Focal Muscular Vibration to Treat Upper Limb Spasticity in Stroke

Stroke Clinical Trial

Official title:

Efficacy of Focal Muscular Vibration in the Treatment of Upper Limb Spasticity in Subjects With Stroke Outcomes: Randomized Controlled Trial.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04087928
• Other study ID #: FMV_2019
• Status: Completed
• Phase: N/A
• Start date: September 16, 2019
• Est. completion date: December 20, 2019

Study information

• Verified date: February 2020
• Source: Fondazione Don Carlo Gnocchi Onlus
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 28
• Est. completion date: December 20, 2019
• Est. primary completion date: December 20, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 35 Years to 80 Years

Eligibility

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).

Related Conditions & MeSH terms

• Stroke

Intervention

Device:
• FMV_flex
Fisiocomputer EVM (Endomedica, Italy) for application of FMV to flexor muscles of the upper limb (brachial biceps and carpal flexors).
• FMV_ext
Fisiocomputer EVM (Endomedica, Italy) for application of FMV to extensors muscles of the upper limb (triceps brachial and carpus extensors).

Locations

Country	Name	City	State
Italy	Irene Aprile	Roma

Sponsors (1)

Lead Sponsor	Collaborator
Fondazione Don Carlo Gnocchi Onlus

Country where clinical trial is conducted

Italy, 

References & Publications (8)

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.

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/s004 — View 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 Reh — View Citation

Hagbarth KE, Eklund G. Tonic vibration reflexes (TVR) in spasticity. Brain Res. 1966 Aug;2(2):201-3. — View 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. — View 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. Review. — View 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):325-3 — View 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 spastici — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Reaching movements	Reaching movements are evaluated by the robot Motore (Humanware).	Baseline (T0), Treatment (1 weeks) (T1), Follow up (4 weeks ) (T2)
Other	Tone of the fingers	Assessment of the finger tone, measured in Newton (N), is obtained through Amadeo (Tyromotion).	Baseline (T0), Treatment (1 weeks) (T1), Follow up (4 weeks ) (T2)
Other	Strength of the fingers	Assessment of the finger strength, measured in Newton (N), is obtained through Amadeo (Tyromotion).	Baseline (T0), Treatment (1 weeks) (T1), Follow up (4 weeks ) (T2)
Primary	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	Change in Motricity Index (MI)	The MI aims to evaluate lower limb motor impairment after stroke, administrated on both sides.; Items to assess the lower limbs are 3, scoring from 0 to 33 each: (1) ankle dorsiflexion with foot in a plantar flexedposition (2) knee extension with the foot unsupported and the knee at 90° (3) hip flexion with the hip at 90° moving the knee as close as possible to the chin. (no movement: 0, palpable flicker but no movement: 9, movement but not against gravity :14, movement against gravity movement against gravity: 19, movement against resistance: 25, normal:33).	Baseline (T0), Treatment (1 weeks) (T1), Follow up (4 weeks ) (T2)
Secondary	Change in ID Pain	The ID Pain questionnaire (ID-P) is used to evaluate presence of neuropathic pain. Is a tool composed of a six dichotomous answer questions (yes/no). The total score is calculated by assigning a point for each 'yes' to question 1-5 and no points for every 'no'. Instead, a point is subtracted for 'yes' to question 6 and no points are assigned for 'no'. A score equal to greater than '3' indicates a presence of neuropathic pain.	Baseline (T0), Treatment (1 weeks) (T1), Follow up (4 weeks ) (T2)
Secondary	Change in Neuropathic Pain four Questions (DN4)	The DN4 used to evaluate presence of neuropathic pain, and consist of a brief interview of four questions answered yes/no: two on what the patient has conceived and two during the exam for the evaluation of hypoesthesia to the touch or sting and the evaluation of allodynia with the skimming of the skin. For each 'yes' a point is assigned. The total score is given by the sum of the individuals. The cut off for the presence of neuropathic pain is '4'.	Baseline (T0), Treatment (1 weeks) (T1), Follow up (4 weeks ) (T2)
Secondary	Change in Neuropathic Pain Symptom Inventory (NPSI)	The NPSI consist of ten descriptors of neuropathic pain plus two elements for the duration of spontaneous and paroxysmal pains. The tool evaluates mean pain intensity in the last 24h in a verbal numeric scale from zero (no pain) to 10 (worst imaginable pain). Total pain intensity score may be calculated by the sum of 10 descriptors.	Baseline (T0), Treatment (1 weeks) (T1), Follow up (4 weeks ) (T2)
Secondary	Change in Numerical Rating Scale (NRS)	The NRS is a quantitative one-dimensional numerical scale of pain assessment at 11 points; the scale requires the operator to ask the patient to select the number that best describes the intensity of hi s pain, from 0 to 10, at that precise moment.	Baseline (T0), Treatment (1 weeks) (T1), Follow up (4 weeks ) (T2)