Efficiency of Physiotherapeutic Care in Parkinson's Disease

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00330694
Recruitment Status : Completed
First Posted : May 29, 2006
Last Update Posted : September 3, 2008
ZonMw: The Netherlands Organisation for Health Research and Development
Information provided by:
Radboud University

Brief Summary:

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'.

Condition or disease Intervention/treatment Phase
Parkinson's Disease Other: ParkNet Other: Usual Care Phase 3

Detailed Description:

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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 708 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Efficiency of Physiotherapeutic Care in Parkinson's Disease
Study Start Date : May 2006
Actual Primary Completion Date : July 2007
Actual Study Completion Date : July 2007

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Experimental: I
Implementation of ParkNet within 8 regions
Other: ParkNet
Development of a network of dedicated physiotherapist with specific expertise in Parkinson's Disease and structured referrals to these ParkNet therapists by neurologists.
Other Name: n.a.
Usual Care in 8 regions
Other: Usual Care
No altered organisation of physiotherapy care in Parkinson's Disease

Primary Outcome Measures :
  1. Modified MACTAR scale [ Time Frame: 6 months ]

Secondary Outcome Measures :
  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 ]

Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00330694

Jeroen Bosch Hospital
's Hertogenbosch, Netherlands
Medisch Centrum Alkmaar
Alkmaar, Netherlands
Gelre Ziekenhuis
Apeldoorn, Netherlands
Ziekenhuis Gooi Noord
Blaricum, Netherlands
Reinier de Graaf Groep
Delft, Netherlands
Medisch Centrum Haaglanden, Westeinde
Den Haag, Netherlands
Slingeland Ziekenhuis
Doetinchem, Netherlands
Ziekenhuis Gelderse Vallei
Ede, Netherlands
Catharina Ziekenhuis
Eindhoven, Netherlands
Maxima Medisch Centrum
Eindhoven, Netherlands
Groene Hart Ziekenhuis
Gouda, Netherlands
Kennemer Gasthuis
Haarlem, Netherlands
Ziekenhuis Hilversum
Hilversum, Netherlands
Westfries Gasthuis
Hoorn, Netherlands
Ziekenhuis Bernhoven
Oss, Netherlands
Viecurie Medisch Centrum
Venlo, Netherlands
't Lange land ziekenhuis
Zoetermeer, Netherlands
Gelre Ziekenhuizen
Zutphen, Netherlands
Sponsors and Collaborators
Radboud University
ZonMw: The Netherlands Organisation for Health Research and Development
Principal Investigator: Marten Munneke, PhD UMC st Radboud
Principal Investigator: Bastiaan R Bloem, MD, PhD UMC st Radboud

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Dr M Munneke, UMC St Radboud, Neurology Identifier: NCT00330694     History of Changes
Other Study ID Numbers: 945-04-357
First Posted: May 29, 2006    Key Record Dates
Last Update Posted: September 3, 2008
Last Verified: September 2008

Keywords provided by Radboud University:
Physical Therapy
Organisation of care

Additional relevant MeSH terms:
Parkinson Disease
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Movement Disorders
Neurodegenerative Diseases