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Completed

NCT Number: NCT01336127

Effectiveness Study of Occupational Therapy in Parkinson's Disease

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

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Key information

Conditions

Parkinson's Disease Basal Ganglia Diseases Brain Diseases Central Nervous System Diseases Movement Disorders Nervous System Diseases Neurodegenerative Diseases Parkinson Disease Parkinsonian Disorders Synucleinopathies

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Meander Medisch Centrum, Amersfoort, Netherlands

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

patients:

  • Idiopathic Parkinson's Disease
  • Indication for referral to occupational therapy
  • Home dwelling

Inclusion criteria

caregivers

  • Available for informal support minimal two times a week to a patient who participates in the study
  • Available to take part in the intervention

Exclusion criteria

  • 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

Treatment and study plan

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.

Primary outcomes

  1. Canadian Occupational Performance Measure (COPM)

    Time frame: 3 months

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

Secondary outcomes

  1. Perceive Recall Plan Perform Measure (PRPP)

    Time frame: 3 months

    Observational measure. Activity performance patient

  2. Zarit Burden Inventory (ZBI)

    Time frame: 3 months

    Perceived caregiver burden.(caregiver)

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

    Time frame: 3 months

    Health related Quality of life (Parkinson specific; patient)

  4. Resource utilization questionnaire

    Time frame: 3 months

    For evaluating costs. (patient and caregiver)

  5. Objective Caregiving Burden

    Time frame: 3 months

    Evaluating hours of care (costs). (caregiver)

  6. Activity Card Sort (ACS)

    Time frame: 3 months

    Participation measure:% retained activities.(patient)

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

    Time frame: 3 months

    Satisfaction with participation (patient)

  8. Becks depression Inventory (BDI)

    Time frame: 3 months

    Mood and Depression. (patient)

  9. Hospital Anxiety and Depression Scale (HADS)

    Time frame: 3 months

    Mood and depression. (caregiver).

  10. The Utrecht Proactive Coping Competence list (UPCC)

    Time frame: 3 months

    Proactive coping skills. (patient and caregiver)

  11. Fatigue Severity Scale (FSS)

    Time frame: 3 months

    Impact of fatigue (patient)

  12. Canadian Occupational Performance Measure (COPM-satisfaction)

    Time frame: 3 months

    Perceived satisfaction with performance. (patient)

  13. Quality of life-overall

    Time frame: 3 months

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

  14. Zarit Burden Inventory (ZBI)

    Time frame: 6 months

    Perceived caregiver burden. (caregiver)

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

    Time frame: 6 months

    Health related Quality of life (Parkinson specific)

  16. Objective Caregiving Burden

    Time frame: 6 months

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

  17. Euroqol EQ-5D

    Time frame: 6 months

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

  18. Canadian Occupational Performance Measure (COPM)

    Time frame: 6 months

    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.

  19. Canadian Occupational Performance Measure (COPM-satisfaction)

    Time frame: 6 months

    Perceived satisfaction with performance. (patient)

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

    Time frame: 6 months

    Satisfaction with participation (patient)

  21. Becks depression Inventory (BDI)

    Time frame: 6 months

    Mood and Depression. (patient)

  22. Hospital Anxiety and Depression Scale (HADS)

    Time frame: 6 months

    Mood and depression. (caregiver).

  23. The Utrecht Proactive Coping Competence list (UPCC)

    Time frame: 6 months

    Proactive coping skills. (patient and caregiver)

  24. Fatigue Severity Scale (FSS)

    Time frame: 6 months

    Impact of fatigue (patient)

Sponsors and collaborators

Lead sponsor

Radboud University Medical Center

Other

Collaborators

  • Princess Beatrix Muscle Foundation

Registry information

Official study title

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

Acronym: OTiP

Important dates

Study start
2011
Primary completion
2013
Study completion
2013
First posted
Apr 15, 2011
Registry last updated
Aug 27, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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