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

NCT03916770 | Completed

• 1 other identifier: IstPMRTRH-BMR
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

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

Conditions

Muscle Spasticity; Physiology

Keywords

muscle; vibration; H reflex; H/M ratio; spasticity

Outcome Measures

Primary Outcomes (4)

• spasticity-torque

  Spasticity will be measured as a torque. The unit is Nm

  4 weeks

• 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

• 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

• 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

Study Arms (2)

whole body vibration

ACTIVE COMPARATOR

WBV(whole body vibration) will be applied to interventional group for 4 weeks, 3 days a week, a total of 12 sessions while standing upright with the WBV powerplate pro5 device.(Vibration frequency: 30Hz, amplitude: 2.2 mm at progressively increasing duration)

Device: Real vibrator

Sham whole body vibration

SHAM COMPARATOR

The sham WBV will be applied to the Control group. A WBV device with 99.5% weakened amplitude will be used for sham WBV. (Application duration of the sham WBV will be same as WBV in the treatment group ).

Device: Sham vibrator

Interventions

Sham vibrator DEVICE

The Sham control group will have WBV the same time,in the same position with the same frequency but 99.5% weakened amplitude.

Also known as: Sham WBV

Sham whole body vibration

Real vibrator DEVICE

The intervention group will have WBV(frequency:30Hz,amplitude:2,2mm,at upright position

Also known as: Real WBV

whole body vibration

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Istanbul Physical Medicine Rehabilitation Training and Research Hospital: lead

Study Sites (1)

Istanbul Physical Medicine Rehabilitation Training and Research Hospital Istanbul, Turkey

Istanbul, Turkey (Türkiye)

Location

Related Publications (5)

• 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.

  PMID: 23035004 BACKGROUND

• 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.

  PMID: 23486302 BACKGROUND

• 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.

  PMID: 29032720 BACKGROUND

• 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.

  PMID: 22289234 BACKGROUND

• 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.

  PMID: 30225145 BACKGROUND

MeSH Terms

Conditions

Muscle Spasticity

Condition Hierarchy (Ancestors)

Muscular Diseases; Musculoskeletal Diseases; Muscle Hypertonia; Neuromuscular Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Ayşenur Bardak, Prof

  Istanbul Physical Medicine Rehabilitation Training and Research Hospital

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Patients will be blind to treatment
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Model Details: Whole Body Vibration (WBV) will be applied to Poststroke Hemiplegia. The patients are divided in two groups; WBV group and shame WBV group.

Study Record Dates

• First Submitted: April 11, 2019
• First Posted: April 16, 2019
• Study Start: August 1, 2019
• Primary Completion: March 1, 2020
• Study Completion: August 1, 2020
• Last Updated: January 13, 2022

Record last verified: 2021-12

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)