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

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ClinicalTrials.gov Identifier: NCT04815382
Recruitment Status : Recruiting
First Posted : March 25, 2021
Last Update Posted : April 1, 2021
Sponsor:
Collaborator:
Castilla-León Health Service
Information provided by (Responsible Party):
Universidad de Burgos

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

Condition or disease Intervention/treatment Phase
Parkinson Disease Tremor, Limb Rigidity, Muscle Other: Dynamic Upper Limb Orthosis Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Effects of a Dynamic Upper Limb Orthosis in Reducing Tremor and Rigidity on Patients With Parkinson's Disease: a Randomized Clinical Test Study Protocol
Actual Study Start Date : January 1, 2021
Estimated Primary Completion Date : June 1, 2022
Estimated Study Completion Date : December 31, 2022

Resource links provided by the National Library of Medicine


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



Primary Outcome Measures :
  1. 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)

  2. 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


Secondary Outcome Measures :
  1. 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

  2. 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. 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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 99 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04815382


Contacts
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Contact: Raúl Soto Cámar-, PhD +34 673192039 rscamara@ubu.es
Contact: Jeronimo Javier González-Bernal, PhD +34 947499108 jejavier@ubu.es

Locations
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Spain
Universitary of Burgos Recruiting
Burgos, Spain, 09006
Contact: Raul Soto-Cámara, PhD    +34 673192039    rscamara@ubu.es   
Contact: Jeronimo Gonzalez-Bernal, PhD    +34 947499108    jejavier@ubu.es   
Sponsors and Collaborators
Universidad de Burgos
Castilla-León Health Service
Investigators
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Principal Investigator: Raúl Soto-Cámara, PhD University of Burgos
Principal Investigator: Jeronimo Javier González-Bernal, PhD University of Burgos
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Responsible Party: Universidad de Burgos
ClinicalTrials.gov Identifier: NCT04815382    
Other Study ID Numbers: UBU-HUBU: DO
First Posted: March 25, 2021    Key Record Dates
Last Update Posted: April 1, 2021
Last Verified: March 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Universidad de Burgos:
Parkinson Disease
Tremor
Rigidity
Upper Limb
Dynamic Orthosis
Additional relevant MeSH terms:
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Muscle Rigidity
Parkinson Disease
Tremor
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Movement Disorders
Neurodegenerative Diseases
Dyskinesias
Neurologic Manifestations
Muscular Diseases
Musculoskeletal Diseases
Muscle Hypertonia
Neuromuscular Manifestations