A research
study was conducted by investigators at the University of Minnesota in
collaboration with the staff of the Courage Centre, Golden Valley, Minnesota, to
evaluate the efficacy of the Adeli Suit on individuals with cerebral palsy or who had suffered a stroke. The suit
is an adaptation of the one worn by cosmonauts inside the space station to
prevent the effects of weightlessness on bone density and muscle mass. Professor
Arnold S. Barer of the Zvezda Corporation in Moscow who was one of the
developers of the Adeli Suit, along
with two Russian physical therapist physicians Drs. Galina Illitcheyva and
Leonid Razgon, carried out the treatment with the help
of Courage Centre physical therapists or trainees
and Russian interpreters. The study was approved by the University of Minnesota
Committee on the use of human subjects. The pilot test was conducted on six
patients over the period of June 30 to July 18, 1997. A follow-up took place
four weeks later on August 14, 1997.
A pool of
potential treatment subjects was selected by Ms. Paulette Olsen, Program Director Adult
Rehabilitation Service at the Courage Centre, with the approval of the patients'
physicians. Before selection into the study, each patient in the subject pool
who had an interest in participating and the time available
was personally interviewed by Dr. Barer together with Drs. Illitcheyva and
Razgon. These Russian physicians also reviewed the medical records and observed
the individual's mobility and co-ordination. Following this step in the
screening process, patients were administered the Vocabulary and Comprehension
subtests of the Wechsler Intelligence Scale for Children - Third Edition (WISC -
III) or the Wechsler Adult Intelligence Scale - Revised (WAIS - R), as
appropriate for their age. The purpose was to assess whether the patient
understood and agreed to the treatment procedures, and was able to communicate
in the eventuality he or she felt pain or at a later time wished to terminate
treatment. Subjects, and their parents (in the case of minors), also signed
consent forms indicating their agreement to participate in this investigation.
Table 1
presents demographic and clinical data on each of the six subjects in this
investigation.
Measures
Prior to the
start of treatment, each subject was videotaped performing a standardised protocol for
walking and sitting. The videotape procedure was repeated at the following
intervals: Session 8, Session 13 (end of treatment), and at the four week
post-treatment follow-up. Two University of Minnesota Division of Kinesiology
graduate students carried out the timing, analysis, and evaluation of the video
recordings. The bio-mechanical instrumentation used was a well known motion
analysis system which compares various mobility
and co-ordination parameters. This technique allows
the comparison of individual videotape frames within a specific event, such as a
step length during walking to evaluate the variables in question. A
questionnaire was administered to participants and others at the end of
treatment and at the follow-up. The purpose was to obtain additional information
about mobility, co-ordination, mood and behavioural changes during treatment,
and the stability of these changes over the follow-up interval. The
end-of-treatment questionnaire was completed independently by the patient, a
designated caregiver, and both the Courage Centre and Russian therapists who
worked with the particular subject. At follow-up, the questionnaire was
completed by the subject, caregiver, and Courage Centre therapist, if available.
The follow-up questionnaire assessed changes from
pre-treatment baseline to the four week follow-up. Respondents also answered the
same questions reporting on the interval from the end of treatment to the
follow-up, with the aim of assessing stability of change or possible improvement
or decline in functioning over this time period. A
speech evaluation was conducted before the start of treatment and again on the
last day of treatment on two participants with speech problems.
Procedure
Treatment was
conducted on a daily basis, five days a week over a three week period. Treatment
began with approximately 20 minutes of massage, followed
by dressing the patient in the Adeli Suit and conducting the walking and various physical therapy exercises as
appropriate for the particular patient's ability level. Each therapy session was
approximately two hours in duration. Subjects were allowed to rest as needed and
drink water upon request.
Results
Questionnaire.
Cerebral Patsy Patients
The
reports of change over treatment and at the follow-up interval for the
participants with cerebral palsy are presented in
Table 2A, Table 2B
and Table 2C.
Examination of
these data indicate substantial consistency in judgements of pre- to
post-treatment progress among the subject, caregiver,
and Courage Centre and Russian therapists. Each of the informants reported
improvement in the following for all patients: arm function, leg function,
ability to stand without help, walking with less swaying, purposeful movement,
ability to hold objects. Overall
positive change in emotions, improvement in confidence, stamina, and better
sleep were noted by some. Improvement in clarity of speech in the
two patients with speech problems, and better communication with other persons
in the CP patient group as a whole were reported.
