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

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN43069940
Enrollment
98
Registered
2006-12-04
Start date
2007-04-01
Completion date
Unknown
Last updated
2015-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Paratonia in dementia Mental and Behavioural Disorders Dementia

Interventions

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. Th

Sponsors

The Caphri Institute (The Netherlands)
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

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

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

Design outcomes

Primary

MeasureTime frame
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

MeasureTime frame
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

Countries

Netherlands

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Apr 6, 2026