Condition category
Nervous System Diseases
Date applied
27/06/2005
Date assigned
10/08/2005
Last edited
16/09/2009
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Carl Clarke

ORCID ID

Contact details

Department of Neurology
City Hospital
Dudley Road
Birmingham
B18 7QH
United Kingdom
+44 (0)1215074073
c.e.clarke@bham.ac.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

Acronym

The PD OT Trial

Study hypothesis

Community occupational therapy has beneficial effects upon functional independence, mobility and quality of life in patients with Parkinson's disease when compared to no occupational therapy intervention

Ethics approval

Not provided at time of registration

Study design

Randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Other

Trial type

Treatment

Patient information sheet

Condition

Parkinson's Disease

Intervention

Occupational therapy compared to no occupational therapy

Intervention type

Other

Phase

Not Specified

Drug names

Primary outcome measures

Functional ability

Secondary outcome measures

1. Mobility
2. Disability
3. Quality of Life

Overall trial start date

01/07/2005

Overall trial end date

30/06/2006

Reason abandoned

Eligibility

Participant inclusion criteria

1. Idiopathic Parkinson's disease (PD) defined by the UK PDS Brain Bank Criteria
2. Patients with more severe PD - those with Hoehn and Yahr stages III and IV

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

50

Participant exclusion criteria

1. Dementia (as usually defined by the Investigator) - the patient must be capable of completing self-assessment forms
2. Received occupational therapy in the last 2 years and/or physiotherapy in the last year

Recruitment start date

01/07/2005

Recruitment end date

30/06/2006

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Department of Neurology
Birmingham
B18 7QH
United Kingdom

Sponsor information

Organisation

University of Birmingham (UK)

Sponsor details

Medical School
Edgbaston
Birmingham
B15 2TT
United Kingdom
+44 (0)1214148188
stuart.cumella@bham.ac.uk

Sponsor type

University/education

Website

Funders

Funder type

Charity

Funder name

Parkinson's Disease Society (UK) (Ref: 8041)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

2009 results in http://www.ncbi.nlm.nih.gov/pubmed/18339727

Publication citations

  1. Results

    Clarke CE, Furmston A, Morgan E, Patel S, Sackley C, Walker M, Bryan S, Wheatley K, Pilot randomised controlled trial of occupational therapy to optimise independence in Parkinson's disease: the PD OT trial., J. Neurol. Neurosurg. Psychiatr., 2009, 80, 9, 976-978, doi: 10.1136/jnnp.2007.138586.

Additional files

Editorial Notes