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Parkinson's DiseasePhase 3NCT00330694

Efficiency of Physiotherapeutic Care in Parkinson's Disease

A Phase 3 study testing ParkNet in people with Parkinson's Disease, run by Radboud University Medical Center at 18 sites in Netherlands.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 20 to 80 years
Conditions the study is for
Parkinson's Disease
What is being tested?
ParkNet
Could I receive a placebo?
No, everyone receives an active treatment
How many people
708 participants
Where
18 sitesNetherlands
Study dates
May 2006to Jul 2007
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 20 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.

Trial locations and contacts

18 sites in 1 country.

18 sites in 1 country

Netherlands18 sites

  • Jeroen Bosch Hospital

    's-Hertogenbosch

  • Medisch Centrum Alkmaar

    Alkmaar

  • Gelre Ziekenhuis

    Apeldoorn

  • Ziekenhuis Gooi Noord

    Blaricum

  • Reinier de Graaf Groep

    Delft

  • Slingeland Ziekenhuis

    Doetinchem

  • Ziekenhuis Gelderse Vallei

    Ede

  • Catharina Ziekenhuis

    Eindhoven

  • Maxima Medisch Centrum

    Eindhoven

  • Groene Hart Ziekenhuis

    Gouda

  • Kennemer Gasthuis

    Haarlem

  • Ziekenhuis Hilversum

    Hilversum

  • Westfries Gasthuis

    Hoorn

  • Ziekenhuis Bernhoven

    Oss

  • Medisch Centrum Haaglanden, Westeinde

    The Hague

  • Viecurie Medisch Centrum

    Venlo

  • 't Lange land ziekenhuis

    Zoetermeer

  • Gelre Ziekenhuizen

    Zutphen

Other trials in Netherlands

About this study

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'.

Read the 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.

Being tested
ParkNet, Usual Care
Keywords
Physical Therapy, Organisation of care
Medical subject headings
Parkinson Disease

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • ParkNetOther

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

  • Usual CareOther

    No altered organisation of physiotherapy care in Parkinson's Disease

Study groups in NCT00330694
Study groupRoleWhat they receive
IExperimentalImplementation of ParkNet within 8 regions
Receives: Other: ParkNet
IIOtherUsual Care in 8 regions
Receives: Other: Usual Care

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Modified MACTAR scale

    Measured: 6 months

Secondary outcomes (22)

  1. Parkinson Activity Scale (secondary)

    Measured: 6 months

  2. Costs

    Measured: 6 months

  3. Proportion of correct referrals (tertiary)

    Measured: 6 months

  4. Quality of physiotherapy(tertiary)

    Measured: 6 months

  5. Incidence of Falls (tertiary)

    Measured: 6 months

  6. ALDS (tertiary)

    Measured: 6 months

  7. SF-36 (tertiary)

    Measured: 6 months

  8. EQ-5D (tertiary)

    Measured: 6 months

  9. Satisfaction of patients and professionals (tertiary)

    Measured: 6 months

  10. Self Assessment Disability Scale (tertiary)

    Measured: 6 months

  11. Freezing of Gait Questionnaire {tertiary}

    Measured: 6 months

  12. 6 meter walk test {tertiary}

    Measured: 6 months

  13. 4x3 meter walk test (tertiary)

    Measured: 6 months

  14. Single leg stance (tertiary)

    Measured: 6 months

  15. Posture and Gait score (tertiary)

    Measured: 6 months

  16. Timed Up and Go (tertiary)

    Measured: 6 months

  17. Falls Efficacy Scale {tertiary}

    Measured: 6 months

  18. 9-hole pegboard test {tertiary}

    Measured: 6 months

  19. Health Anxiety and Depression Scale (tertiary)

    Measured: 6 months

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

    Measured: 6 months

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

    Measured: 6 months

  22. PDQ-39 (Mobility Scale)

    Measured: 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted29 May 2006 (estimated)
  2. Study startMay 2006
  3. Primary completionJul 2007
  4. Study completionJul 2007

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Care provider, Outcomes assessor
Enrolment
708 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00330694
Sponsor's protocol ID
945-04-357
Status last verified
Sep 2008
First submitted
24 May 2006
Last updated
3 Sep 2008
Results posted
No
Data monitoring committee
No

Publications

  • 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.

    PubMed 19959398

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing ParkNet in people with Parkinson's Disease, run by Radboud University Medical Center at 18 sites in Netherlands.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 3 Sep 2008. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 18 sites in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Modified MACTAR scale (time frame: 6 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00330694, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Sep 2008.

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