Clinical trial NCT04087928: Focal Muscular Vibration to Treat Upper Limb Spasticity in Stroke
Official title: Efficacy of Focal Muscular Vibration in the Treatment of Upper Limb Spasticity in Subjects With Stroke Outcomes: Randomized Controlled Trial.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Stroke
Keywords: Stroke
Upper limb
Rehabilitation
Focal Muscular Vibration
Lead sponsor: Fondazione Don Carlo Gnocchi Onlus
Sponsor class: OTHER
First posted: 2019-09-12
Enrollment: 28
Sex: ALL
Minimum age (years): 35
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Spasticity following stroke is one of the most debilitating conditions and has a negative influence on the autonomy and quality of life, and greatly worsens the patient's degree of disability. Focal muscular vibration (FMV) is a non-invasive technique to treat spasticity. Has been showed the positive effects of FMV on spasticity in stroke subjects. FMV has been investigated on the antagonist muscle, as well as directly on the spastic muscle, showing in both cases a significant reduction in spasticity. However, isn't unclear which is the most effective in the treatment of spasticity.

The objective of the study is to evaluate the efficacy of FMV of the muscles of the upper limb in subjects with subacute stroke, comparing the effects obtained by treating the spastic muscles directly versus to those obtained by treating the respective antagonist muscles.

Detailed description: Stroke is the major cause of permanent disability with an incidence in Italy of 293 affected persons per 100,000 inhabitants. The onset of spasticity following stroke (20-46%) is one of the most disabling conditions and has a negative influence on the patient's autonomy and quality of life.

The development of spasticity during the rehabilitation process of these patients is a very limiting factor for the functional recovery of the affected side. The onset of spasticity considerably worsens the patient's degree of disability.

Focal muscular vibration (FMV) is a non-invasive technique to treat spasticity. Has been showed the positive effects of FMV on spasticity in stroke subjects.

Introduced by Hagbarth and Eklund at the end of the 1960s, it is based on the tonic-vibratory reflex. Based on this mechanism, some authors suggest that the FMV should be applied to the antagonist muscle in order to obtain a significant reduction in spasticity. However the literature shows a reduction in spasticity through the application of FMV directly on the spastic muscle. These effects seem to be related to the stimulation of cortical motor areas. Nevertheless, it remains unclear which approach is most effective in treating of spasticity.

Stroke is a very common pathology, as well as a rehabilitative and social problem which also affects welfare. Considering prevalence of spasticity in stroke patients and the effects on their functional recovery, it is important to identify the most effective treatment to guarantee a more suitable rehabilitation process. In addition to this, it is worth remembering that FMV is less invasive and has lower costs than botulinum toxin, the current gold standard in the treatment of spasticity.

The objective of the study is to evaluate the efficacy of FMV of the muscles of the upper limb in subjects with subacute stroke, comparing the effects obtained by treating the spastic muscles directly versus to those obtained by treating the respective antagonist muscles. Specifically, the two approaches will be compared on: (i) the reduction of the degree of spasticity, assessed by clinical scales and with an instrumental protocol; (ii) motor performance of the patient, using a robotic system; (iii) pain reduction.

Eligibility criteria: Inclusion Criteria:

* first cerebral stroke
* 2 weeks up to 12 months post the acute event (subacute patients)
* age between 35-80 years
* single cortical or subcortical event
* spastic paresis of the upper limb (Modified Ashworth Scale score ≥ 2)
* ability to give written consent
* compliance with the study procedures

Exclusion Criteria:

* comorbidities affecting the paretic upper limb (fractures, trauma or peripheral neuropathies)
* cognitive and/or communicative disability (e.g. due to brain injury): inability to understand the instructions required for the study
* treatment with focal or systemic antispastic drugs (i.e. baclofen, thiocolchicoside, tizanidine).

