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A randomised controlled trial to assess the clinical- and cost-effectiveness of PT and OT in PD Cally Rick

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.

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A randomised controlled trial to assess the clinical- and cost-effectiveness of PT and OT in PD Cally Rick

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    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 40 sites 750 participants will be randomised 36 months

    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 patients 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 Patients GP will be informed in writing of the patients participation in the trial with the patients 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 Euroqol

    9. Information needed to randomise Log on & password Patient details NEADL score 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.

    21. Recruitment

    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

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