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

Study Overview
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Brief Summary
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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

Detailed Description
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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.

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

Conditions
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Parkinson Disease, Tremor, Limb, Rigidity, Muscle

Intervention / Treatment
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* Other: Dynamic Upper Limb Orthosis


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 99 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Dynamic Upper Limb Orthosis group<br>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<br>* 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<br>|
| No Intervention: Control group<br>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?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Manual dexterity of the upper limb | Measurement by the Purdue Pegboard Test Reference values according to age, sex and type of activity | 3 months | 
| Daily Living Activities | 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. | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Parkinson Disease, Tremor, Rigidity, Upper Limb, Dynamic Orthosis