Occupational Therapy to Optimise

Independence in Parkinson’s Disease:

the Designing and Recording of a

Randomised Controlled Trial

Intervention

Charmaine Meek, Eric Morgan, Marion Walker, Alexandra Furmston, Ana Aragon, Angela Birleson, Vicky Kelly, Carl Clarke

and Catherine Sackley

Background

Occupational therapy and Parkinson’s

disease

Clinical management of Parkinson’s disease (PD) predominantly consists of

pharmacological therapy, but even with optimal medical treatment in place

disability can persist and progress.

In particular, PD has a profound impact on activities of daily living (ADL),

resulting in increased dependence.

For this reason, occupational therapy (OT) is often employed as an adjunct to

medical management.

However, supportive evidence of occupational therapy in PD is limited with a

systematic review noting insufficient evidence to support or refute the

efficacy of OT for PD (Deane et al, 2001).

In 2005 a pilot randomised controlled trial (RCT) began to add to the

evidence base – the PDOT trial (Clarke et al, 2009).

Overview of the PDOT trial

Objective: To perform a pilot trial of OT for the optimisation of functional independence in PD to assess feasibility, acceptability, accrual/withdrawal rates, outcome measures, and to inform a sample-size calculation for a phase III RCT

Design: A phase II pragmatic RCT with blinded assessment

Participants: people with idiopathic PD. exhibiting difficulties with ADL, who had not received OT in the past 12 months

Setting: Participants recruited from clinics in the West Midlands and treated in their home environment

Intervention: Participants randomised to receive either individualised OT or no intervention

Outcome measurement: Nottingham Extended Activities of Daily Living Scale, Rivermead Mobility Index, Unified Parkinson’s Disease Rating Scale, Parkinson’s Disease Questionnaire-39 and EuroQol-5D recorded at baseline, 2 months and 8 months

Clarke et al (2009)

Reporting of an intervention

To ensure reproducibility, the reporting of an RCT should include “precise

details of the interventions intended for each group, and how and when they

were actually administered” (CONSORT Statement, Item 4; Moher et al,

2001).

This requirement can be fulfilled through publication of a designated

intervention paper (Deane et al, 2006).

Therefore, a paper was published to outline the PDOT intervention (Meek

et al, 2010) :

Describing the process undertaken to design the therapeutic

intervention

Presenting the intervention log used in the trial

Reporting the information captured by the intervention log

Discussing the limitations of the log and the measures taken to improve

the tool for the next trial.

Methods

Development of the intervention

A three stepped approach was utilised:

1. Published trial evidence was gathered (until recruitment commenced in

July 2005) to support evidence-based practice including; OT specific

PD studies, multidisciplinary trials incorporating OT, wider PD

rehabilitation literature and clinical guidelines

2. Current UK practice was examined through two published surveys

3. An expert steering group evaluated and synthesised the findings of the

first two steps with expert consensus, formalising the PDOT

intervention.

Aim: To provide an intervention that was informed by best practice, but

could be delivered within the structure and format of the NHS; an

“enhanced” current practice intervention.

Step 1: OT specific PD evidence

Systematic reviews uncovered:

Three RCTs- Gibberd et al (1981; n=24), Gauthier et al (1987; n=64),

Fiorani et al (1997; n=20)

One observational study- Beattie and Caird (1980)

Some studies have produced positive outcomes, reporting improvements in

psychological well-being, bradykinesia, akathesia, (Gautheir et al, 1987),

walking velocity, ADL and quality of life (Fiorani et al, 1997) following OT.

In comparison, Gibberd et al (1981) reported no significant changes in any

outcomes following their intervention.

The interventions within these trials were heterogeneous in nature and limited

in their reporting, providing little with which to inform the PDOT

intervention

The trials were also all of a low methodological quality.

Step 1: Other PD evidence Multidisciplinary trials including OT

These observational studies (Trend et al, 2002; Ellis et al, 2005)and RCTs (Wade et al, 2003) have produced both positive and inconclusive findings.

It is difficult to pinpoint the effect of the OT within these interventions, and the reporting of treatment is limited.

Wider PD literature

There is positive evidence for the use of external cueing techniques during functional tasks, such as sit to stand (Mak et al, 2004), reaching (Ma et al, 2004), writing (Oliveira et al, 1997) and walking (Thaut et al, 1996; Rochester et al, 2005).

Supportive evidence also exists for the use of cognitive movement strategies (Kamsma et al, 1995).

This evidence was useful for informing the PDOT intervention but, at the time of the trial, was still low in methodological quality.

Clinical guidelines

Lack of clinical guidelines at the time of commencement of the trial.

Guidelines supported the inclusion of OT in PD management, but did not detail how or what should be delivered.

Step 2: Current OT practice

Two surveys have been published, detailing current (Deane et al, 2003a) and perceived best practice (Deane et al, 2003b) for OT for PD in the UK.

The surveys were used extensively to provide a framework for the PDOT intervention, due to the limited trial evidence available.

The current practice survey provided an insight into:

Dose of an average course of OT: six sessions lasting 45 minutes delivered over two months

Focus of OT treatment: improvement and maintenance of transfers and mobility, ADL and home safety

Content of OT treatment: individualised to suit the patient’s needs

The best practice survey provided an insight into:

Potentially effective treatment techniques: cueing, cognitive movement strategies, education, provision of equipment/ environmental adaptation, techniques for management of medication on/ off fluctuations, fatigue and anxiety, and involvement of the carer (teaching handling techniques)

Step 3: Formalising the intervention through

expert group consensus

The expert group consisted of: clinical occupational therapists, researchers,

clinical managers, educators and members of the PDOT study team.

