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

Parkinson Disease Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04815382
• Other study ID #: UBU-HUBU: DO
• Status: Recruiting
• Phase: N/A
• Start date: January 1, 2021
• Est. completion date: April 30, 2023

Study information

• Verified date: June 2022
• Source: Universidad de Burgos
• Contact: Raúl Soto Cámar-, PhD
• Phone: +34 673192039
• Email: rscamara[@]ubu.es
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: April 30, 2023
• Est. primary completion date: October 1, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 99 Years

Eligibility

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

Related Conditions & MeSH terms

• Muscle Rigidity
• Parkinson Disease
• Rigidity, Muscle
• Tremor
• Tremor, Limb

Intervention

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

Locations

Country	Name	City	State
Spain	Universitary of Burgos	Burgos

Sponsors (2)

Lead Sponsor	Collaborator
Universidad de Burgos	Castilla-León Health Service

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Secondary	Manual dexterity of the upper limb	Measurement by the Purdue Pegboard Test Reference values according to age, sex and type of activity	3 months
Secondary	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)	3 months
Secondary	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