NCT04815382

Brief Summary

This is a randomized controlled clinical trial aimed at Parkinson's disease patients. Its objective is to evaluate the effects of a dynamic upper limb orthosis to achieve maximum hand functionality, reducing tremor and rigidity

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
40

participants targeted

Target at P50-P75 for not_applicable parkinson-disease

Timeline
Completed

Started Jan 2021

Typical duration for not_applicable parkinson-disease

Geographic Reach
1 country

1 active site

Status
unknown

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

January 1, 2021

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

March 22, 2021

Completed
3 days until next milestone

First Posted

Study publicly available on registry

March 25, 2021

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2022

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 30, 2023

Completed
Last Updated

June 27, 2022

Status Verified

June 1, 2022

Enrollment Period

1.7 years

First QC Date

March 22, 2021

Last Update Submit

June 24, 2022

Conditions

Parkinson DiseaseTremor, LimbRigidity, Muscle

Keywords

Parkinson DiseaseTremorRigidityUpper LimbDynamic Orthosis

Outcome Measures

Primary Outcomes (2)

  • Rigidity of the upper limb

    Measurement by the Movement Disorders. Society - Unified Parkinson's Disease Rating Scale (MDS-UPDRS) - Subscale III Score between 0 (best functionality) and 68 (worst functionality)

    3 months

  • Tremor of the upper limb

    Measurement by the Kinesia One Device This device will provide information on the speed, amplitude and rhythm of the tremor of the upper limb. There are no minimum or maximum values

    3 months

Secondary Outcomes (3)

  • Manual dexterity of the upper limb

    3 months

  • Daily Living Activities

    3 months

  • Emotional state and quality of life.

    3 months

Study Arms (2)

Dynamic Upper Limb Orthosis group

EXPERIMENTAL

The dynamic upper limb orthosis group will receive a treatment based on the use of a dynamic upper limb orthosis. Participants of this group will continue to receive their regular therapy

Other: Dynamic Upper Limb Orthosis

Control group

NO INTERVENTION

The control group will not receive any type of intervention Participants of this group will continue to receive their regular therapy

Interventions

Dynamic Upper Limb OrthosisOTHER

The dynamic upper limb orthosis extends from subdeltoid level to 10 mm distal to the metacarpal-phalangeal joints. The orthosis will be tailored to include 20 degrees of wrist extension and to abduct the thumb. They made from nylon and lycra. The orthosis will be used throughout the day, being removed when the patient lies down. The orthosis will be used during 3 months

Dynamic Upper Limb Orthosis group

Eligibility Criteria

Age18 Years - 99 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Diagnosis of Parkinson's disease according to "brain bank" criteria
  • Parkinson's disease stage 1 to 3 according to the Hoehn and Yahr scale

You may not qualify if:

  • Moderate cognitive or language impairment
  • Musculoskeletal or dermatological diseases in the upper limb
  • Impossibility of follow-up for 6 months
  • Difficulty to attend to assessment visits
  • Allergy to glove composition

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Universitary of Burgos

Burgos, 09006, Spain

RECRUITING

MeSH Terms

Conditions

Parkinson DiseaseTremorMuscle Rigidity

Condition Hierarchy (Ancestors)

Parkinsonian DisordersBasal Ganglia DiseasesBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesMovement DisordersSynucleinopathiesNeurodegenerative DiseasesDyskinesiasNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsMuscular DiseasesMusculoskeletal DiseasesMuscle HypertoniaNeuromuscular Manifestations

Study Officials

  • Raúl Soto-Cámara, PhD

    University of Burgos

    PRINCIPAL INVESTIGATOR

  • Jeronimo Javier González-Bernal, PhD

    University of Burgos

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Raúl Soto Cámar-, PhD

CONTACT

+34 673192039rscamara@ubu.es

Jeronimo Javier González-Bernal, PhD

CONTACT

+34 947499108jejavier@ubu.es

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
SPONSOR

Study Record Dates

First Submitted

March 22, 2021

First Posted

March 25, 2021

Study Start

January 1, 2021

Primary Completion

October 1, 2022

Study Completion

April 30, 2023

Last Updated

June 27, 2022

Record last verified: 2022-06

Data Sharing

IPD Sharing
Will not share

Locations

ES(1)