Focal Muscular Vibration to Treat Upper Limb Spasticity in Stroke

NCT04087928 | Completed

• 1 other identifier: FMV_2019
• Study Type: interventional
• Target: 28
• Locations: 1 country
• Sites: 1

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.

Conditions

Stroke

Keywords

Stroke; Upper limb; Rehabilitation; Focal Muscular Vibration

Outcome Measures

Primary Outcomes (1)

• Change in Modified Ashworth Scale (MAS)

  The MAS is a 6 point ordinal scale used for grading hypertonia in individuals with neurological diagnoses. A score of 0 on the scale indicates no increase in tone while a score of 4 indicates rigidity. Tone is scored by passively moving the individual's limb and assessing the amount of resistance to movement felt by the examiner.

  Baseline (T0), Treatment (1 weeks) (T1), Follow up (4 weeks ) (T2)

Secondary Outcomes (5)

• Change in Motricity Index (MI)

  Baseline (T0), Treatment (1 weeks) (T1), Follow up (4 weeks ) (T2)

• Change in ID Pain

  Baseline (T0), Treatment (1 weeks) (T1), Follow up (4 weeks ) (T2)

• Change in Neuropathic Pain four Questions (DN4)

  Baseline (T0), Treatment (1 weeks) (T1), Follow up (4 weeks ) (T2)

• Change in Neuropathic Pain Symptom Inventory (NPSI)

  Baseline (T0), Treatment (1 weeks) (T1), Follow up (4 weeks ) (T2)

• Change in Numerical Rating Scale (NRS)

  Baseline (T0), Treatment (1 weeks) (T1), Follow up (4 weeks ) (T2)

Other Outcomes (3)

• Reaching movements

  Baseline (T0), Treatment (1 weeks) (T1), Follow up (4 weeks ) (T2)

• Tone of the fingers

  Baseline (T0), Treatment (1 weeks) (T1), Follow up (4 weeks ) (T2)

• Strength of the fingers

  Baseline (T0), Treatment (1 weeks) (T1), Follow up (4 weeks ) (T2)

Study Arms (2)

Group Flexors (A)

EXPERIMENTAL

Group A was treated by applying FMV to the flexor muscles of the upper limb (brachial biceps and carpal flexors). Patients will be treated with FMV for three consecutive days: each session consisted of three sessions of 10 minutes each, interspersed with one minute of rest. A vibration frequency of 100 Hz has been applied, according to the literature.

Device: FMV_flex

Group Extensors (B)

EXPERIMENTAL

Group b was treated by applying FMV to the extensors muscles of the upper limb (triceps brachial and carpus extensors). Patients will be treated with FMV for three consecutive days: each session consisted of three sessions of 10 minutes each, interspersed with one minute of rest. A vibration frequency of 100 Hz has been applied, according to the literature.

Device: FMV_ext

Interventions

FMV_flex DEVICE

Fisiocomputer EVM (Endomedica, Italy) for application of FMV to flexor muscles of the upper limb (brachial biceps and carpal flexors).

Group Flexors (A)

FMV_ext DEVICE

Fisiocomputer EVM (Endomedica, Italy) for application of FMV to extensors muscles of the upper limb (triceps brachial and carpus extensors).

Group Extensors (B)

Eligibility Criteria

• Age: 35 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• first cerebral stroke
• 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

You may not qualify if:

• 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).

Sponsors & Collaborators

• Fondazione Don Carlo Gnocchi Onlus: lead

Study Sites (1)

Irene Aprile

Roma, 00166, Italy

Location

Related Publications (8)

• 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.

  PMID: 24842220 RESULT

• 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.

  PMID: 5968925 RESULT

• 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.

  RESULT

• 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.

  PMID: 21209488 RESULT

• 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.

  PMID: 22402727 RESULT

• 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.

  PMID: 22507444 RESULT

• 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.

  PMID: 20515600 RESULT

• 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.

  PMID: 26818756 RESULT

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Irene Aprile, MD, PhD

  IRCCS Fondazione Don Carlo Gnocchi

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, PhD

Study Record Dates

• First Submitted: September 11, 2019
• First Posted: September 12, 2019
• Study Start: September 16, 2019
• Primary Completion: December 20, 2019
• Study Completion: December 20, 2019
• Last Updated: February 6, 2020

Record last verified: 2020-02

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)