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Parkinson's DiseaseOTiPNCT01336127

Effectiveness Study of Occupational Therapy in Parkinson's Disease

A study testing Occupational Therapy in people with Parkinson's Disease, run by Radboud University Medical Center at 10 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

The purpose of this study is to determine the effectiveness of occupational therapy in Parkinson's disease. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Parkinson's Disease
What is being tested?
Occupational Therapy
Could I receive a placebo?
No, everyone receives an active treatment
How many people
191 participants
Where
10 sitesNetherlands
Study dates
Apr 2011to Jun 2013
Phase
Interventional
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 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Idiopathic Parkinson's Disease
  • Indication for referral to occupational therapy
  • Home dwelling
  • Available for informal support minimal two times a week to a patient who participates in the study
  • Available to take part in the intervention

Who cannot join

  • Not capable of completing the self assessment forms (i.e. due to language problems or severe cognitive problems_MMSE score < 24).
  • Co morbidity with symptoms that interfere with actively taking part in the intervention (e.g psychosis, severe heart condition). Or limitations in activities are dominated by the co morbid condition rather than by Parkinson's Disease.
  • Current participation in other allied health research (i.e. PARKFIT)
  • Having received occupational therapy intervention in the last 3 months

Trial locations and contacts

10 sites in 1 country.

10 sites in 1 country

Netherlands10 sites

  • Meander Medisch Centrum

    Amersfoort

  • Gelre Ziekenhuizen

    Apeldoorn

  • Tergooiziekenhuizen

    Blaricum

  • Deventer Ziekenhuis

    Deventer

  • St Jansdal

    Harderwijk

  • Tergooiziekenhuizen

    Hilversum

  • St. Antonius

    Utrecht

  • Diakonessenhuis

    Zeist

  • Gelre Ziekenhuizen

    Zutphen

  • Isala Klinieken

    Zwolle

Other trials in Netherlands

About this study

Official title: Effectiveness of Occupational Therapy in Parkinson's Disease: a Randomized Controlled Trial

The purpose of this study is to determine the effectiveness of occupational therapy in Parkinson's disease.

Read the detailed description

Parkinson's disease is a complex disabling condition progressively affecting activities and participation of patients. Occupational Therapy aims to optimise functional performance and engagement in meaningful roles and activities. The lack of scientific evidence for the effectiveness of Occupational Therapy (OT) in Parkinson's Disease (PD) highlights the urgent need for high quality intervention studies. The Dutch clinical practice guideline for OT in PD (2008)offers a good basis for conducting an intervention study. The completed OTiP pilot underscored the feasibility and the need for a large scale trial.

The OTiP study evaluates the effectiveness of OT in improving daily functioning of patients with PD.

Being tested
Occupational Therapy
Keywords
Occupational Therapy, Parkinson's Disease, Effectiveness, RCT, Activities of daily living, Participation, Caregiver's Burden, Economic evaluation
Medical subject headings
Parkinson Disease

What participants receive

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

  • Occupational TherapyBehavioural

    Patients in the experimental group will receive 10 weeks (maximum 16 hours) occupational therapy according to a treatment protocol, which is based on the Dutch evidence based guideline for occupational therapy in Parkinson's Disease and refined for this study.

Study groups in NCT01336127
Study groupRoleWhat they receive
occupational therapyExperimental10 weeks occupational therapy according to a protocol (OTiP protocol) based on the Dutch guidelines of occupational therapy in Parkinson's disease
Receives: Behavioral: Occupational Therapy
No occupational therapyNo interventionPatients and their caregivers in the control group will have no occupational therapy intervention until their last measurement has taken place (6 months).

What is being measured

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

  1. Canadian Occupational Performance Measure (COPM)

    Perceived activity performance. Three months will be the primary analysis. Effects at follow up will be measured at 6 months (see secondary outcome measures)

    Measured: 3 months

Secondary outcomes (24)

  1. Perceive Recall Plan Perform Measure (PRPP)

    Observational measure. Activity performance patient

    Measured: 3 months

  2. Zarit Burden Inventory (ZBI)

    Perceived caregiver burden.(caregiver)

    Measured: 3 months

  3. Parkinson's Disease Questionnaire 39 (PDQ-39)

    Health related Quality of life (Parkinson specific; patient)

    Measured: 3 months

  4. Resource utilization questionnaire

    For evaluating costs. (patient and caregiver)

    Measured: 3 months

  5. Objective Caregiving Burden

    Evaluating hours of care (costs). (caregiver)

    Measured: 3 months

  6. Activity Card Sort (ACS)

    Participation measure:% retained activities.(patient)

    Measured: 3 months

  7. The Utrecht Scale for evaluation of Rehabilitation Participation (USER-P)(section III)

    Satisfaction with participation (patient)

    Measured: 3 months

  8. Becks depression Inventory (BDI)

    Mood and Depression. (patient)

    Measured: 3 months

  9. Hospital Anxiety and Depression Scale (HADS)

    Mood and depression. (caregiver).

