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

Not Applicable

• Conditions: Tremor, Limb; Rigidity, Muscle; Parkinson Disease
• Interventions: Other: Dynamic Upper Limb Orthosis

• Registration Number: NCT04815382
• Lead Sponsor: 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

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.

Study Timeline

• Study Start: 2021-01-01
• Study First Submitted: 2021-03-22
• Study First Submitted QC: 2021-03-22
• Study First Posted: 2021-03-25
• Status Verified: 2022-06
• Last Update Submitted: 2022-06-24
• Last Update Posted: 2022-06-27
• Primary Completion: 2022-10-01
• Study Completion: 2023-04-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 40

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Dynamic Upper Limb Orthosis group	Dynamic Upper Limb Orthosis	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

Primary Outcome Measures

Name	Time	Method
Rigidity of the upper limb	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	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

Name	Time	Method
Emotional state and quality of life.	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
Manual dexterity of the upper limb	3 months	Measurement by the Purdue Pegboard Test Reference values according to age, sex and type of activity
Daily Living Activities	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)

Trial Locations

Locations (1)

Universitary of Burgos; 🇪🇸 Burgos, Spain