Clinical trial NCT03777501: The Effect of Whole Body Vibration in Individuals With Parkinson's Disease
Official title: The Effect of Whole Body Vibration on Sensorimotor Function in Individuals With Parkinson's Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Parkinson Disease
Keywords: proprioception
vibration
balance
Lead sponsor: Chang Gung University
Sponsor class: OTHER
First posted: 2018-12-17
Enrollment: 34
Sex: ALL
Minimum age (years): 50
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: randomized double-blinded controlled trial
Primary purpose: TREATMENT

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?


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

Primary outcomes:
measure: Change in just noticeable difference threshold of proprioceptive sensitivity
timeFrame: baseline, 1 day and 4 weeks
measure: Change of position sense of the knee joint
timeFrame: baseline, 1 day and 4 weeks
measure: Change of Unified Parkinson's disease rating scale-motor (UPDRS motor)
timeFrame: baseline, 1 day and 4 weeks
measure: Change of balance function (measured by Functional Reach Test)
timeFrame: baseline, 1 day and 4 weeks
measure: Change of mobility function (measured by Time up and go test)
timeFrame: baseline, 1 day and 4 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Linkou
country: Taiwan
facility: Chang Gung Memorial Hospital
Study officials:
References: