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| Name | Class |
|---|---|
| Princess Beatrix Muscle Foundation | OTHER |
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The purpose of this study is to determine the effectiveness of occupational therapy in Parkinson's disease.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| occupational therapy | Experimental | 10 weeks occupational therapy according to a protocol (OTiP protocol) based on the Dutch guidelines of occupational therapy in Parkinson's disease |
|
| 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 (6 months). |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Occupational Therapy | Behavioral | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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) | 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| Perceive Recall Plan Perform Measure (PRPP) | Observational measure. Activity performance patient | 3 months |
| Zarit Burden Inventory (ZBI) | Perceived caregiver burden.(caregiver) |
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Inclusion criteria patients:
Inclusion criteria caregivers
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Marten Munneke, Phd | Radboud University Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Meander Medisch Centrum | Amersfoort | Netherlands | ||||
| Gelre Ziekenhuizen |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25854809 | Derived | 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. | |
| 24726066 | Derived | 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. |
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| ID | Term |
|---|---|
| D010300 | Parkinson Disease |
| ID | Term |
|---|---|
| D020734 | Parkinsonian Disorders |
| D001480 | Basal Ganglia Diseases |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
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| ID | Term |
|---|---|
| D009788 | Occupational Therapy |
| ID | Term |
|---|---|
| D012046 | Rehabilitation |
| D000359 | Aftercare |
| D003266 | Continuity of Patient Care |
| D005791 | Patient Care |
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|
| 3 months |
| Parkinson's Disease Questionnaire 39 (PDQ-39) | Health related Quality of life (Parkinson specific; patient) | 3 months |
| Resource utilization questionnaire | For evaluating costs. (patient and caregiver) | 3 months |
| Objective Caregiving Burden | Evaluating hours of care (costs). (caregiver) | 3 months |
| Activity Card Sort (ACS) | Participation measure:% retained activities.(patient) | 3 months |
| The Utrecht Scale for evaluation of Rehabilitation Participation (USER-P)(section III) | Satisfaction with participation (patient) | 3 months |
| Becks depression Inventory (BDI) | Mood and Depression. (patient) | 3 months |
| Hospital Anxiety and Depression Scale (HADS) | Mood and depression. (caregiver). | 3 months |
| The Utrecht Proactive Coping Competence list (UPCC) | Proactive coping skills. (patient and caregiver) | 3 months |
| Fatigue Severity Scale (FSS) | Impact of fatigue (patient) | 3 months |
| Canadian Occupational Performance Measure (COPM-satisfaction) | Perceived satisfaction with performance. (patient) | 3 months |
| Quality of life-overall | One question on rating overall quality of life (VAS scale). (patient and caregiver). | 3 months |
| Zarit Burden Inventory (ZBI) | Perceived caregiver burden. (caregiver) | 6 months |
| Parkinson's Disease Questionnaire 39 (PDQ-39) | Health related Quality of life (Parkinson specific) | 6 months |
| Objective Caregiving Burden | Evaluating hours of care (costs). (caregiver). | 6 months |
| Euroqol EQ-5D | Quality of life. Used for patient and caregiver in evaluation of cost effectiveness | 6 months |
| 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. | 6 months |
| Canadian Occupational Performance Measure (COPM-satisfaction) | Perceived satisfaction with performance. (patient) | 6 months |
| The Utrecht Scale for evaluation of Rehabilitation Participation (USER-P)(section III) | Satisfaction with participation (patient) | 6 months |
| Becks depression Inventory (BDI) | Mood and Depression. (patient) | 6 months |
| Hospital Anxiety and Depression Scale (HADS) | Mood and depression. (caregiver). | 6 months |
| The Utrecht Proactive Coping Competence list (UPCC) | Proactive coping skills. (patient and caregiver) | 6 months |
| Fatigue Severity Scale (FSS) | Impact of fatigue (patient) | 6 months |
| Apeldoorn |
| Netherlands |
| Tergooiziekenhuizen | Blaricum | Netherlands |
| Deventer Ziekenhuis | Deventer | Netherlands |
| St Jansdal | Harderwijk | Netherlands |
| Tergooiziekenhuizen | Hilversum | Netherlands |
| St. Antonius | Utrecht | Netherlands |
| Diakonessenhuis | Zeist | Netherlands |
| Gelre Ziekenhuizen | Zutphen | Netherlands |
| Isala Klinieken | Zwolle | Netherlands |
| 23374761 | Derived | 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. |
| D009422 | Nervous System Diseases |
| D009069 | Movement Disorders |
| D000080874 | Synucleinopathies |
| D019636 | Neurodegenerative Diseases |
| D013812 |
| Therapeutics |