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
|Condition or disease||Intervention/treatment||Phase|
|Parkinson Disease Tremor, Limb Rigidity, Muscle||Other: Dynamic Upper Limb Orthosis||Not Applicable|
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 (Clinical Trial)|
|Estimated Enrollment :||40 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Outcomes Assessor)|
|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|
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
- 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)
- 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
- 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
- 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)
- 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
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
|Contact: Raúl Soto Cámar-, PhD||+34 email@example.com|
|Contact: Jeronimo Javier González-Bernal, PhD||+34 firstname.lastname@example.org|
|Principal Investigator:||Raúl Soto-Cámara, PhD||University of Burgos|
|Principal Investigator:||Jeronimo Javier González-Bernal, PhD||University of Burgos|