Effects of a Dynamic Upper Limb Orthosis in Patients With Parkinson's Disease

June 24, 2022 updated by: Universidad de Burgos

Effects of a Dynamic Upper Limb Orthosis in Reducing Tremor and Rigidity on Patients With Parkinson's Disease: a Randomized Clinical Test Study Protocol

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

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Objective: To assess the effect at 3 and 6 months of the upper limb orthosis, applied for 3 months in the functionality of the affected upper member, manual dexterity, performance of daily living activities and quality of life in Parkinson patients.

Design and setting: A randomized controlled clinical trial of two parallel groups.

Population: 40 patients with tremor and stiffness due to Parkinson´s disease will be included, selected by consecutive sampling at the Neurological Service and Stroke Unit of the Burgos University Hospital (Spain)

. Measurements and intervention: Functionality of the affected upper member, manual dexterity, performance of daily living activities and health-related quality of life will be evaluated. All participants will continue to receive the medical treatment indicated to their health status. The intervention group will receive a treatment based on a dynamic orthosis during 3 months. No additional intervention with the participants of the control group will be completed.

Study Type

Interventional

Enrollment (Anticipated)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Raúl Soto Cámar-, PhD
  • Phone Number: +34 673192039
  • Email: rscamara@ubu.es

Study Contact Backup

  • Name: Jeronimo Javier González-Bernal, PhD
  • Phone Number: +34 947499108
  • Email: jejavier@ubu.es

Study Locations

  • Spain
      • Burgos, Spain, 09006
        • Recruiting
        • Universitary of Burgos
        • Contact:
          • Raul Soto-Cámara, PhD
          • Phone Number: +34 673192039
          • Email: rscamara@ubu.es
        • Contact:
          • Jeronimo Gonzalez-Bernal, PhD
          • Phone Number: +34 947499108
          • Email: jejavier@ubu.es

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 99 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Dynamic Upper Limb Orthosis group

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

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
No Intervention: Control group
The control group will not receive any type of intervention Participants of this group will continue to receive their regular therapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Rigidity of the upper limb
Time Frame: 3 months
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
Time Frame: 3 months
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Manual dexterity of the upper limb
Time Frame: 3 months
Measurement by the Purdue Pegboard Test Reference values according to age, sex and type of activity
3 months
Daily Living Activities
Time Frame: 3 months
Measurement by the Movement Disorders. Society - Unified Parkinson's Disease Rating Scale (MDS-UPDRS) - Subscale II Score between 0 (best functionality) and 52 (worst functionality)
3 months
Emotional state and quality of life.
Time Frame: 3 months
Measurement by the Parkinson's Disease Questionnaire (PDQ-39) The patient points out the frequency of presentation of different situations. It is a quantitative variable; there are no minimum or maximum values; there are no reference values
3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Universidad de Burgos

Collaborators

Castilla-León Health Service

Investigators

  • Principal Investigator: Raúl Soto-Cámara, PhD, University of Burgos
  • Principal Investigator: Jeronimo Javier González-Bernal, PhD, University of Burgos

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2021

Primary Completion (Anticipated)

October 1, 2022

Study Completion (Anticipated)

April 30, 2023

Study Registration Dates

First Submitted

March 22, 2021

First Submitted That Met QC Criteria

March 22, 2021

First Posted (Actual)

March 25, 2021

Study Record Updates

Last Update Posted (Actual)

June 27, 2022

Last Update Submitted That Met QC Criteria

June 24, 2022

Last Verified

June 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • UBU-HUBU: DO

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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