Who will be entered into the trial?
Patients will be eligible for randomisation into the trial if they have a confirmed diagnosis of idiopathic PD as defined by the UK PDS Brain Bank Criteria, and report limitations in ADL. Patients will be excluded if they have dementia (as defined by the patient’s clinician), or have received occupational therapy or physiotherapy in the past 12 months for a PD-related problem.
Following randomisation into the trial, and referral to the physiotherapy and occupational therapy departments, how long can elapse before the therapist starts to deliver the therapy intervention?
The initial physiotherapy and occupational therapy assessments should occur within 4 weeks of patient randomisation. The therapy interventions should ideally be completed within 3 months post-randomisation.
Does each patient randomised into the treatment arm need to receive an assessment from both an occupational therapist and a physiotherapist?
Yes. All patients randomised into the treatment arm should receive an assessment from an occupational therapist and a physiotherapist.
Can a joint initial occupational therapy and physiotherapy
assessment be carried out for patients randomised into the
Yes, it is perfectly acceptable for one joint assessment between the two disciplines to be carried out.
Does the patient have to receive both occupational therapy
No. Each patient must receive an initial occupational therapy and physiotherapy assessment. Whether a patient requires both therapies, or just occupational therapy or physiotherapy, will be dependent on the findings of the initial assessments.
Does occupational therapy and physiotherapy have to be delivered concurrently, or can one therapy follow the other?
It is acceptable for the therapies to be delivered concurrently or one after the other as long as the initial assessments have been carried out within 4 weeks of patient randomisation, and both the occupational therapy and physiotherapy interventions can be completed within the 3-month intervention period.
In what setting should the therapy be delivered?
The therapy can be delivered in any setting other than inpatient i.e. the patients must be living in their own homes at the time of intervention. The intervention will most likely be delivered in whatever setting you would normally provide therapy in your particular services. However, the setting of therapy may also be dependent on the individual goals of the patient and the equipment and resources required to deliver the treatment needed.
The PD REHAB trial is investigating the provision of occupational therapy and physiotherapy for people with Parkinson’s disease who report limitations in activities of daily living. Does this mean that the intervention provided by therapists is limited to rehabilitation of activities of daily living?
The primary purpose of the study is to address activity of daily living limitations for three reasons:
- Activity restriction was identified as important by people with PD and their carers;
- We are using change in activity of daily living restriction as our main outcome measure;
- We know from other populations (such as stroke) that this intervention is effective in improving quality of life and reducing carer burden.
However, it is recognised that each patient will present with very individual needs and goals, and that therapists have professional autonomy. We just ask that activity restriction be addressed first.
A framework for the content of the therapy to be delivered within the trial has been provided. As therapists, do we need to limit our practice to providing assessment and treatment techniques that feature within this framework only?
No. The framework has been devised through analysis of the current evidence base and the use of expert consensus and is there to provide a “menu” of activities and interventions that may be beneficial for the patients in the trial. It has been designed to provide general guidance to therapists as we recognise that practitioners will have a spectrum of experience in treating PD. Some therapists may have limited experience with this patient group and so may welcome additional support. The framework is not meant to be prescriptive or to decrease therapist autonomy in any way. The interventions delivered should still reflect what a therapist perceives to be the best possible treatment for a patient’s individualised needs.
A dose of 5-6 visits delivered by both the occupational therapist and physiotherapist over a period of 2 months is recommended. Does the therapy delivered have to match up to this recommended dose?
No. The recommended dose provided in the trial literature reflects the average dose delivered in the pilot study for PD REHAB and that reported in survey literature for occupational therapy and physiotherapy practice in current services. Again, it is not meant to be prescriptive and the dose of therapy delivered should reflect a patient’s individual needs. We recognise that some patients will require more than 6 visits whilst others may require less. The only constraint is that the therapy should be completed before the patient’s assessment at 3 months post-randomisation.
When delivering the intervention, can I monitor the patient’s progress through outcome measures?
Yes. The patient will be assessed for the purposes of the trial at a number of assessment points (randomisation, 3 months, 9 months and 15 months) through posted, self-completed outcome measures. However, it is acceptable to utilise outcome measures throughout the delivery of therapy sessions to inform the progression and dose of your treatment.
How should I record the therapy assessment and interventions delivered for patients in the trial?
All findings of assessments and interventions delivered for patients during the trial should be recorded as in your normal practice in the patient’s individual notes. In addition we will ask you to summarise the intervention delivered for each patient in an intervention log for each session. The intervention logs will be available to download from the PD REHAB website.