NCT02938819

Brief Summary

Upper-limb disorders in patients with Parkinson's disease include decreased speed and amplitude of movements, difficulty in sequential tasks, and disrupted execution of fine manipulative hand activities.The aim of the study was to evaluate the effects of home-based goal-oriented upper limb intervention in patients with Parkinson's disease.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
54

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Aug 2016

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2016

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2016

Completed
16 days until next milestone

First Submitted

Initial submission to the registry

October 17, 2016

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 19, 2016

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2016

Completed
Last Updated

December 14, 2016

Status Verified

December 1, 2016

Enrollment Period

2 months

First QC Date

October 17, 2016

Last Update Submit

December 13, 2016

Conditions

Keywords

upper limbsphysiotherapy

Outcome Measures

Primary Outcomes (1)

  • Goals attainment

    Attainment of goals was assessed using the Goal Attainment Scaling, a method for quantifying progress on the achievement of specific goals

    Change from baseline goals attainment assessment at 4 weeks.

Secondary Outcomes (3)

  • Manual dexterity

    Change from baseline manual dexterity at 4 weeks

  • Handgrip strength

    Change from baseline handgrip strength at 4 weeks

  • Finger prehension force

    Change from baseline finger prehension force at 4 weeks

Study Arms (2)

Experimental group

EXPERIMENTAL

Patients in the experimental group received a Goal-oriented upper limb intervention.

Other: Goal-oriented upper-limb intervention

Control group

ACTIVE COMPARATOR

Patients in the control group received a standard upper limb intervention

Other: Standard upper limb intervention

Interventions

The Goal-oriented upper-limb intervention evaluated patients' expectations and the environmental factors influencing the performance of the specific task were identified for each of the three tasks. Patients were asked to perform the activity at home. After this, the observable target behavior corresponding to the target activity was determined. Then, an occupational and a physical therapist worked together with the patient to identify the assistance required to perform this activity such as human assistance, technical aids, assistive devices or verbal guidance.

Experimental group

The standard upper limb intervention involved active upper limb range of motion, manual dexterity involving grasp and manipulation of small pieces such as marbles and stretching upper limb exercises.

Control group

Eligibility Criteria

Age50 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Clinical diagnosis of Parkinson's Disease.
  • Stage II-III of disease progression as defined by the Hoehn and Yahr scale.
  • Upper limbs impairment

You may not qualify if:

  • Clinical signs of dementia or psychiatric disturbance.
  • Comprehension deficits that prevented them from following verbal commands.
  • Visual or acoustic limitations.
  • A neurologic condition other than Parkinson's Disease.
  • Musculoskeletal disorders and/or if they had previous trauma or fracture of upper extremity.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Physical Therapy

Granada, Granada, 18071, Spain

Location

MeSH Terms

Conditions

Parkinson Disease

Condition Hierarchy (Ancestors)

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

Study Officials

  • Marie Carmen Valenza, PhD

    Universidad de Granada

    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
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PhD

Study Record Dates

First Submitted

October 17, 2016

First Posted

October 19, 2016

Study Start

August 1, 2016

Primary Completion

October 1, 2016

Study Completion

December 1, 2016

Last Updated

December 14, 2016

Record last verified: 2016-12

Locations