Parkinson's DiseaseOTiP pilotNCT01010529
Feasibility of a Trial Evaluating the Effectiveness 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 4 sites in Netherlands.
Trial summary
The purpose of this study is to determine the feasibility of a RCT evaluating the effectiveness of occupational therapy in Parkinson's disease. Read more about this study
- Who is it for?
- Any age
- 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
- 43 participants
- Where
- 4 sitesNetherlands
- Study dates
- Oct 2009to Jun 2010
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- idiopathic Parkinson's Disease according to UK Brain Bank Criteria
- home dwelling
- indication for occupational therapy (according to criteria in the evidence based guideline)
- available to provide informal support minimal two times a week to a patient who participates in the study.
Who cannot join
- not capable of completing the self assessment forms (i.e. due to language or severe cognitive problems)
- comorbidity 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 (IMPACT, PARKFIT, ERGODIM)
- having received occupational therapy intervention in the last 12 months
Trial locations and contacts
4 sites in 1 country.
Netherlands4 sites
Meander Medisch Centrum, locatie Elisabeth
Amersfoort, 3816CP
Gelre Ziekenhuizen, locatie Lukas
Apeldoorn, 7300DS
Alysis Zorggroep, Ziekenhuis Rijnstate
Arnhem, 6800TA
Ziekenhuis Rivierenland Tiel
Tiel, 4000HA
About this study
The purpose of this study is to determine the feasibility of a RCT evaluating 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 recently developed Dutch clinical practice guideline for OT in PD offers a good basis for conducting an intervention study. This proposed pilot study is an important step towards setting up a large scale RCT to evaluate the effectiveness of OT in improving daily functioning of patients with PD and reducing caregivers' burden.
- Conditions
- Parkinson's Disease
- Being tested
- occupational therapy
- Keywords
- Occupational Therapy, Parkinson's Disease, Feasibility, Effectiveness, RCT, Activities of daily living, Participation, Caregiver's Burden
- 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 therapyOther
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 group | Role | What they receive |
|---|---|---|
| occupational therapy | Experimental | Not described Receives: Other: occupational therapy |
| No occupational therapy | No intervention | Patients and their caregivers in the control group will have no occupational therapy intervention until their last measurement has taken place (3 months). |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient: Combination of AMPS-process skills and COPM-performance measure
Measured: 0 and 3 months
Caregiver: Zarit Burden Inventory (ZBI)
Measured: 0 and 3 months
Secondary outcomes (11)
Patient: Assessment of Motor and Process Skills(AMPS)- motor skills
Measured: 0 and 3 months
Patient: Canadian Occupational Performance Measure (COPM)- satisfaction measure
Measured: 0 and 3 months
Patient: Impact on Participation and Autonomy (IPA)
Measured: 0 and 3 months
Patient: AMC Linear Disability Scale (ALDS)
Measured: 0 and 3 months
Patient: Parkinson's Disease Questionnaire 39 (PDQ-39)
Measured: 0 and 3 months
Patient and Caregiver: EQ-5D and VAS
Measured: 0 and 3 months
Patient and caregiver: Resource utilization
Measured: 0 and 3 months
Caregiver: Canadian Occupational Performance Measure (COPM)
Measured: 0 and 3 months
Caregiver: Questionnaire Objective Caregiving Burden
Measured: 0 and 3 months
Caregiver: SF-36
Measured: 0 and 3 months
Patient and caregiver in intervention group: satisfaction with intervention
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Nov 2009 (estimated)
- Study startOct 2009
- Primary completionJun 2010
- Study completionJun 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Parkinson's DiseaseStudies of the same condition, open and under way.
- More trials run by Radboud University Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- 43 participants (actual)
Sponsor and investigators
- Lead sponsor
- Radboud University Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Stichting Nuts Ohra
- Investigators
- Marten Munneke, Phd, Principal investigator, UMC St Radboud
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01010529
- Sponsor's protocol ID
- FNO-0804-66
- Acronym
- OTiP pilot
- Status last verified
- Oct 2010
- First submitted
- 9 Nov 2009
- Last updated
- 18 Mar 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Mar 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility of a Trial Evaluating the Effectiveness of Occupational Therapy in Parkinson's Disease
- ClinicalTrials.gov ID
- NCT01010529
- Acronym / sponsor ID
- OTiP pilot / FNO-0804-66
- Conditions
- Parkinson's Disease
- Keywords
- Occupational Therapy, Parkinson's Disease, Feasibility, Effectiveness, RCT, Activities of daily living, Participation, Caregiver's Burden
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 43 participants (actual)
- Lead sponsor
- Radboud University Medical CenterUniversity, hospital or other
- Collaborators
- Stichting Nuts Ohra
- Study start
- Oct 2009
- Primary completion
- Jun 2010 (actual)
- Study completion
- Jun 2010 (actual)
- First posted
- 10 Nov 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to determine the feasibility of a RCT evaluating the effectiveness of occupational therapy in Parkinson's disease.
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 recently developed Dutch clinical practice guideline for OT in PD offers a good basis for conducting an intervention study. This proposed pilot study is an important step towards setting up a large scale RCT to evaluate the effectiveness of OT in improving daily functioning of patients with PD and reducing caregivers' burden.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| occupational therapy | Experimental | Other: occupational therapy |
| No occupational therapy | No intervention | –Patients and their caregivers in the control group will have no occupational therapy intervention until their last measurement has taken place (3 months). |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- idiopathic Parkinson's Disease according to UK Brain Bank Criteria
- home dwelling
- indication for occupational therapy (according to criteria in the evidence based guideline)
- available to provide informal support minimal two times a week to a patient who participates in the study.
Key exclusion criteria (4 listed)
- not capable of completing the self assessment forms (i.e. due to language or severe cognitive problems)
- comorbidity 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 (IMPACT, PARKFIT, ERGODIM)
- having received occupational therapy intervention in the last 12 months
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| occupational therapyPatients 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. | Other | occupational therapy |
Primary outcome
Patient: Combination of AMPS-process skills and COPM-performance measure
Time frame: 0 and 3 months
Caregiver: Zarit Burden Inventory (ZBI)
Time frame: 0 and 3 months
11 secondary outcomes
Patient: Assessment of Motor and Process Skills(AMPS)- motor skills
Time frame: 0 and 3 months
Patient: Canadian Occupational Performance Measure (COPM)- satisfaction measure
Time frame: 0 and 3 months
Patient: Impact on Participation and Autonomy (IPA)
Time frame: 0 and 3 months
Patient: AMC Linear Disability Scale (ALDS)
Time frame: 0 and 3 months
Patient: Parkinson's Disease Questionnaire 39 (PDQ-39)
Time frame: 0 and 3 months
Patient and Caregiver: EQ-5D and VAS
Time frame: 0 and 3 months
Patient and caregiver: Resource utilization
Time frame: 0 and 3 months
Caregiver: Canadian Occupational Performance Measure (COPM)
Time frame: 0 and 3 months
Caregiver: Questionnaire Objective Caregiving Burden
Time frame: 0 and 3 months
Caregiver: SF-36
Time frame: 0 and 3 months
Patient and caregiver in intervention group: satisfaction with intervention
Time frame: 3 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Mar 2011.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Marten Munneke, Phd principal investigator
UMC St Radboud
4 sites in 1 country: see every site and its status.
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 4 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 4 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 18 Mar 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 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?
Patient: Combination of AMPS-process skills and COPM-performance measure (time frame: 0 and 3 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 18 Mar 2011.