Determine the reliability, validity and the sensitivity to change of the MYOTON Handheld Digital Palpation Device for measuring the severity of paratonia in patients with dementia and paratonia .Research questions are:(1) What is the validity of the…
ID
Source
Brief title
Condition
- Muscle disorders
- Movement disorders (incl parkinsonism)
- Dementia and amnestic conditions
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Primary outcomes:
-Muscle tone, elasticity, creep, stiffness, mechanical stress relaxation
assessed with the Myoton
-Muscle tone/paratonia severity assessed with the Modified Ashworth Scale
-Muscle tone and stiffness assessed by palpation of the muscles
Secondary outcome
The presence or absence of paratonia assessed with the Paratonia Assessment
Instrument.
Background summary
Muscle hypertonia, movement stiffness and loss of elasticity are phenomena
often seen in patients with dementia. One of the causes of movement stiffness
is paratonia. When measuring the presence or absence of Paratonia, the
Paratonia Assessment Instrument (PAI) is a reliable instrument and the golden
standard for diagnosing paratonia. The severity of paratonia is scored by using
the Modified Ashworth Scale (MAS). In clinical settings the MAS is the
worldwide standard as a rating scale to measure abnormality in tone or the
resistance to passive movements. Because the assessor has to judge the muscle
tone by the perceived resistance during passive movement, the measurement is
prone to subjectivity and extensive clinical experience is necessary for the
MAS to become reliable. In assessing resistance during passive movement as with
the MAS, it remains unclear which of the muscle properties such as tone,
elasticity, creep, stiffness or mechanical stress relaxation are perceived by
the assessor. For assessing and evaluating therapeutic interventions objective
measurements of muscle properties are required. New measurements, such as the
MYOTON Handheld Digital Palpation Device, were developed and showed to be more
sensitive and precise than the MAS to quantify muscle properties. The
myotonometer has been validated in patients with stroke and upper motoneuron
disorders. Also it has proven a reliable measurement in patients with stroke,
Parkinson*s disease, in children with cerebral palsy and healthy subjects.
However, the validity and reliability of the myotonometer has yet to be
investigated in patients with paratonia and dementia.
This study aims to determine the concurrent validity against the MAS, criterion
validity against the PAI, the reliability (inter and intra) and sensitivity for
change of the Myoton Handheld Digital Palpation Device in dementia patients
with paratonia
Study objective
Determine the reliability, validity and the sensitivity to change of the MYOTON
Handheld Digital Palpation Device for measuring the severity of paratonia in
patients with dementia and paratonia .
Research questions are:
(1) What is the validity of the MYOTON in measuring severity of Paratonia ?
(2) Which of the MYOTON measured muscle properties (tone, elasticity, creep,
stiffness, mechanical stress relaxation) correlate strong with Paratonia ?
(3) Is the MYOTON reliable when repeating the measurement by another assessor
on the same session (inter-observer reliability)?
(4) Is the MYOTON reliable or reproducible over time (i.e intra-observer
reliability and absolute measurement error)?
(5) Is the MYOTON sensitive to change for paratonia severity after 6 months?
Study design
A longitudinal observational cohort study with a 6-months follow-up in 168
patients with dementia.
A total of 4 assessments will be performed at home, in day-care centres and
nursing homes; at baseline 3 assessment (T0 by assessor 1, T0 by assessor 2 and
30 minutes later a second T0 by assessor 1), and after 6 months 1 assessment
(T1 by assessor 1).
Because the incidence and severity of paratonia increases with the progression
of the dementia, we propose a cohort with three subgroups (1: early stage
dementia, 2: moderate stage dementia and 3: severe stage dementia).
Study burden and risks
Paratonia is a progressive form of hypertonia and only present in patients with
dementia. For this reason, this study regarding paratonia and the Myoton
validity and reliability can only take place with patients with an established
diagnosis of dementia. Earlier research showed that in early stage dementia the
prevalence of paratonia is 34.8% and the 1-year incidence is 38.3%. Patiënts
with early stage dementia live at home or are visiting day-care facilities with
guidance of a casemanager. This makes this settings suitable to include
dementia patients with and without paratonia. Prevalence of paratonia in later
stage dementia is up to 90- 100%. Later stage dementia patiënts often live in
nursing homes. There are no risks involved for the participants. Assessing
muscle tone and paratonia is often part of usual assessment. Measurement with
the Myoton only takes a few seconds and is painless and non-invasive.
Eyssoniusplein 18
Groningen 9714 CE
NL
Eyssoniusplein 18
Groningen 9714 CE
NL
Listed location countries
Age
Inclusion criteria
- Community dwelling dementia patients with an established diagnosis according to the DSM IV/DSM V criteria and a GDS score of 2,3 or 4 (= Early stage dementia)
- Institutionalized dementia patients with an established diagnosis according to the DSM IV/DSM V criteria and a GDS score of 5 or 6 (=Moderate stage dementia)
- Institutionalized dementia patients with an established diagnosis according to the DSM IV/DSM Vcriteria and a GDS score of 7 (= Severe stage dementia)
(The GDS is a 7-point scale indicating the severity of cognitive and functional decline in dementia with 1 No subjective complaints of memory deficits, 2 Subjective complaints, 3 Earliest clear-cut deficits, 4 Clear-cut deficits, 5 Patient can no longer survive without some assistance, 6 Largely unaware of all recent events and require assistance with activities of daily living, 7 Basic psychomotor skills and verbal ability are lost and require assistance in toileting and feeding).[
- Signed informed or proxy consent
Exclusion criteria
- Unstable health due to an interfering comorbidity.
- Using first generation psychotropic drugs, as these drugs can possibly mimic paratonic rigidity
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL54144.042.15 |