A randomised clinical trial of passive movement therapy in patients with moderate to severe paratonia

ISRCTN ISRCTN43069940
DOI https://doi.org/10.1186/ISRCTN43069940
Secondary identifying numbers N/A
Submission date
18/10/2006
Registration date
04/12/2006
Last edited
17/08/2012
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Mental and Behavioural Disorders
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Prof Rob de Bie
Scientific

PO Box 616
Maastricht
6200 MD
Netherlands

Phone +31 (0)43 388 2366
Email RA.deBie@EPID.unimaas.nl

Study information

Study designMulti-centre interventional randomised single-blind study
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Other
Study typeTreatment
Scientific title
Study acronymParatonia
Study objectivesParatonia 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(s)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).
Health condition(s) or problem(s) studiedParatonia in dementia
InterventionWe 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 typeOther
Primary outcome measureModified 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 measures1. 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 study start date01/04/2007
Completion date30/04/2009

Eligibility

Participant type(s)Patient
Age groupSenior
SexBoth
Target number of participants98 patients from 12 different elderly health care institutions (final recruitment 101, 83 female, 18 male)
Key inclusion criteria1. 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)
Key exclusion criteria1. 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
Date of first enrolment01/04/2007
Date of final enrolment30/04/2009

Locations

Countries of recruitment

  • Netherlands

Study participating centre

PO Box 616
Maastricht
6200 MD
Netherlands

Sponsor information

The Caphri Institute (The Netherlands)
University/education

Maastricht University
Universiteitssingel 40
Maastricht
6200 MD
Netherlands

Phone +31 (0)43 388 2446
Email D.Moens@CAPHRI.unimaas.nl
Website http://www.caphri.nl/
ROR logo "ROR" https://ror.org/02jz4aj89

Funders

Funder type

Other

The Vitalis Care Group (Vitalis Zorg Groep), Eindhoven (Netherlands)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing plan

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
Protocol article protocol 19/12/2007 Yes No
Results article results 01/05/2012 Yes No