The Effect of Whole Body Vibration in Individuals With Parkinson's Disease

NCT ID: NCT03777501

Last Updated: 2020-01-23

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 34 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-12-28
• Study Completion Date: 2019-06-28

Brief Summary

Previous studies reported that whole body vibration has the potential impact on balance and walking abilities in individuals with Parkinson's disease; however, the inconsistent treatment protocols and different experimental designs lead to inconclusive results. Therefore, the purpose of this study is to investigate the short term and long term effect of whole body vibration on sensorimotor function in individuals with Parkinson's disease. The experimental design will be randomized double-blinded controlled trial. Sixty individuals with idiopathic Parkinson's disease will be randomly assigned to two groups and they are non-random whole body vibration group and conventional therapy group. Each participant will receive the treatment about one hour after the administration of medicine. For non-random whole body vibration group, participants will be required to maintain the erect standing position on the vibratory platform and the frequency and amplitude of vibratory stimuli will be 6Hz and 3mm respectively. Each treatment includes five sessions and each session is composed of one minute whole body vibration and one minute rest. For the conventional therapy group, participants will receive the occupational therapy including dynamic balance training and functional ambulatory training. Each session is 10 minutes in both groups and all participants will receive one and twelve treatment sessions for short-term and long-term effect respectively. Outcome measures include proprioceptive sensitivity threshold of upper limb, position sense test of the knee joint, Unified Parkinson's disease rating scale-motor (UPDRS motor), functional reach, and time up and go test (TUG). Specifically, the investigators want to answer the following four questions: 1) Is there any difference in proprioceptive sensitivity, motor performance and balance before and after treatment in individuals with Parkinson's disease? 2) Is there any difference in short-term and long term effect of whole body vibration in individuals with Parkinson's disease? 3) Is there any difference in treatment effect in individuals with Parkinson's disease in Taiwan?

Conditions

Parkinson Disease

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

non-random whole body vibration group

Each participant will receive the non-random type whole body vibration treatment about one hour after the administration of medicine.

Group Type: EXPERIMENTAL

non-random whole body vibration

Intervention Type: BEHAVIORAL

Each participant will receive the treatment about one hour after the administration of medicine. For non-random whole body vibration group, participants will be required to maintain the erect standing position on the vibratory platform and the frequency and amplitude of vibratory stimuli will be 6Hz and 3mm respectively. Each treatment includes five sessions and each session is composed of one minute whole body vibration and one minute rest.

conventional therapy group

For the conventional therapy group, participants will receive the occupational therapy including dynamic balance training and functional ambulatory training. Each session is 10 minutes.

Group Type: ACTIVE_COMPARATOR

occupational therapy

Intervention Type: BEHAVIORAL

Participants will receive the occupational therapy including dynamic balance training and functional ambulatory training.

Interventions

non-random whole body vibration

Each participant will receive the treatment about one hour after the administration of medicine. For non-random whole body vibration group, participants will be required to maintain the erect standing position on the vibratory platform and the frequency and amplitude of vibratory stimuli will be 6Hz and 3mm respectively. Each treatment includes five sessions and each session is composed of one minute whole body vibration and one minute rest.

Intervention Type: BEHAVIORAL

occupational therapy

Participants will receive the occupational therapy including dynamic balance training and functional ambulatory training.

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• agree to sign the informed consent form.
• diagnosed with idiopathic Parkinson's disease with Hoehn and Yahr stage 2~3
• cognitive impairment (Mini-Mental State Examination [MMSE] score greater than 24 points
• no depression as evaluated by the Beck Depression Inventory
• no severe arm injuries or shoulder dislocation which might interfere with proprioceptive function
• can perform reaching movement
• no diagnosed peripheral nerve disorders or other neurologic conditions
• no severe tremor which might interfere with the measurement proprioceptive function

Exclusion Criteria

• diagnosed with other central nervous system diseases, ex: stroke
• had surgeries in head or arms
• unable to sit for assessment

• Minimum Eligible Age: 50 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Chang Gung University

OTHER

Sponsor Role: lead

Responsible Party

Kuan-yi Li

Associate professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Chang Gung Memorial Hospital

Linkou District, , Taiwan

Countries

Taiwan

Other Identifiers

201702010B0C603

Identifier Type: -

Identifier Source: org_study_id