Table 2 also
documents that at the four week follow-up, the various
respondents indicated that these improvements were maintained, and in some cases
progressed further.
The
questionnaire findings for the three stroke patients are presented in
Table 3A, Table
3B and Table 3C. The findings are
similar to that observed with the cerebral palsy patients.
Examination of
Table 3 demonstrates substantial agreement among
various informants regarding improvement on the various indices of motor
performance. In addition to these changes in motor
function and co-ordination, informants noted beneficial
psychological changes such as a more positive mood, and greater confidence
and ability to communicate with others. The
follow-up evaluation indicated that the change on the various indices evaluated
was maintained over the four week interval.
Figures
1, 2,
3, 4,
5, 6 are
graphs demonstrating several variables describing patterns of motion, evaluated
at pre-treatment (baseline), end of treatment (final), and follow-up. A large
number of movement variables were evaluated; the several indices presented on
these figures indicate areas in which the relatively
greatest improvement was noted for a particular subject. Horizontal velocity of
the hip is measured while subjects are moving in a forward direction. It
assesses changes in speed over a given distance, and is a measure of the amount
of breaking and acceleration while walking. A smoother line indicates less
variability. Wrist velocity measures the amount of movement of the wrist while
walking. In this case, greater wrist velocity in
someone with a paralysed arm demonstrates an
improvement in function. Angular displacement of the trunk is a measure of whether
the subject is walking in an upright,
forward-leaning, or backward-leaning direction. A
90° angle is the upright position; less than 90° indicates leaning forward;
greater than 90° indicates leaning backwards.
Cerebral Palsy
Patients
Figures 1-3
present the horizontal velocity of the hip while
moving forward for Subject 1,
Subject 2 and
Subject 3. In all cases, the
data demonstrate less variability while walking comparing baseline to end of treatment,
thus indicating much better control in gait
pattern. This was maintained at follow-up.
Stroke Patients
Wrist velocity
for Subject 4 assessing changes in the movement of her paralysed arm indicated
improvement over the course of treatment, as well as from pre-treatment to
follow-up. The angular displacement of the trunk data on
Subject 5 is noteworthy
in terms of the reduction over the course of treatment in leaning forward and
backwards while walking. The horizontal velocity of the hip data for
Subject 6
is consistent with the findings of the CP patients in demonstrating improvement
over the course of treatment and maintenance at follow-up.
Speech
Evaluation
Speech
evaluations were carried out on Subjects 2 (CP) and 5 (stroke). Both subjects
were evaluated at three intervals: pre-treatment, end of Week 2, and end of Week
3. The ability of Subject 2 to sustain phonation (prolongation of sound)
increased over the three sessions. At the end of treatment, his sustained
phonation ability was similar to that of an average adult. Word intelligibility
increased but sentence intelligibility decreased over the course of treatment.
The speech therapist noted an apparent improvement in speech and language skills
in Subject 5 over the course of the study.
Conclusions
The
Adeli Suit treatment program is
very intensive and concentrated over a three week period, but in the long run,
may prove to be highly cost-effective. Our observations indicated that the
patients noticed some improvement in motor function in the combined procedure in
each session of intensive massage followed by
therapy in the Adeli Suit. This
positive feedback motivated the individual to work hard during subsequent
treatment sessions and between sessions, thus, the
commitment to follow through with the program
increases over the treatment interval, and the patient develops greater stamina.
The positive changes in motor function after such combined massage and suit
therapy procedures also enhanced mood and self-confidence. After the completion
of treatment, the training in how to hold one's body and walk in a more
normalised manner appears to be maintained or continues to improve because the
patients now practice and exercise on their own.
Thus, the combination of better motor function that is noted early in treatment,
apparent re-training of sensory-motor centres of the brain, and increased
self-confidence and motivation to maintain and enhance positive changes, all
work in a synergistic manner in promoting patient
improvement.
The study
findings strongly indicate that further treatment research and follow-up with a
greater number of patients and with younger children is warranted in order to
make firmer conclusions about the efficacy of the Adeli Suit. There were no
side-effects or complications noted as a result of treatment. The brains of
younger children are more malleable and the quality of their lives might be
substantially improved over the relatively more extended time of their lives
with effective treatment.
