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NCT Number: NCT00330694

Efficiency of Physiotherapeutic Care in Parkinson's Disease

In the course of their disease, most patients with Parkinson's Disease (PD) face mounting mobility deficits, including difficulties with walking, balance, posture and transfers. This frequently leads to (fear of) falls, injuries, loss of independence, and inactivity which causes social isolation and increases the risk of osteoporosis or cardiovascular disease. These mobility deficits are difficult to treat with drugs and neurosurgery. However, physiotherapy is deemed effective in improving mobility deficits in PD. Physiotherapy is widely prescribed for this purpose in the Netherlands. Yet, the efficiency of current "usual care" physiotherapy can be questioned, for two reasons. First, the referral process seems inadequate because patients are mainly referred by neurologists who often lack insight into the (im-)possibilities of physiotherapy for PD. Consequently, patients with a real need for physiotherapy are not always referred (undertreatment), whereas others without a real need are (overtreatment). Furthermore, most therapists treating PD patients are not specifically trained in treating these patients. This is not surprising because average therapists rarely treat more than two patients per year in their practice. Therefore, patients who are being referred probably receive suboptimal treatment.

The objective of this study is to evaluate whether the efficiency of physiotherapeutic care for patients with Parkinson's disease can be improved, at a reduced cost, by targeting two key elements of the current care system: a) inadequate referral by neurologists; b) suboptimal treatment by physiotherapists. We expect that optimal referral combined with expert treatment will increase the efficiency, as reflected by increased health benefits for patients at equal or reduced costs'.

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Key information

Conditions

Parkinson's Disease Basal Ganglia Diseases Brain Diseases Central Nervous System Diseases Movement Disorders Nervous System Diseases Neurodegenerative Diseases Parkinson Disease Parkinsonian Disorders Synucleinopathies

Age range

20 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Jeroen Bosch Hospital, 's-Hertogenbosch, Netherlands

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About this study

Design In a Cluster Randomised Trial, 16 clusters will be randomly allocated to either network care (8 clusters with an altered organisation of physiotherapeutic care) or usual care (8 clusters with unchanged organisation of physiotherapeutic care). Clusters are formed by all PD patients living in the communities connected to participating regional hospitals in the 16 clusters.

The health care intervention in the experimental group has two elements: (a) an improved quality of referrals by neurologists; and (b) an improved quality of interventions by physiotherapists. Brief description Network Care: In each of the Network Care clusters, 5 to 7 motivated therapists are selected to enroll in a regional ParkNet and consequently trained. Training is focused at correct use of the evidence-based guidelines for physiotherapy in PD (Keus et al, 2006). This training consists of a 5-day competence-oriented course, web-based continues education supported by seminars, and use of a PD specific electronic patient record. Neurologists are informed about indications for referral to physiotherapy. Improved communication between neurologist and ParkNet therapists is initiated and supported.

Following implementation of the health care change, PD patients attending the neurological outpatient clinics of the individual hospitals within the clusters will be asked to participate. During a period of 6 months, PD patients will enrol in the study. Enrollees will be followed for 6 months to measure the use and quality of physiotherapy, patient health benefit and satisfaction, and costs.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients with idiopathic PD, diagnosed according to the Brain Bank criteria of the UK Parkinson's Disease Society
  • Living independently in the community
  • Able to complete the trial questionnaires.

Exclusion criteria

  • Atypical parkinsonian syndromes
  • Hoehn & Yahr stage 5
  • Severe cognitive impairment
  • Presence of major psychiatric disorders
  • Severe co-morbidity (e.g. cancer) that interferes with daily functioning.

Treatment and study plan

ParkNet

Other

Development of a network of dedicated physiotherapist with specific expertise in Parkinson's Disease and structured referrals to these ParkNet therapists by neurologists.

Usual Care

Other

No altered organisation of physiotherapy care in Parkinson's Disease

Primary outcomes

  1. Modified MACTAR scale

    Time frame: 6 months

Secondary outcomes

  1. Parkinson Activity Scale (secondary)

    Time frame: 6 months

  2. Costs

    Time frame: 6 months

  3. Proportion of correct referrals (tertiary)

    Time frame: 6 months

  4. Quality of physiotherapy(tertiary)

    Time frame: 6 months

  5. Incidence of Falls (tertiary)

    Time frame: 6 months

  6. ALDS (tertiary)

    Time frame: 6 months

  7. SF-36 (tertiary)

    Time frame: 6 months

  8. EQ-5D (tertiary)

    Time frame: 6 months

  9. Satisfaction of patients and professionals (tertiary)

    Time frame: 6 months

  10. Self Assessment Disability Scale (tertiary)

    Time frame: 6 months

  11. Freezing of Gait Questionnaire {tertiary}

    Time frame: 6 months

  12. 6 meter walk test {tertiary}

    Time frame: 6 months

  13. 4x3 meter walk test (tertiary)

    Time frame: 6 months

  14. Single leg stance (tertiary)

    Time frame: 6 months

  15. Posture and Gait score (tertiary)

    Time frame: 6 months

  16. Timed Up and Go (tertiary)

    Time frame: 6 months

  17. Falls Efficacy Scale {tertiary}

    Time frame: 6 months

  18. 9-hole pegboard test {tertiary}

    Time frame: 6 months

  19. Health Anxiety and Depression Scale (tertiary)

    Time frame: 6 months

  20. Physical activities assessed with the LAPAQ questionnaire (tertiary)

    Time frame: 6 months

  21. Caregiver burden assessed with the Care Giver Strain Index (tertiary)

    Time frame: 6 months

  22. PDQ-39 (Mobility Scale)

    Time frame: 6 months

Sponsors and collaborators

Lead sponsor

Radboud University Medical Center

Other

Collaborators

  • ZonMw: The Netherlands Organisation for Health Research and Development

Registry information

Important dates

Study start
2006
Primary completion
2007
Study completion
2007
First posted
May 29, 2006
Registry last updated
Sep 3, 2008

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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