muscles are weak. One approach is to stress that the results are wonderful, because they are so terrible. That is, the muscles are definitely weak, and thus clearly account for the patient's problem. That's good news, because weak muscles can be readily trained with biofeedback, and that means the patient can get better, probably without surgery or drugs. The answer, of course, is biofeedback-assisted exercise, which by no coincidence happens to be the next option on the Menu Page.
PRACTICE MODULE
The most significant innovation in the Computerized Perineometer™ software program is the "Kegel Counter", or practice module. This program, which is not available in any other instrument, is designed to eliminate the most difficult problem in patient treatment -- self-deception -- and thus ensures compliance with therapeutic recommendations. The program accomplishes this objective by allowing the therapist to define what constitutes a "valid" exercise contraction, in terms of (1) strength of contraction and (2) required minimum relaxation levels between contractions. [Note: A future enhancement Ð "Structured Exercise" Ð will also allow the therapist to specify the (3) duration of each contraction required.] The result is that only valid contractions Ð those deemed by the therapist to be helpful Ð are counted by the program.
There are three choices for establishing the valid exercise parameters. First, you can "Press SPACEBAR to enter criterion levels directly, or you can "press any (other) key to begin taking samples" of resting and contracting levels.
NOTE: The "sampling" procedure was written when it was assumed that you might wish to evaluate progress before assigning exercise. It now seems easier to simply run the diagnostic portions of the program at the start of each training session. This sampling section may be eliminated in future revisions of the program; user feedback would be helpful here.
If you elect to take samples, you will be coached in taking a baseline and three sample contractions. You can read the screens to the patient as instructions, and then press SPACEBAR to precede. The graph on the baseline screen has a red line that represents the average of the last 10 samples (and thus changes rapidly). When you next press SPACEBAR, this average plus 20% will become the "resting baseline criterion" for the Kegel Counter. Press SPACEBAR again for instructions, which will quickly jump to three successive contraction trial screens. On each (one-third screen) the patient should make one good contraction. If a particular trial contraction seems to be unrepresentative (for example, if the patient actually made a postural adjustment during the trial) you can reject the trial by pressing "R" to repeat it. If the trial was OK, press SPACEBAR to accept it and move on to the next; the average is drawn on the (1/3) screen.
After the third trial is accepted, a summary page appears which explains the obtained results: the resting level plus 20% and the contraction average minus 20% will define a "valid" Kegel exercise. The screen explains that a contraction must go from below "x" to above "y" and back again to be counted. Press SPACEBAR to commence the exercise.
If, on the other hand, you elected direct entry rather than sampling, you are again given two choices. You can simply press the SPACEBAR again to accept "default" settings of 2.0 microvolts for relaxation criterion and 5.0 microvolts for contractions. [These settings will cover many patients, but by no means all of them.] Alternatively, you can then "Press any (other) key" to be offered an opportunity to type in your own numbers.
If you enter numbers manually from the keyboard, note that your keystrokes are not displayed until you press <Return> at the conclusions of each entry. For example, to set relaxation at 2.5 microvolts, press "2", ".", and "5", followed by the <Return> key. The "2.5" value will show after you press <Return>. Then do the same for the contraction criterion. Note that there must be more than 1.0 microvolts between the two figures, or the program will issue a complaint and force you to repeat the entry process.
PRACTICE:
The left side of the Kegel Counter screen shows (1) The number of "Kegels" actually complete (initially, zero); and (2) the number LEFT TO DO (initially 25). Below this is shown the instantaneous EMG LEVEL. In the lower left-hand corner you will see the number of seconds (two digits max.) in the current cycle counting off in the same color as the graph.
The Right side of the screen shows the accumulated statistics for this practice session, in four lines. The Top line (in red) shows the strength (in µV) and duration (in Secs.) of the most recently completed red (contract) cycle. The Second Line (also red) shows the Ave. strength (in µV) and duration (in Sec.) for all red (contract) cycles completed so far in this practice block. On the Third Line, in yellow, is shown the same data for the most recently completed yellow (rest) cycle, and finally, at the bottom, the same data for all yellow (rest) cycles in this practice block.
Note one programing bug: If the patient is not resting when the Kegel Counter starts, but begins the module on a "contract" cycle (red), the program will bomb with a divide by zero error as soon as the graph turns to yellow. To prevent this problem, never start while the patient is still moving around in the chair!
When starting, the fill graph is drawn in Yellow, and the object is to contract to reach the YELLOW (contraction) criterion line. When that happens, the fill graph changes to Pink, and after an appropriate time spent contracting, the object is to relax down to the PINK (relaxation) criterion line. This cycle constitutes one "valid" Kegel contraction, which is added on the incremental counter and deducted from the "LEFT TO DO" counter.
NOTE that a second contraction will NOT be countable until the graph changes back to yellow, at least momentarily. This is to ensure that the patient does not inadvertently learn simply to become tense, which is just as much a problem as muscle weakness.
At this point, the number and duration of appropriate contractions is primarily a matter of clinical judgement. The best advise seems to be to start with a "two-to-one" ratio if the muscles are weak. That is, instruct the patient to hold the yellow (rest) cycles for 6 seconds and the red (contract) ones for 3. Then as the patient improves over time, go to 8 (rest) and 6 (hold), and up to 10 and 10. Pay close attention to their relax durations. It is not unusual to observe the "yellow" segments getting progressively smaller, since many patients are preoccupied with strengthening their muscles and quickly forget about relaxing.
The red and yellow averages for the block of 25 contractions will be printed on the screen (and printer) at the end of the session. As experience accumulates, you may be able to use this data educationally. Eventually, the program will collect and display other potentially valuable statistics, such as the average latency to contract (how long it takes to get from the yellow line to the pink line) and average latency to relax (opposite measure). These numbers are likely to permit a whole new level of sophistication in analysis of Kegel exercise patterns.
Upon completion of the block of 25 prescribed Kegels, the program issues a congratulatory message and summary statistics. Pressing SPACEBAR will return you to the Menu Page. It is usually advisable to discuss the exercises with the patient at this point, and then prescribe another block of 25 before ending the day. This way the patient can observe the progress made in a single session of practice.
The number of blocks of 25 Kegels can be varied to suit scheduling convenience as well as patient needs. We caution against making office practice sessions too easy, however. The Kegel Exercises are not an alternative to "reading a good book" Ð they are an alternative to surgery, drugs, and the psychologically damaging effects of incontinence. We tell our patients "Sure you have to work hard now. But when you get your muscles back in shape, you'll be able to cut back to an easier maintenance level. The harder you work now, the sooner you'll get better."
NOTE: It is important not to make the criterion levels too high or low. Ideally, we want about an 80% success rate. If the goals which have been set or entered are too hard to obtain, you must presently stop the program (by pressing STOP and RESTORE at the same time, and then typing in the letters RUN <Return>. Then re-start the practice module, entering more realistic criterion levels. In a future edition this should be simplified. Also, the above procedure (STOP then RUN) should be repeated before each new patient, to ensure that all variables are cleared to zero.
Notes:
1. The location of the EMG channel is specified in line 920 of the program as "C = 6 ". If your EMG is located on a different channel, proceed as follows: 1. When the title page is displayed, press STOP and RESTORE keys simultaneously. This results in a blank screen with "READY" showing. Type in List 920<Return> This prints line 920. Using the cursor keys perhaps with shift, place the cursor over the number "6" and type in its place a new number corresponding to the channel used by your EMG module. While the cursor is still on line 920, press <return>. Then type this line: GOTO 10000<Return>. This will SAVE the change, VERIFY the saved change, and RUN the program with your new channel number permanently in place. The whole process takes a few minutes, but need not be repeated unless you make another permanent change in EMG channels. See the Title Page instructions for making a temporary change in channel assignment.
Appendix
The J&J Manuals for (1) the I-300 Interface unit and (2) the M501 EMG module are included with the modules. Most of the information is technical and not especially relevant in this application. However, your attention is called to the sections dealing with (1) Static Electricity problems, (2) Electrical Safety and (3) the dangers of connecting instruments to the computer when its power is on. (This does not include connecting patients to the EMG module, however. That's OK.) Note also that the normal position for the two switches on the back of the M501 module is "UP".
TIP: If you are giving a demonstration of the EMG Perineometer and holding it in the crotch of your hand to simulate EMG signals, you may find it difficult to relax your hand to a "normal" level of 1-2 µV without dropping the sensor. If you put the bottom switch on the EMG "down", you'll multiply the displayed values by 10, and give a more impressive demonstration. But one word of warning: Don't forget to return the switch to its normal position after the demonstration, or you may totally mis-diagnose your subsequent patients, with serious consequences!
In addition, please note the section concerning background noise testing with the dummy electrode assembly. We recommend using this to test for electrical interference. Note that the interface should be kept 1 to 2 feet away from the computer.
Moreover, anything connected to the interface should also be kept a couple of feet away from the computer Ð including the patient! One common violation of this rule occurs when the patient's feet are too close to the video monitor. If there is a poor "reference" lead connection and the patient's feet are close to the monitor, there will be pick-up of electromagnetic radiation from the screen which shows up as background noise (high resting tension) which gets higher as the screen gets "brighter" [i.e., as more lines are plotted on each screen graph.] If this happens, move the patient and monitor farther apart.
This page is http://www.incontinet.com/articles/art_urin/HOPCP300.htm
Copyright 1996 by John D. Perry
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