Efficiency of Physiotherapeutic Care in Parkinson's Disease
1 other identifier
interventional
708
1 country
18
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'.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started May 2006
Shorter than P25 for phase_3
18 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2006
CompletedFirst Submitted
Initial submission to the registry
May 24, 2006
CompletedFirst Posted
Study publicly available on registry
May 29, 2006
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2007
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2007
CompletedSeptember 3, 2008
September 1, 2008
1.2 years
May 24, 2006
September 1, 2008
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Modified MACTAR scale
6 months
Secondary Outcomes (22)
Parkinson Activity Scale (secondary)
6 months
Costs
6 months
Proportion of correct referrals (tertiary)
6 months
Quality of physiotherapy(tertiary)
6 months
Incidence of Falls (tertiary)
6 months
- +17 more secondary outcomes
Study Arms (2)
I
EXPERIMENTALImplementation of ParkNet within 8 regions
II
OTHERUsual Care in 8 regions
Interventions
Development of a network of dedicated physiotherapist with specific expertise in Parkinson's Disease and structured referrals to these ParkNet therapists by neurologists.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (18)
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
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
Medisch Centrum Haaglanden, Westeinde
The Hague, Netherlands
Viecurie Medisch Centrum
Venlo, Netherlands
't Lange land ziekenhuis
Zoetermeer, Netherlands
Gelre Ziekenhuizen
Zutphen, Netherlands
Related Publications (1)
Munneke M, Nijkrake MJ, Keus SH, Kwakkel G, Berendse HW, Roos RA, Borm GF, Adang EM, Overeem S, Bloem BR; ParkinsonNet Trial Study Group. Efficacy of community-based physiotherapy networks for patients with Parkinson's disease: a cluster-randomised trial. Lancet Neurol. 2010 Jan;9(1):46-54. doi: 10.1016/S1474-4422(09)70327-8. Epub 2009 Dec 1.
PMID: 19959398DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Marten Munneke, PhD
UMC st Radboud
- PRINCIPAL INVESTIGATOR
Bastiaan R Bloem, MD, PhD
UMC st Radboud
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
May 24, 2006
First Posted
May 29, 2006
Study Start
May 1, 2006
Primary Completion
July 1, 2007
Study Completion
July 1, 2007
Last Updated
September 3, 2008
Record last verified: 2008-09