The Effect of Whole Body Vibration (WBV) on Spasticity in Poststroke Hemiplegia

Muscle Spasticity Clinical Trial

— WBV  

Official title:

The Effect of Whole Body Vibration on Spasticity in Poststroke Hemiplegia:Prospective Randomized Controlled Research

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03916770
• Other study ID #: IstPMRTRH-BMR
• Status: Completed
• Phase: N/A
• Start date: August 1, 2019
• Est. completion date: August 1, 2020

Study information

• Verified date: December 2021
• Source: Istanbul Physical Medicine Rehabilitation Training and Research Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 48
• Est. completion date: August 1, 2020
• Est. primary completion date: March 1, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

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

Related Conditions & MeSH terms

• Hemiplegia
• Muscle Spasticity
• Physiology

Intervention

Device:
• Sham vibrator
The Sham control group will have WBV the same time,in the same position with the same frequency but 99.5% weakened amplitude.
• Real vibrator
The intervention group will have WBV(frequency:30Hz,amplitude:2,2mm,at upright position

Locations

Country	Name	City	State
Turkey	Istanbul Physical Medicine Rehabilitation Training and Research Hospital Istanbul, Turkey	Istanbul

Sponsors (1)

Lead Sponsor	Collaborator
Istanbul Physical Medicine Rehabilitation Training and Research Hospital

Country where clinical trial is conducted

Turkey, 

References & Publications (5)

Alp A, Efe B, Adali M, Bilgiç A, Demir Türe S, Coskun S, Karabulut M, Ertem U, Günay 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. — View Citation

Brogårdh 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. — View 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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	spasticity-torque	Spasticity will be measured as a torque. The unit is Nm	4 weeks
Primary	spasiticity-modified Ashworth scale	The spasticity degree of the plantar flexors will be evaluated by using a subjective assessment method (modified Ashworth scale-MAS)	4 weeks
Primary	spasticity-homosynaptic post-activation depression (HPAD)	Homosynaptic post-activation depression is a presynaptic mechanism regulating the excitability of the stretch reflex. Decreased presynaptic inhibition and homosynaptic depression are also thought to play a role in the pathophysiology of spasticity. The higher HPAD, the lower spasticity	4 weeks
Primary	Motor neuron activity-Hmax / Mmax ratio	Hmax / Mmax ratio defines motor neuron activity. The higher this ratio, the higher the activity of motor neuron pool	4 weeks