PD REHAB Trial Recruitment . 6-10 patients per annum per investigator40 sites750 participants will be randomised36 months. PD REHAB Trial Inclusion criteria . Idiopathic PD defined by the UK PDS Brain Bank CriteriaReport limitations in activities of daily livingThe investigator is uncertain that the patient will require OT and/or PT during the 15 months of the trial.
1. A randomised controlled trial to assess the clinical- and cost-effectiveness of PT and OT in PD Cally Rick
2. PD REHAB Trial Recruitment 6-10 patients per annum per investigator
750 participants will be randomised
3. PD REHAB Trial 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
4. PD REHAB Trial Exclusion criteria Dementia as usually defined clinically by the patient’s physician.
Received OT or PT in the last one year
5. PD REHAB Trial Randomisation
6. PD REHAB Trial Consent Patients and carers will be given an explanation of the trial by their neurologist or geriatrician
Given a patient information sheet or carer information sheet to read
Time to decide whether they would like to join the trial
Then asked to sign consent forms
Patient’s GP will be informed in writing of the patient’s participation in the trial with the patient’s consent
7. PD REHAB Trial Randomisation
8. Baseline forms There are a number of forms to be completed at baseline by both the participant and the clinician/research nurse. These are in a pack including:
Patient Clinician Carer
NEADL Entry form SF12
PDQ39 Randomisation notepad
9. Information needed to randomise Log on & password
Hoehn & Yahr score
10. Scoring NEADL
11. Hoehn & Yahr Stage 1.0 Unilateral involvement only
Stage 1.5 Unilateral and axial involvement
Stage 2.0 Bilateral involvement without impairment of balance
Stage 2.5 Mild bilateral involvement with recovery on retropulsion (pull) test
Stage 3.0 Mild to moderate bilateral involvement, some postural instability but physically independent
Stage 4.0 Severe disability, still able to walk and to stand unassisted
Stage 5.0 Wheelchair bound or bedridden unless aided.
22. Randomisation Person is randomised
immediate PT & OT or
No treatment (unless it becomes necessary)
23. PD REHAB Trial Interventions Details of OT and PT administered will be recorded in detail by the therapists using data acquisition forms piloted in PD OT trial
24. PD REHAB Trial Control arm Control patients consent to have OT and PT deferred until the end of their 15 months in the trial
Investigators vigilant over 15 months for control patients who need therapy (‘safety net’)
At the end of trial patients in control arm referred for therapy by their usual specialist through local NHS referral pathways
25. PD REHAB Trial Assessments
26. PD REHAB Trial Adverse events and reactions Targeted treatment-related adverse events and serious adverse events
“Falls or equipment failure leading to injury requiring a hospital or GP visit”
Initially reported by patients on the resource usage form On receipt of information on AE, request will be sent from BCTU for an adverse event / serious adverse event to be completed by the relevant investigator
Forms can be downloaded from the PD REHAB website
27. Updates to protocol Currently the forms are being piloted – there will be a substantial amendment put in to NRES in the new year, with any amendments.
If there is anything you feel needs changing, please let us know. Eg invitation letter to patients
28. Any questions?
29. PD REHAB Trial Timetable
30. PD REHAB - Randomisation Once a site has received local R&D approval, randomisers will be able to set up passwords for the PD REHAB randomisation programme.
Randomisers must be listed on the delegation log in the site file & it is the responsibility of the PI to ensure they are competent to perform task.
The randomisation programme can be set to “test” mode to allow the randomiser to familiarise themselves with it before randomising participants.
32. Intervention successfully delivered
5 hours ‘dose’ of therapy was similar to that described in other trials
Loss to follow up was small
Strong correlation between outcome measures PD OT Pilot Results