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Muscle SpasticityWBVNCT03916770

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

A study testing Real vibrator in people with Muscle Spasticity and Physiology, run by Istanbul Physical Medicine Rehabilitation Training and Research Hospital at 1 site in Turkey (Türkiye).

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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… Read more about this study

Who is it for?
Ages 18 to 90 years
Conditions the study is for
Muscle Spasticity, Physiology
What is being tested?
Real vibrator
Type of treatment
Medical device
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
48 participants
Where
1 siteTurkey (Türkiye)
Study dates
1 Aug 2019to 1 Aug 2020
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 90 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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,
Show all 15Show fewer
  • 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

Trial locations and contacts

1 site in 1 country.

Turkey (Türkiye)1 site

  • Istanbul Physical Medicine Rehabilitation Training and Research Hospital Istanbul, Turkey

    Istanbul

Other trials in Turkey (Türkiye)

About this study

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

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.
Read the 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

Being tested
Sham vibrator, Real vibrator
Keywords
muscle, vibration, H reflex, H/M ratio, spasticity
Medical subject headings
Muscle Spasticity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Sham vibratorDevice

    Also called Sham WBV

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

  • Real vibratorDevice

    Also called Real WBV

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

Study groups in NCT03916770
Study groupRoleWhat they receive
whole body vibrationActive comparatorWBV(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)
Receives: Device: Real vibrator
Sham whole body vibrationSham comparatorThe 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 ).
Receives: Device: Sham vibrator

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. spasticity-torque

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

    Measured: 4 weeks

  2. spasiticity-modified Ashworth scale

    The spasticity degree of the plantar flexors will be evaluated by using a subjective assessment method (modified Ashworth scale-MAS)

    Measured: 4 weeks

  3. 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

    Measured: 4 weeks

  4. 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

    Measured: 4 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted16 Apr 2019
  2. Study start1 Aug 2019
  3. Primary completion1 Mar 2020
  4. Study completion1 Aug 2020

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
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.
Masking
Single blind
Who is masked
Participant
Enrolment
48 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03916770
Sponsor's protocol ID
IstPMRTRH-BMR
Acronym
WBV
Status last verified
Dec 2021
First submitted
11 Apr 2019
Last updated
13 Jan 2022
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 23035004

  • 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.

    PubMed 23486302

  • 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.

    PubMed 29032720

  • 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.

    PubMed 22289234

  • 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.

    PubMed 30225145

Questions about this trial

What is this clinical trial studying?

A study testing Real vibrator in people with Muscle Spasticity and Physiology, run by Istanbul Physical Medicine Rehabilitation Training and Research Hospital at 1 site in Turkey (Türkiye).

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 13 Jan 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

spasticity-torque (time frame: 4 weeks). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03916770, which also lists 5 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jan 2022.

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