Primary objective: The main research issue here is whether the intervention with the mirrorfeedback in patients with motor conversion of the arm or hand leads to improvement handgrip strength.Secondary objectives: The secondary research question is…
ID
Source
Brief title
Condition
- Somatic symptom and related disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Gripstrength with the Jamar hand Meter
Using a Handheld Digital Jamar dynamometer, the maximum hand grip strength will
be measured daily in the affected hand. The grip strength is expressed
digitally (kilograms). The dynamometer is a valid instrument for measuring hand
grip strength (Mathiowetz, 2002). In this study at each measurement point three
measurements are made, the highest score is taken. The interrater reliability
was .82 (Mathiowetz et al, 1984), where the highest of three readings is used.
The dynamometer is easy to use and the measurement takes little time (Bellac et
al, 2000).
Sensitivity to the Semmes Weinstein filaments
Using monofilaments, the sensibility of all the fingers are determined. Semmes
Weinstein filaments will be used, comprising a set of five different weights.
This measurement is performed according to the protocol provided by the test.
Although the test-retest reliability is better if the measurements are
performed by a single tester (Bell-Krotoski & Tomancik, 1987), the test-retest
reliability is also good for the five individual filaments as they are taken by
different testers.
Secondary outcome
Brunnstrom Fugl-Meyer Assessment (BFM)
The BFM is an instrument for handicrafts, which consists of 55 items scored on
an ordinal 3-point scale (0-2). The overall test consists of an examination of
the upper (hand and arm) and lower (leg and foot) limb and an examination of
the balance. In this study, only the items for the upper extremity are taken.
The maximum score for the upper extremity is 66. For the test area of the upper
extremity is a high interrater reliability (ranging from .86 to .95) found in
several studies (Sanford et al, 1993, Duncan et al, 1983). Construct validity
of various studies and compared with several motor sizes ranged from .54 to .94
for the total score for the upper extremity (Sanford et al, 1993).
Range of Motion (ROM)
The normal range of motion is a joint range of motion (ROM) called. It refers
to the amount of possible movement during non-assisted voluntary joint
movement. The movement is thus provided by an active contraction of the muscles
that span the joint. The opposition of the thumb to describe the degree of
opposition against the digiti I, II, III, IV, V, and metacarpal V. The score
ranges from 0 to 6.
Dissociative Experiences Scale (DES)
The DES (Carlson & Putnam, 1993, Bernstein & Putnam, 1986) is a self-report to
measure dissociative symptoms. The questionnaire was translated into Dutch and
Draijer by Boon (1993). The list includes 28 items and includes three factors:
absorption, amnesia and depersonalization. The patient is asked to indicate on
a visual analogue scale to indicate to what extent they experience dissociative
sypmtoms. Several studies (Dubester & Braun, 1995; Frischoltz et al, 1990,
Bernstein & Putnam, 1986) have shown that the realiability of the DES is very
high. The test-retest reliability ranges from .84 to .93. The reliability over
a period of one year showed relatively stable: .78 (Putnam et al, 1992). A
meta-analysis (and Schuengel IJzendoorn, 1996) showed that the convergent
validity is high compared to other lists and interviews and dissociation, the
DES has a high predictive validity.
Somatic Dissociation Questionnaire (SDQ-20)
The Dutch version of the SDQ-20 (Nijenhuis et al, 1996) is a self-report, which
measure somatoform dissociation. Item Scores run from 1 to 5 (absent to
severe). The reliability (Cronbach's α = .95) and the validity of the scale are
good (Nijenhuis et al, 1996). The criterion validity is strong. This is
evidenced by the strong discriminatory power of the SDQ-20 among patients with
a dissociative disorder (48.14, SD = 15.24) and a control group of general
psychiatric patients (23.5, SD = 3.97, p <.0001). The convergent validity
compared with the total score and three of the four scales of the DIS-Q is high
(.71
Background summary
The application of the mirror design has been shown in patients with phantom
pain, complex regional pain syndrome and people who had loss of motor function
after a stroke. In this study we want the applicability of the mirror structure
in patients with motor conversion studies. The effect of the mirror feedback in
motor conversion can be explained from different theoretical backgrounds
(cognitive dissonance, dissociation and mirror neurons). Also, the reflection
of the functioning hand or arm the system of mirror neurons can activate. In
addition, the structure generated by the mirror illusion can help the
dissociation of patients can break through.
