Clinical trial NCT03916770: The Effect of Whole Body Vibration (WBV) on Spasticity in Poststroke Hemiplegia
Official title: The Effect of Whole Body Vibration on Spasticity in Poststroke Hemiplegia:Prospective Randomized Controlled Research
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Muscle Spasticity
Physiology
Keywords: muscle
vibration
H reflex
H/M ratio
spasticity
Lead sponsor: Istanbul Physical Medicine Rehabilitation Training and Research Hospital
Sponsor class: OTHER_GOV
First posted: 2019-04-16
Enrollment: 48
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Whole Body Vibration (WBV) will be applied to Poststroke Hemiplegia. The patients are divided in two groups; WBV group and shame WBV group.
Primary purpose: TREATMENT

Brief summary: The primary purpose of this study is to show whether WBV application has antispastic effect. The secondary aim is to demonstrate whether WBV has neuromodulatory activity on increased stretch reflex and motor neuron activity, which is the basis of the pathophysiology of spasticity.Hypotheses of this study:Whole body vibration in poststroke hemiplegia reduces ankle plantar flexion spasticity.

1. WBV ; reduces plantar flexor spasticity after stroke
2. WBV decreases poststroke spasticity, by decreasing increased stretch reflex and motor neuron activity.

Detailed description: Patients with a stroke of at least 1 month before and with a history of ankle plantar flexion spasticity will be included in the study. Conventional rehabilitation program will be applied to all patients (n=48).The intervention group (n=24) will be applied for 4 weeks, 3days a week, a total of 12 sessions with the WBV powerplate pro5 device. In the WBV group, the frequency and acceleration of vibration will be 30Hz and 18.0m/s2, respectively. The WBV exercise intensity will progressively increase throughout the twelve-session. In the control group, the same procedures will be followed. However, unlike the WBV group, a vibration will be given whose acceleration is attenuated by 99.5%.The surface Electromyography (EMG) and degree of spasticity of soleus muscle will be evaluated at the beginning and end of the all sessions. Soleus H-reflex will be recorded with surface EMG.To obtain the H-reflex response, the posterior tibial nerve in the popliteal region will be stimulated by using a stimulator (FE155 Stimulator HC ADInstrument, Oxford UK) with 1 ms-pulse current. The records will be taken with the Ag / AgCl electrodes (Kendall ®Coviden, self-adhesive electrodes) placed on skin according to the SENIAM protocol. The degree of spasticity will be measured as a soleus muscle tone torque on a fixed angular velocity moving platform.The data will be recorded with the PowerLab data acquisition device

Eligibility criteria: Inclusion Criteria:

1. Ischemic / hemorrhagic poststroke hemiplegia aged 18-90 years,
2. Stroke time ≥1 months,
3. Ankle plantar flexor spasticity MAS ≥1,
4. Brunnstrom stage ≥3 for lower extremity,
5. Patients who were standing for more than five minutes and had a static balance

Exclusion Criteria:

1. Cardiac disorder (rhythm / conduction disorder, cardiac pacemaker, ischemic heart disease)
2. Lower extremity fracture,
3. Findings or suspicion of active deep vein thrombosis,
4. A history of deep vein thrombosis and pulmonary embolism,
5. Orthostatic hypotension
6. Resistant hypertension,
7. Peripheral nerve lesions such as polyneuropathy, radiculopathy
8. Active inflammatory, rheumatologic or infectious disease,
9. Ankle,knee or hip joint contracture,
10. Presence of panic attacks,
11. Patients with dizziness and balance problems,
12. Patients with not intact skin surface to connect electrodes
13. Patients with communication problems: aphasia, major depression
14. Epilepsy
15. Patients who received botulinum A toxin in the last 6 months

Primary outcomes:
measure: spasticity-torque
timeFrame: 4 weeks
measure: spasiticity-modified Ashworth scale
timeFrame: 4 weeks
measure: spasticity-homosynaptic post-activation depression (HPAD)
timeFrame: 4 weeks
measure: Motor neuron activity-Hmax / Mmax ratio
timeFrame: 4 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Istanbul Physical Medicine Rehabilitation Training and Research Hospital Istanbul, Turkey
Study officials:
affiliation: Istanbul Physical Medicine Rehabilitation Training and Research Hospital
name: Ayşenur Bardak, Prof
role: STUDY_CHAIR
References:
citation: Chan KS, Liu CW, Chen TW, Weng MC, Huang MH, Chen CH. Effects of a single session of whole body vibration on ankle plantarflexion spasticity and gait performance in patients with chronic stroke: a randomized controlled trial. Clin Rehabil. 2012 Dec;26(12):1087-95. doi: 10.1177/0269215512446314. Epub 2012 Oct 3.
citation: Pang MY, Lau RW, Yip SP. The effects of whole-body vibration therapy on bone turnover, muscle strength, motor function, and spasticity in chronic stroke: a randomized controlled trial. Eur J Phys Rehabil Med. 2013 Aug;49(4):439-50. Epub 2013 Mar 13.
citation: Miyara K, Matsumoto S, Uema T, Noma T, Ikeda K, Ohwatashi A, Kiyama R, Shimodozono M. Effect of whole body vibration on spasticity in hemiplegic legs of patients with stroke. Top Stroke Rehabil. 2018 Mar;25(2):90-95. doi: 10.1080/10749357.2017.1389055. Epub 2017 Oct 16.
citation: Brogardh C, Flansbjer UB, Lexell J. No specific effect of whole-body vibration training in chronic stroke: a double-blind randomized controlled study. Arch Phys Med Rehabil. 2012 Feb;93(2):253-8. doi: 10.1016/j.apmr.2011.09.005.
citation: Alp A, Efe B, Adali M, Bilgic A, Demir Ture S, Coskun S, Karabulut M, Ertem U, Gunay SM. The Impact of Whole Body Vibration Therapy on Spasticity and Disability of the Patients with Poststroke Hemiplegia. Rehabil Res Pract. 2018 May 2;2018:8637573. doi: 10.1155/2018/8637573. eCollection 2018.