Primary outcomes:
measure: Change in Modified Ashworth Scale (MAS)
timeFrame: Baseline (T0), Treatment (1 weeks) (T1), Follow up (4 weeks ) (T2)
Secondary outcomes:
measure: Change in Motricity Index (MI)
timeFrame: Baseline (T0), Treatment (1 weeks) (T1), Follow up (4 weeks ) (T2)
measure: Change in ID Pain
timeFrame: Baseline (T0), Treatment (1 weeks) (T1), Follow up (4 weeks ) (T2)
measure: Change in Neuropathic Pain four Questions (DN4)
timeFrame: Baseline (T0), Treatment (1 weeks) (T1), Follow up (4 weeks ) (T2)
measure: Change in Neuropathic Pain Symptom Inventory (NPSI)
timeFrame: Baseline (T0), Treatment (1 weeks) (T1), Follow up (4 weeks ) (T2)
measure: Change in Numerical Rating Scale (NRS)
timeFrame: Baseline (T0), Treatment (1 weeks) (T1), Follow up (4 weeks ) (T2)
Other outcomes:
measure: Reaching movements
timeFrame: Baseline (T0), Treatment (1 weeks) (T1), Follow up (4 weeks ) (T2)
measure: Tone of the fingers
timeFrame: Baseline (T0), Treatment (1 weeks) (T1), Follow up (4 weeks ) (T2)
measure: Strength of the fingers
timeFrame: Baseline (T0), Treatment (1 weeks) (T1), Follow up (4 weeks ) (T2)
Locations:
city: Roma
country: Italy
facility: Irene Aprile
Study officials:
affiliation: IRCCS Fondazione Don Carlo Gnocchi
name: Irene Aprile, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Murillo N, Valls-Sole J, Vidal J, Opisso E, Medina J, Kumru H. Focal vibration in neurorehabilitation. Eur J Phys Rehabil Med. 2014 Apr;50(2):231-42.
citation: Hagbarth KE, Eklund G. Tonic vibration reflexes (TVR) in spasticity. Brain Res. 1966 Aug;2(2):201-3. doi: 10.1016/0006-8993(66)90029-1. No abstract available.
citation: Ageranoti SA, Hayes KC. Effects of vibration on hypertonia and hyperreflexia in the wrist joint of patients with spastic hemiparesis. Physiotherapy Canada 1990;42:24-33.
citation: Liepert J, Binder C. Vibration-induced effects in stroke patients with spastic hemiparesis--a pilot study. Restor Neurol Neurosci. 2010;28(6):729-35. doi: 10.3233/RNN-2010-0541.
citation: Noma T, Matsumoto S, Shimodozono M, Etoh S, Kawahira K. Anti-spastic effects of the direct application of vibratory stimuli to the spastic muscles of hemiplegic limbs in post-stroke patients: a proof-of-principle study. J Rehabil Med. 2012 Apr;44(4):325-30. doi: 10.2340/16501977-0946.
citation: Caliandro P, Celletti C, Padua L, Minciotti I, Russo G, Granata G, La Torre G, Granieri E, Camerota F. Focal muscle vibration in the treatment of upper limb spasticity: a pilot randomized controlled trial in patients with chronic stroke. Arch Phys Med Rehabil. 2012 Sep;93(9):1656-61. doi: 10.1016/j.apmr.2012.04.002. Epub 2012 Apr 13.
citation: Shaw L, Rodgers H, Price C, van Wijck F, Shackley P, Steen N, Barnes M, Ford G, Graham L; BoTULS investigators. BoTULS: a multicentre randomised controlled trial to evaluate the clinical effectiveness and cost-effectiveness of treating upper limb spasticity due to stroke with botulinum toxin type A. Health Technol Assess. 2010 May;14(26):1-113, iii-iv. doi: 10.3310/hta14260.
citation: Aprile I, Di Sipio E, Germanotta M, Simbolotti C, Padua L. Muscle focal vibration in healthy subjects: evaluation of the effects on upper limb motor performance measured using a robotic device. Eur J Appl Physiol. 2016 Apr;116(4):729-37. doi: 10.1007/s00421-016-3330-1. Epub 2016 Jan 27.