PD REHAB Trial Update

Cally Rick

8th June 2010

PD REHAB

Randomised controlled trial to assess the

clinical- and cost-effectiveness of

physiotherapy and occupational therapy in

Parkinson's disease.

PD REHAB Design

750 participants

40 centres

Randomised between PT & OT (starting

within 4 weeks) versus no therapy.

Follow up 15 months

PD REHAB Participants

Inclusion Criteria

Idiopathic PD defined by the UK PDS Brain Bank

Criteria

Report limitations in activities of daily living

The investigator is uncertain that the patient will require

OT and/or PT during the 15 months of the trial

Exclusion Criteria

Dementia as usually defined clinically by the patient’s

physician.

Received OT or PT in the last one year

PD REHAB Assessments

Measure Completed Assessment time

by Baseline 3 months 9 months 15 months

Hoehn and

Yahr stage Clinician

Medication Clinician

NEADL Patient

PDQ 39 Patient

EQ 5D Patient

Resource use

questionnaire Patient

Carer SF 12 Carer

PD REHAB Assessments (2)

Active treatment arm

Therapists logs:

Initial assessment logs

Treatment logs for each subsequent visit.

Please also complete logs for any participants in the

control group who cross-over.

PD REHAB AEs & SAEs

Given that PD REHAB is a extremely low risk trial, we

are recording a limited range of AEs & SAEs:

Falls

Equipment failure

Serious enough to require medical attention, either GP,

ambulance or hospital visit.

We will request further information on being informed by

the participants of any of these events occuring.

PD REHAB Governance

Substantial amendments were submitted in April 09

and March10.

Amendments are primarily* modifications to paperwork

that do not affect the day to day management of trial.

A further amendment will be submitted which will

include letters of invitation for potential participants.

* Except change to exclusion criteria in April 09

PD REHAB Approved Sites

City Hospital, Birmingham

QE Hospital, Birmingham

Harrogate District Hospital

Yeovil District Hospital

Eryri Hospital, Caernarfon

Southampton General Hospital

St Helens/Whiston Hospital

Royal Preston Hospital

Royal Hampshire County Hospital

Royal Bournemouth General Hospital

Macclesfield Hospital

Taunton & Somerset Hospitals (Musgrove Park)

Hereford District General

Royal Devon & Exeter Hospital

Mount Gould Hospital (Plymouth Teaching

Hospitals)

Darlington Hospital

Torbay Hospital

Gloucestershire Royal Hospital

Aberdeen Royal Infirmary

Lincoln County Hospital

Salisbury District Hospital

Central Middlesex Hospital, London

Grantham District Hospital

Heartlands Hospital, Birmingham

Dorset County Hospital

Poole Hospital

William Harvey Hospital

Leicester General Hospital

Watford General Hospital

Queen Alexandra Hospital Portsmouth

Princess of Wales Hospital

Walton Centre for N+N

PD REHAB Approved Sites

Awaiting R&D approval

Norfolk & Norwich University Hospitals

Edith Cavell Hospital, Peterborough

Royal Blackburn Hospital

Completing local application

Addenbrookes (/Newmarket/West Suffolk) Hospital

National Hospital for Neurology & Neurosugery

Bronylls Hospital

Fairfield Hospital, Bury

Hull Royal Infirmary

+ 2 possible sites

PD REHAB Recruitment

Patient Recruitment

0

5

10

15

20

25

30

Jul-09 Aug-

09

Sep-

09

Oct-

09

Nov-

09

Dec-

09

Jan-

10

Feb-

10

Mar-

10

Apr-

10

May-

10

0

10

20

30

40

50

60

70

80

90

100

Recruitment

Cumulative

Recruitment by Site

0

1

2

3

4

5

6

7

8

9

10

11

12

Pa

rtic

ipa

nts

Centre

PD REHAB Projections

Projections calculated for

32 sites. If 40 sites are

active, the final

projections are:

575 participants @6 or

962 participants @10

per site per year.

0

100

200

300

400

500

600

700

800

Jul-0

9

Sep-0

9

Nov-09

Jan-1

0

Mar

-10

May

-10

Jul-1

0

Sep-1

0

Nov-10

Jan-1

1

Mar

-11

May

-11

Jul-1

1

Sep-1

1

Nov-11

Jan-1

2

Mar

-12

May

-12

Projection @6

Projection @10

Actual

Further Sites

We are still accepting further sites that are keen to be

involved with the trial on an individual basis.

PD GEN

A substantial amendment to the PD GEN DNA bank

protocol has been approved to allow participants in

PD REHAB and their carers to provide PD GEN

samples.

Sites need ethical approval for PD GEN as well as PD

REHAB

PD REHAB Support

Website http://www.pdrehab.bham.ac.uk/

Therapists forum

PPI Panel

Site visits

Contact us:

Cally Rick, Francis Dowling, Ryan Ottridge,

Dani Scott & David Hingley.

0121 415 9125 / 9127 / 9128 or 9129

pd-trials@bham.ac.uk

Thank You