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

Completed

Conditions: Paratonia in dementia
Mental and Behavioural Disorders
Dementia

Registration Number: ISRCTN43069940

Lead Sponsor: The Caphri Institute (The Netherlands)

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: All

Target Recruitment: 98

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)

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

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Modified Ashworth scale - a five-point scale from zero to four, in which:<br>Zero = no resistance to passive movement<br>One = slight resistance during passive movement<br>Two = more marked resistance to passive movement<br>Three = considerable resistance to passive movement<br>Four = severe resistance, passive movement is impossible

Secondary Outcome Measures

Name	Time	Method
1. The Pain Assessment Checklist for Seniors with Limited Ability to Communicate (PACSLAC)<br>2. To assess pain as a possible side effect of PMT<br>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