Condition category
Mental and Behavioural Disorders
Date applied
18/10/2006
Date assigned
04/12/2006
Last edited
17/08/2012
Prospective/Retrospective
Prospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

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 measures

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

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

http://www.caphri.nl/

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

Results - basic reporting

Publication summary

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

  1. 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.

  2. 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.

Additional files

Editorial Notes