    Measured: 3 months

  10. The Utrecht Proactive Coping Competence list (UPCC)

    Proactive coping skills. (patient and caregiver)

    Measured: 3 months

  11. Fatigue Severity Scale (FSS)

    Impact of fatigue (patient)

    Measured: 3 months

  12. Canadian Occupational Performance Measure (COPM-satisfaction)

    Perceived satisfaction with performance. (patient)

    Measured: 3 months

  13. Quality of life-overall

    One question on rating overall quality of life (VAS scale). (patient and caregiver).

    Measured: 3 months

  14. Zarit Burden Inventory (ZBI)

    Perceived caregiver burden. (caregiver)

    Measured: 6 months

  15. Parkinson's Disease Questionnaire 39 (PDQ-39)

    Health related Quality of life (Parkinson specific)

    Measured: 6 months

  16. Objective Caregiving Burden

    Evaluating hours of care (costs). (caregiver).

    Measured: 6 months

  17. Euroqol EQ-5D

    Quality of life. Used for patient and caregiver in evaluation of cost effectiveness

    Measured: 6 months

  18. Canadian Occupational Performance Measure (COPM)

    Perceived performance in activities. Is primary outcome measure at 3 months, but data of 6 months (follow up) wil be used in a secondary analysis and analysis of cost effectiveness.

    Measured: 6 months

  19. Canadian Occupational Performance Measure (COPM-satisfaction)

    Perceived satisfaction with performance. (patient)

    Measured: 6 months

  20. The Utrecht Scale for evaluation of Rehabilitation Participation (USER-P)(section III)

    Satisfaction with participation (patient)

    Measured: 6 months

  21. Becks depression Inventory (BDI)

    Mood and Depression. (patient)

    Measured: 6 months

  22. Hospital Anxiety and Depression Scale (HADS)

    Mood and depression. (caregiver).

    Measured: 6 months

  23. The Utrecht Proactive Coping Competence list (UPCC)

    Proactive coping skills. (patient and caregiver)

    Measured: 6 months

  24. Fatigue Severity Scale (FSS)

    Impact of fatigue (patient)

    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 posted15 Apr 2011 (estimated)
  2. Study startApr 2011
  3. Primary completionFeb 2013
  4. Study completionJun 2013

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 N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
191 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01336127
Sponsor's protocol ID
W.OR09-29
Acronym
OTiP
Status last verified
Aug 2014
First submitted
17 Mar 2011
Last updated
27 Aug 2014
Results posted
No
Data monitoring committee
No

Publications

  • Sturkenboom IH, Hendriks JC, Graff MJ, Adang EM, Munneke M, Nijhuis-van der Sanden MW, Bloem BR. Economic evaluation of occupational therapy in Parkinson's disease: A randomized controlled trial. Mov Disord. 2015 Jul;30(8):1059-67. doi: 10.1002/mds.26217. Epub 2015 Apr 8.

    PubMed 25854809

  • Sturkenboom IH, Graff MJ, Hendriks JC, Veenhuizen Y, Munneke M, Bloem BR, Nijhuis-van der Sanden MW; OTiP study group. Efficacy of occupational therapy for patients with Parkinson's disease: a randomised controlled trial. Lancet Neurol. 2014 Jun;13(6):557-66. doi: 10.1016/S1474-4422(14)70055-9. Epub 2014 Apr 8.

    PubMed 24726066

  • Sturkenboom IH, Graff MJ, Borm GF, Adang EM, Nijhuis-van der Sanden MW, Bloem BR, Munneke M. Effectiveness of occupational therapy in Parkinson's disease: study protocol for a randomized controlled trial. Trials. 2013 Feb 2;14:34. doi: 10.1186/1745-6215-14-34.

    PubMed 23374761

Questions about this trial

What is this clinical trial studying?

A study testing Occupational Therapy in people with Parkinson's Disease, run by Radboud University Medical Center at 10 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 5 inclusion and 4 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 27 Aug 2014. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 10 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.

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?

Canadian Occupational Performance Measure (COPM) (time frame: 3 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 NCT01336127, which also lists 3 linked publications.

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 27 Aug 2014.

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