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

Universidad de Burgos

Status: Enrolling

Conditions: Rigidity, Muscle; Tremor, Limb; Parkinson Disease

Treatments: Other: Dynamic Upper Limb Orthosis

Study type: Interventional

Funder types: Other

Identifiers

NCT04815382

UBU-HUBU: DO

Details and patient eligibility

About

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

Full 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.

Enrollment: 40 estimated patients

Sex: All

Ages: 18 to 99 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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40 participants in 2 patient groups

Dynamic Upper Limb Orthosis group

Experimental group

Description:

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

Treatment:

Other: Dynamic Upper Limb Orthosis

Control group

No Intervention group

Description:

The control group will not receive any type of intervention Participants of this group will continue to receive their regular therapy