NCT04815382

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

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

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 40 (estimated)
• Sponsor: Universidad de Burgos · Academic / Other
• Sex: All
• Age: 18 Years – 99 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Parkinson Disease
• Tremor, Limb
• Rigidity, Muscle

Interventions

Type	Name	Description
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

Timeline

• Start date: 2021-01-01
• Primary completion: 2022-10-01
• Completion: 2023-04-30
• First posted: 2021-03-25
• Last updated: 2022-06-27

Locations

1 site across 1 country: Spain