Passive movement therapy in patients with moderate to severe paratonia; study protocol of a randomised clinical trial (ISRCTN43069940)

Johannes SM Hobbelen¹^,2 , Frans RJ Verhey³ , Jacobus HJ Bor⁴ , Rob A de Bie²^,5 and Raymond TCM Koopmans⁴

¹Physiotherapy Research Vitalis WoonZorg groep Eindhoven, The Netherlands

²School for Public Health and Primary Care (CAPHRI), Maastricht University PO Box 616, 6200 MD Maastricht, The Netherlands

³University Hospital of Maastricht/Alzheimer Centre Limburg PO Box 5800, 6202 AZ Maastricht, The Netherlands

⁴Department of Nursing Home Medicine Radboud University Nijmegen Medical Centre P.O. Box 9101, 229 VPG 6500 HB Nijmegen, The Netherlands

⁵Department of Epidemiology, Maastricht University PO Box 616, 6200 MD Maastricht, The Netherlands

author email corresponding author email

BMC Geriatrics 2007, 7:30doi:10.1186/1471-2318-7-30


Published:	19 December 2007

Abstract

Background

Paratonia, a form of hypertonia, is associated with loss of mobility and with the development of contractures especially in the late stages of the dementia.

Passive movement therapy (PMT) currently is the main physiotherapeutic intervention. General doubt about the beneficial effects of this widely used therapy necessitates a randomised clinical trial (RCT) to study the efficacy of PMT on the severity of paratonia and on the improvement of daily care.

Methods/Design

A RCT with a 4-week follow-up period. Patients with dementia (according to the DSM-IV-TR Criteria) and moderate to severe paratonia are included in the study after proxy consent. By means of computerised and concealed block randomisation (block-size of 4) patients are included in one of two groups. The first group receives PMT, the second group receives usual care without PMT. PMT is given according to a protocol by physical therapist three times a week for four weeks in a row. The severity of paratonia (Modified Ashworth scale), the severity of the dementia (Global Deterioration Scale), the clinical improvement (Clinical Global Impressions), the difficulty in daily care (Patient Specific Complaints) and the experienced pain in daily care of the participant (PACSLAC-D) is assessed by assessors blind to treatment allocation at baseline, after 6 and 12 treatments.

Success of the intervention is defined as a significant increase of decline on the modified Ashworth scale. The 'proportion of change' in two and four weeks time on this scale will be analysed. Also a multiple logistic regression analysis using declined/not declined criteria as dependent variable with correction for relevant confounders (e.g. stage of dementia, medication, co-morbidity) will be used.

Discussion

This study is the first RCT of this size to gain further insight on the effect of passive movement therapy on the severity of paratonia.

Trial registration

Current Controlled Trials ISRCTN43069940