Study objective
Primary objective: The main research issue here is whether the intervention
with the mirrorfeedback in patients with motor conversion of the arm or hand
leads to improvement handgrip strength.
Secondary objectives: The secondary research question is whether the mirror
design leads to improved sensitivity and increased the functionality of the
hand or arm. Another exploratory question focuses on whether there is evidence
from research that mirror the structure dissociation in patients with motor
conversion can be reduced.
Study design
A replicated randomized single-case AB design, with six patients treated. Such
designs are particularly appropriate when little is known about a treatment
method (such as mirror visual feedback) both with regard to the treatment
effect as the required training intensity. Because the outcomes of the patients
are repeatedly determined and a baseline measurement is performed, the patients
function as their own control (Bulte & Onghena, 2008, Guyatt et al, 1988; Brain
& Barlow, 1984). The baseline phase has the same goal as the untreated control
group in randomized controlled trials. If the behavior changes after the
baseline phase, it can be assumed that the intervention is responsible for this
change. Although this design does not allow the validity of the findings to the
public directly to determine the possibility of generalising considerably
strengthened when a similar effect is observed in several patients. Repetition
of the AB design in several patients strengthens the findings. The design of
such a study gives reliable results (for an overview see: Yin, 2003, Barlow &
Brain, 1984).
As with clinical trials, randomization in single-case experiments offers a
solution to control for (confusing) variables, with respect to time,
respondents and setting. Unlike randomized controlled trials (RCTs), the
randomisation in single-case designs not include random assignment to a
treatment condition. In single-case randomization experiments refers to the
purely accidental determining the time of the phase change. Random assignment
used in a single-case experiment, obtained on time-based statistical control
known and unknown variables. This makes possible a statistical test based on
randomization, as in the study design is applied (Ter Kuile et al, 2009,
Onghena & Bulte, 2008). To avoid that random distribution would lead to too
little (or no) measurement dates in one of the two phases of a limited
randomized phase change is recommended, with a minimum number of measurement
dates for each phase is fixed in advance (Bulte & Onghena, 2008) .
The total duration of the study covers seven weeks, with included clinical
patients. On the weekends, patients go home (total of 35 working days remain)
The baseline phase (A) consists of no treatment and the experimental phase (B)
consists of two weeks daily intervention and a possible follow-up period. The
start of the experimental phase B (start intervention) for each participant on
a purely fortuitous manner determined with the restriction that the baseline
phase A at least 1 week (five days) duration and each patient 2 weeks (10 days)
consecutive can practice with the mirror design. This means that intervention
can begin at any time between the second and sixth week (20 random).
The main outcome measure the strength and the sensitivity is measured daily
during the 7 weeks. Because the patients go home on weekends over a period of 7
weeks in total 35 times measured. In this way a comparison can be made in
outcome measures between the ranges of the baseline phase and the experimental
phase (Ter Kuile et al, 2009; Onghena & Bulte, 2008).
Randomization done with replacement. Because the baseline / control phase
lasts at least 5 days and everyone a block of ten days with the mirror design
exercise, so there remain twenty days (p =. 05) on the random assignment. The
study design is a schematic representation of the design. The table is not
included in the template.
Baseline (5 days)
Randomization (20 measuring days), P = 0.05
During this period (day 1 to day 20) is started with random intervention, in a
block of ten consecutive (measurement) days.
During the last 10 test days (day 21) could not be randomized.
