Contact information
Type
Scientific
Primary contact
Prof Rob de Bie
ORCID ID
Contact details
PO Box 616
Maastricht
6200 MD
Netherlands
+31 (0)43 388 2366
RA.deBie@EPID.unimaas.nl
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N/A
Study information
Scientific title
Acronym
Paratonia
Study hypothesis
Paratonia is a form of hypertonia with an involuntary variable resistance during passive movement. The nature of paratonia may change with progression of the dementing illness (e.g. active assistance (mitgehen) is more common early in the course of degenerative dementias, whilst active resistance is more common later in the course of the disease). The degree of resistance varies depending on the speed of movement (e.g. a low resistance to slow movement and a high resistance to fast movement). Paratonia increases with progression of dementia. Furthermore, the resistance to passive movement is in any direction and there is no clasp-knife phenomenon. The resistance must be felt in either two directions in one limb or in two different limbs.
The hypotheses of this trial are:
1. Is passive movement therapy an effective intervention on the severity of paratonia in comparison with usual care without passive movement therapy?
2. Is passive movement therapy an effective intervention for improvement of daily care?
3. Is there a difference in side effects of passive movement therapy versus care as usual in patients with moderate to severe paratonia?
Please note the anticipated start and end dates have been altered - the initial start date was 01/01/2007 and end date was 31/12/07, the target number of participants has also been updated to show the final recruitment number. Inclusion criteria have also been updated
Ethics approval
CMO region Arnhem-Nijmegen Radboud University Nijmegen has approved this trial on the 10th April 2007 (CMO nr. 2006/157, ABR dossier number NL13777.091.06).
Study design
Multi-centre interventional randomised single-blind study
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Other
Trial type
Treatment
Patient information sheet
Condition
Paratonia in dementia
Intervention
We propose a randomised controlled trial with a four week follow-up period. After computerised and concealed block randomisation (block-size of four) patients will be included in one of two groups. The first group will receive Passive Movement Therapy (PMT), the second group will receive usual care without PMT.
PMT will be given three times a week (between 8 a.m. and 10 a.m. shortly before washing and dressing) for four weeks in a row. Usual care (given to both groups) is mainly a combination of good stabilising cushions and a special care protocol called Passivity of Daily Life (PDL).
Intervention type
Other
Phase
Not Specified
Drug names
Primary outcome measure
Modified Ashworth scale - a five-point scale from zero to four, in which:
Zero = no resistance to passive movement
One = slight resistance during passive movement
Two = more marked resistance to passive movement
Three = considerable resistance to passive movement
Four = severe resistance, passive movement is impossible
Secondary outcome measures
1. The Pain Assessment Checklist for Seniors with Limited Ability to Communicate (PACSLAC)
2. To assess pain as a possible side effect of PMT
3. The Clinical Global Impressions (CGI) to assess the clinical improvement and a derived form of the Patient Specifieke Klacht (PSK) assessment in which the carers are asked to address the three most difficult items in daily care and rate these items on a ten point rating scale
Overall trial start date
01/04/2007
Overall trial end date
30/04/2009
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
1. Patients with dementia (according to the Diagnostic and Statistical Manual of Mental Disorders fourth edition [DSM-IV-TR] Criteria) and paratonia with a score on the modified Ashworth scale of two or more in one of the limbs are included in the study. Patients are only included after Proxy consent.
Added 28/07/09:
2. Male or female
3. Age range at close of recruitment was 67-98 (mean 84)
Participant type
Patient
Age group
Senior
Gender
Both
Target number of participants
98 patients from 12 different elderly health care institutions (final recruitment 101, 83 female, 18 male)
Participant exclusion criteria
1. Patients with an unstable disease like progressive malignant cancer or other diseases with an obvious progressive negative effect on the motor function
2. Patients who receive passive movement therapy prior to admission
3. The nursing home physician can decide to withdraw a participant from the study for urgent medical reasons
Recruitment start date
01/04/2007
Recruitment end date
30/04/2009
Locations
Countries of recruitment
Netherlands
Trial participating centre
PO Box 616
Maastricht
6200 MD
Netherlands
Sponsor information
Organisation
The Caphri Institute (The Netherlands)
Sponsor details
Maastricht University
Universiteitssingel 40
Maastricht
6200 MD
Netherlands
+31 (0)43 388 2446
D.Moens@CAPHRI.unimaas.nl
Sponsor type
University/education
Website
Funders
Funder type
Other
Funder name
The Vitalis Care Group (Vitalis Zorg Groep), Eindhoven (Netherlands)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Basic results (scientific)
Publication list
1. 2007 protocol in http://www.ncbi.nlm.nih.gov/pubmed/18093298
2. 2012 results in http://www.ncbi.nlm.nih.gov/pubmed/22185768
Publication citations
-
Results
Hobbelen JH, Tan FE, Verhey FR, Koopmans RT, de Bie RA, Passive movement therapy in severe paratonia: a multicenter randomized clinical trial., Int Psychogeriatr, 2012, 24, 5, 834-844, doi: 10.1017/S1041610211002468.
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Hobbelen JS, Verhey FR, Bor JH, de Bie RA, Koopmans RT, Passive movement therapy in patients with moderate to severe paratonia; study protocol of a randomised clinical trial (ISRCTN43069940)., BMC Geriatr, 2007, 7, 30, doi: 10.1186/1471-2318-7-30.