A randomised clinical trial of passive movement therapy in patients with moderate to severe paratonia
ISRCTN | ISRCTN43069940 |
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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
Scientific
PO Box 616
Maastricht
6200 MD
Netherlands
Phone | +31 (0)43 388 2366 |
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RA.deBie@EPID.unimaas.nl |
Study information
Study design | Multi-centre interventional randomised single-blind study |
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Primary study design | Interventional |
Secondary study design | Randomised controlled trial |
Study setting(s) | Other |
Study type | Treatment |
Scientific title | |
Study acronym | Paratonia |
Study objectives | 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(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) studied | 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 |
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 study start date | 01/04/2007 |
Completion date | 30/04/2009 |
Eligibility
Participant type(s) | Patient |
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Age group | Senior |
Sex | Both |
Target number of participants | 98 patients from 12 different elderly health care institutions (final recruitment 101, 83 female, 18 male) |
Key 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) |
Key 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 |
Date of first enrolment | 01/04/2007 |
Date of final enrolment | 30/04/2009 |
Locations
Countries of recruitment
- Netherlands
Study participating centre
PO Box 616
Maastricht
6200 MD
Netherlands
6200 MD
Netherlands
Sponsor information
The Caphri Institute (The Netherlands)
University/education
University/education
Maastricht University
Universiteitssingel 40
Maastricht
6200 MD
Netherlands
Phone | +31 (0)43 388 2446 |
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D.Moens@CAPHRI.unimaas.nl | |
Website | http://www.caphri.nl/ |
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 | |
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Individual participant data (IPD) Intention to share | No |
IPD sharing plan summary | Not provided at time of registration |
Publication and dissemination plan | Not provided at time of registration |
IPD sharing plan |
Study outputs
Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
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Protocol article | protocol | 19/12/2007 | Yes | No | |
Results article | results | 01/05/2012 | Yes | No |