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| Name | Class |
|---|---|
| Castilla-León Health Service | OTHER |
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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
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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
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| 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 |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dynamic Upper Limb Orthosis | Other | 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 |
| 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 |
| 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) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Raúl Soto Cámar-, PhD | Contact | +34 673192039 | rscamara@ubu.es | |
| Jeronimo Javier González-Bernal, PhD | Contact | +34 947499108 | jejavier@ubu.es |
| Name | Affiliation | Role |
|---|---|---|
| Raúl Soto-Cámara, PhD | University of Burgos | Principal Investigator |
| Jeronimo Javier González-Bernal, PhD | University of Burgos | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Universitary of Burgos | Recruiting | Burgos | 09006 | Spain |
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| ID | Term |
|---|---|
| D010300 | Parkinson Disease |
| D014202 | Tremor |
| D009127 | Muscle Rigidity |
| ID | Term |
|---|---|
| D020734 | Parkinsonian Disorders |
| D001480 | Basal Ganglia Diseases |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
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|
| 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 |
| D009422 | Nervous System Diseases |
| D009069 | Movement Disorders |
| D000080874 | Synucleinopathies |
| D019636 | Neurodegenerative Diseases |
| D020820 | Dyskinesias |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D009135 | Muscular Diseases |
| D009140 | Musculoskeletal Diseases |
| D009122 | Muscle Hypertonia |
| D020879 | Neuromuscular Manifestations |