Parkinson Disease, Rigidity, Muscle, Tremor, Limb
Conditions
Keywords
Parkinson Disease, Tremor, Rigidity, Upper Limb, Dynamic Orthosis
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.
Interventions
OTHERDynamic 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
Sponsors
Castilla-León Health Service
Universidad de Burgos
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 99 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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) |
| 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 |
Countries
Spain
Contacts
Primary ContactRaúl Soto Cámar-, PhD
Backup ContactJeronimo Javier González-Bernal, PhD
Outcome results
None listed