Effects of a Dynamic Upper Limb Orthosis in Patients With Parkinson's Disease
NCT ID: NCT04815382
Last Updated: 2022-06-27
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
40 participants
INTERVENTIONAL
2021-01-01
2023-04-30
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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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
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
Control group
The control group will not receive any type of intervention Participants of this group will continue to receive their regular therapy
No interventions assigned to this group
Interventions
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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
Eligibility Criteria
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Inclusion Criteria
* Parkinson's disease stage 1 to 3 according to the Hoehn and Yahr scale
Exclusion Criteria
* 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
18 Years
99 Years
ALL
No
Sponsors
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Castilla-León Health Service
OTHER
Universidad de Burgos
OTHER
Responsible Party
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Principal Investigators
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Raúl Soto-Cámara, PhD
Role: PRINCIPAL_INVESTIGATOR
University of Burgos
Jeronimo Javier González-Bernal, PhD
Role: PRINCIPAL_INVESTIGATOR
University of Burgos
Locations
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Universitary of Burgos
Burgos, , Spain
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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UBU-HUBU: DO
Identifier Type: -
Identifier Source: org_study_id
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