The group considered the following when formalising the intervention:

Who the treating clinician should be

The structure of the intervention process

The focus, content and dose of the intervention

How the intervention should be documented.

Treating clinician: a registered OT with experience in treating people with PD

Structure of the intervention process: treatment delivered within the standard

OT process as defined by the College of Occupational Therapists in the UK

(Creek, 2003)

Step 3: Formalising the intervention through

expert group consensus

Referral Structure of the process

(continued): Information gathering

Initial assessment

Reason for intervention/ needs

identification/ problem information

Identification of aims/ goal setting

Action planning

Action (treatment implementation)

Ongoing assessment/ revision of action

Outcome and outcome measurement

End of intervention/ discharge

Review

Adapted from Creek (2003)

Focus of the PDOT intervention

To address mobility and transfers, ADL and home safety to reflect the findings of the current practice survey

In addition, client centredness and practitioner autonomy would be maintained by addressing additional problems and patient goals as appropriate for the individual patient

Content of the PDOT intervention

To reflect the treatments deemed effective in the best practice survey and from the evidence base e.g. equipment provision/ environmental adaptation, task specific training utilising external cueing and cognitive movement strategies, education

Individualised, based on the therapist’s judgement and patient’s needs

Dose of the PDOT intervention

To loosely reflect the dose of OT uncovered in the current practice survey: six sessions lasting 45 minutes delivered over two months, but still individualised to meet patient’s needs

Step 3: Formalising the intervention through

expert group consensus

Step 3: Formalising the intervention through

expert group consensus

Documenting the therapeutic process: the intervention log

No specific PD coding system was available, so an intervention log was

adopted from a previous trial (Sackley et al, 2004).

Results

Results Intervention group characteristics:

39 people with PD recruited: 19 randomised to receive the intervention

11 male and eight female

Mean age of 74.8 years

Mean Barthel score of 18 out of 20

12 patients with a Hoehn and Yahr score of 2.0-2.5, six with a score of 3.0 and one patient with a score of 4.0

All 19 patients completed both their initial assessments and the treatment sessions required to address the goals set

Frequency, duration and dose of the intervention:

Treatment was delivered by one OT

Mean number of visits was 5.7 (range 3-9, SD 1.2)

108 visits were carried out in total

The interval between visits varied from three days to 63 days

Initial assessment took a median of 60 minutes (range 45-90 minutes)

Follow up sessions lasted a median of 50 minutes (range 5-180 minutes)

Mean of 5.4 hours spent with each patient in total

Results: Distribution of therapist visits

0

1

2

3

4

5

6

7

8

9

1 2 3 4 5 6 7 8 9

Number of visits

Nu

mb

er

of

pati

en

ts

Results: Content of the intervention

The content of the

intervention for each

patient was categorised

and recorded as time

(mins) spent under the

appropriate headings by

the therapist.

More than one category

of intervention would

have often been delivered

during a single therapy

session.

Two hundred and

seventy four

interventions were

delivered in total.

Intervention Category Number of interventions

delivered (n=274)

Goal setting 15

Adaptive equipment 56

Environmental adaptations 38

Transfers/ mobility training 46

ADL training 35

Techniques/ education 25

Wheelchairs/ seating 0

Provision of information 8

Caregiver training 4

Liaison 1

Referral 14

Other 0

Review/ discussion 32

Results: Intervention log

Positive

Easy to use

Contains categories relevant to

the treatment being delivered

Negative

Overlap between categories

Difficulties identifying the

primary aim of an intervention for

accurate categorisation

The occupational therapist gave the following feedback for the intervention

log on completion of the trial:

Discussion

Discussion: Dose and content of the

PDOT intervention Dose:

Treatment delivered had a comparable does to the findings of the current

practice survey by Deane et al (2003a).

Content:

The largest number of therapy interventions involved some form of

adaptive equipment provision or environmental adaptation. This has

been found to lead to significant improvements in ADL in the stroke

population (Logan et al, 1997).

Many therapist visits involved transfers, mobility and ADL training,

mirroring the OT goals set out in the current practice survey by Deane et

al (2003a).

Review and discussion featured highly, highlighting the importance of

communication in OT.

The provision of education and teaching of techniques was particularly

important to the sample population due to their high functioning nature.

Discussion: Appraisal of the intervention

log

The intervention log captured the broad focus of treatment and

the dose delivered, but did not provide precise details on every

individual treatment session for each participant

Whilst it would be difficult, and potentially of limited use, to

record this information, it is suggested that the function and

process of a complex intervention should be standardised to

then allow it to be adapted to “local conditions” (Hawe et al,

2004).

Within the context of occupational therapy for people with PD,

this means identifying the areas of limitation targeted during

therapy, and the types of treatment used to address them.

Therefore, the intervention log required further development if it

was to be used within future trials.

The next step… PD REHAB A phase III, multi-centre RCT to assess the clinical and cost effectiveness of

physiotherapy and OT is currently being conducted- PD REHAB.

The intervention log:

As in PDOT, details of the therapy delivered need to be captured.

The intervention log has been revised to record more specific information, whilst still retaining the flexibility needed to accommodate individual variation.

The intervention log now takes on a grid format to allow cross referencing of the potential areas of impairment uncovered when goal setting, and the type of intervention that could be utilised.

This revised log is currently being piloted within the PD REHAB trial.

The intervention:

No further OT specific trials have been published within the PD lit.

However, higher methodological quality trials have been published in the wider PD rehabilitation literature (e.g. Nieuwboer et al, 2007), and national/ international guidelines for the management of PD (NICE, 2006;Stuerkenboom et al, 2008).

As the evidence base has moved forward, the intervention delivered in PD REHAB may differ slightly from that in PDOT, but the focus is the same.

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