NCT01010529

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
43

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Oct 2009

Shorter than P25 for not_applicable

Geographic Reach
1 country

4 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2009

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

November 9, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

November 10, 2009

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2010

Completed
Last Updated

March 18, 2011

Status Verified

October 1, 2010

Enrollment Period

8 months

First QC Date

November 9, 2009

Last Update Submit

March 17, 2011

Conditions

Parkinson's Disease

Keywords

Occupational TherapyParkinson's DiseaseFeasibilityEffectivenessRCTActivities of daily livingParticipationCaregiver's Burden

Outcome Measures

Primary Outcomes (2)

  • Patient: Combination of AMPS-process skills and COPM-performance measure

    0 and 3 months

  • Caregiver: Zarit Burden Inventory (ZBI)

    0 and 3 months

Secondary Outcomes (11)

  • Patient: Assessment of Motor and Process Skills(AMPS)- motor skills

    0 and 3 months

  • Patient: Canadian Occupational Performance Measure (COPM)- satisfaction measure

    0 and 3 months

  • Patient: Impact on Participation and Autonomy (IPA)

    0 and 3 months

  • Patient: AMC Linear Disability Scale (ALDS)

    0 and 3 months

  • Patient: Parkinson's Disease Questionnaire 39 (PDQ-39)

    0 and 3 months

  • +6 more secondary outcomes

Study Arms (2)

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).

Interventions

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.

occupational therapy

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Meander Medisch Centrum, locatie Elisabeth

Amersfoort, 3816CP, Netherlands

Location

Gelre Ziekenhuizen, locatie Lukas

Apeldoorn, 7300DS, Netherlands

Location

Alysis Zorggroep, Ziekenhuis Rijnstate

Arnhem, 6800TA, Netherlands

Location

Ziekenhuis Rivierenland Tiel

Tiel, 4000HA, Netherlands

Location

MeSH Terms

Conditions

Parkinson Disease

Interventions

Occupational Therapy

Condition Hierarchy (Ancestors)

Parkinsonian DisordersBasal Ganglia DiseasesBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesMovement DisordersSynucleinopathiesNeurodegenerative Diseases

Intervention Hierarchy (Ancestors)

RehabilitationAftercareContinuity of Patient CarePatient CareTherapeutics

Study Officials

  • Marten Munneke, Phd

    UMC St Radboud

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

November 9, 2009

First Posted

November 10, 2009

Study Start

October 1, 2009

Primary Completion

June 1, 2010

Study Completion

June 1, 2010

Last Updated

March 18, 2011

Record last verified: 2010-10

Locations

NL(4)