In one patient, it might be that the fate that after the baseline measurements
of five straight starts with the intervention. There then follows a period of
ten days, when the protocol is practiced in the mirror design. Then the
practice stopped, but is measured daily. The period of twenty days following,
is the follow-up period. Patient 2, for example, randomly assigned to eight
days after the baseline measurement of five, starting with the intervention.
This patient has a total of 12 baseline measurements (fixed + five days seven
days assigned by lot) when no intervention takes place. Then started ten days
in which the established practice with the mirror setup, after which a period
of thirteen days follow-up follows.
Intervention
The intervention includes the addition of practice with the mirror up to the
retirement program. For patients with an affected arm or hand mirror
arrangement consists of a vertically positioned mirror that stands between two
tables. The healthy and the affected arm to either side of the mirror on the
table. The mirror is directed to the poor functioning. The affected arm is
shielded, so that these patients are not visible. When the patient looks in the
mirror, he sees two arms: the arm functioning and it reflected. Asked the
healthy arm to move in the mirror at a reflection of the moving arm. The
reflection of the healthy arm creates the illusion that the affected arm move
symmetrically along with the healthy arm.
For practicing with the mirror up in the experimental phase, a training
protocol was developed. Patients are practicing five times a day for ten
consecutive days with. Each training session lasts twenty minutes. Where, in
the experimental phase starts with the mirror structure is determined by
randomization, as previously described. There is a time twenty minutes
practicing with a fixed practisingprotocol.
Study burden and risks
Patients participating in the study are treated following the regular
treatmentprogram for patients. The first phase of clinical treatment consists
of deactivation. This phase is important in the treatment of motor conversion
disorder, because often these patients show long lasting patterns of
overburdening. This program requires that patients participate in non-treatment
activities in the clinical group, such as meals and coffee. During the
low-stimulus program, no treatment modules offered. The rationale behind this
program is often the chronic overloading of patients to quit. Many patients do
not register bodily or ignore these signals. This is often an important
maintaining factor in the disorder. Discontinuation of activities is an initial
attempt to reconnect with the physical signals. Patients are asked to record
the physical signals. This is monitored by a physiotherapist. This is the main
goal in this phase of treatment. The duration of the low-stimulus program is
four weeks, depending on the load of the patient. In later stages of the
regular treatment graded activity is added, using physical signals to
discriminate the limits of activation. During the low-stimulus program patients
can participate in the creative actvities, with the aim of leisurement.
As part of this research, the procedures described below was added to the
standard treatment offer.
• During the low-stimulus program, somewhere between week 2 and week 6 for ten
days twenty minutes five times a day practicing with the mirror structure
according to the exercise routine. Both the training protocol as the mirror
arrangement already described in Section 6.1.
• grip strength and sensibility are determined on a daily base (35
measurements)
• Weekly, the dissociative symptoms are measured by a psychological assistant
and functional dimensions measured.
The risk to patients is negligible. The mirror structure has little negative
side effects. Only in a study of Moseley Meaningless sensory experiences are
described, which disappear when the intervention was ceased.
Wijnkoperstraat 2
4204 HK Gorinchem
NL
Wijnkoperstraat 2
4204 HK Gorinchem
NL
Listed location countries
Age
Inclusion criteria
• Six patients who meet the criteria for a motor conversion disorder according to the DSM-IV classification.
• Patients participating in the low-stimulus program, which is part of the regular treatment
• The motorconversion of the arm is monosymtpomatic (paresis or paralysis)
• Symptoms last between two months and two years.
• Age is between 18 and 65 years.
• Patients are motivated for treatment.
• Sufficient knowledge of Dutch language.
Exclusion criteria
• Co-existence of a somatic condition that influences the conversion disorder
• Psychotic symptoms.
• Mental retardation
• Concurrent treatment for conversion disorder in a different setting.
• A condition which makes patients unsuitable for study participation, according to the researchers
Design
Recruitment
Medical products/devices used
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In other registers
Register | ID |
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CCMO | NL34890.097.11 |