NCT03763955

Brief Summary

Aims of the study are (1) to evaluate the effectiveness of a specific OT treatment aimed to enhance finger and hand dexterity and (2) its impact on daily living autonomy of PD patients.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
482

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2015

Typical duration for all trials

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

January 1, 2015

Completed
3.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2018

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

November 26, 2018

Completed
8 days until next milestone

First Posted

Study publicly available on registry

December 4, 2018

Completed
Last Updated

December 4, 2018

Status Verified

November 1, 2018

Enrollment Period

3.6 years

First QC Date

November 26, 2018

Last Update Submit

December 2, 2018

Conditions

Outcome Measures

Primary Outcomes (1)

  • O'Connor Finger Dexterity Test

    peg-placement test aimed to evaluate the ability to manipulate small objects

    4 weeks

Secondary Outcomes (1)

  • Minnesota Manual Dexterity Test

    4 weeks

Study Arms (1)

PD patients

PD patients at 1-5 H\&Y stage undergoes 4week Multidisciplinary Intensive Rehabilitation Treatment

Behavioral: MIRT

Interventions

MIRTBEHAVIORAL

4 week MIRT provide: 1. front to front treatment (1 hour/day for 5 days/week) 2. treatment with robotic devices (1 hour/day for 5 days/week) 3. occupational therapy (1 hour/day for 5 days/week)

Also known as: Multidisciplinary Intensive Rehabilitation Treatment
PD patients

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Parkinsonian inpatients

You may qualify if:

  • diagnosis of Parkinson's Disease

You may not qualify if:

  • other neurological disease
  • psychosis
  • auditive or visual deficit

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Parkinson Disease

Condition Hierarchy (Ancestors)

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

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
OTHER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 26, 2018

First Posted

December 4, 2018

Study Start

January 1, 2015

Primary Completion

August 1, 2018

Study Completion

August 1, 2018

Last Updated

December 4, 2018

Record last verified: 2018-11