Focal Muscle Vibrations in Acute Stroke

NCT06793566 | Withdrawn DMC

• 1 other identifier: CHUO-2024-13
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

A prospective, randomized, double-blind, sham-controlled trial designed to evaluate the effects of Repeated Muscle Vibration (rMV) on motor recovery in acute stroke patients treated within 72 hours of symptom onset

Conditions

Acute Stroke

Keywords

Acute stroke; Repetitive tendinous vibrations; Motor recovery; Non pharmacological therapy; Bedside intervention

Outcome Measures

Primary Outcomes (1)

• Upper limb Fugl Meyer Assessment Score (UL-FMA)

  This is a 66-point scale. A score of 0 corresponds to the maximum deficit and a score of 66 to a normal value.

  Day 4 from start of experiment

Secondary Outcomes (6)

• Upper limb strength

  Day 4 from start of experiment

• Motricity Index (Demeurisse)

  Day 4 from start of experiment

• SAFE Score

  Day 4 from start of experiment

• Total NIHSS

  Day 4 from start of experiment

• muscular mass of the impaired upper limb

  Day 4 from start of experiment

Study Arms (2)

Patients with Vibration

EXPERIMENTAL

VG participants undergo rMV treatment, carried out for three consecutive days by 2 trained physiatrists; each daily session consists of three 10-minute treatment (impaired upper limb), interspersed with a 1-minute break. During the rMV, subjects are required to make a voluntary isometric contraction of the treated muscle

Device: Repeated Muscle Vibration (rMV)

Control group (CG)

SHAM COMPARATOR

Participants in the CG undergo sham rMV, where the vibrator is positioned near the tendon but does not produce vibrations. Sham rMV treatment is carried out for three consecutive days by 2 trained physiatrists; each daily session consists of three 10-minute treatment (impaired upper limb), interspersed with a 1-minute break. During the rMV, subjects are required to make a voluntary isometric contraction of the treated muscle

Device: Repeated Muscle Vibration (rMV)

Interventions

Repeated Muscle Vibration (rMV) DEVICE

rMV treatment, carried out for three consecutive days by 2 trained physiatrists; each daily session consists of three 10-minute treatment (impaired upper limb), interspersed with a 1-minute break. During the rMV, subjects are required to make a voluntary isometric contraction of the treated muscle

Control group (CG); Patients with Vibration

Eligibility Criteria

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

You may qualify if:

• Voluntary patients in the acute phase of a sylvian ischemic stroke (from day 1 to day 7 post-stroke)
• Estimated hospital stay expected to exceed 7 days
• Age ≥ 18 years
• Able to understand and follow evaluation instructions
• Provided informed consent
• Affiliated with a social security scheme
• SAFE score between 4 and 7 on the affected side

You may not qualify if:

• Individuals under guardianship or curatorship
• Individuals deprived of liberty
• Individuals under legal protection (safeguard of justice)
• Other neurological or rheumatological conditions limiting mobility
• Drowsiness (related to stroke or medication)
• Pregnant or breastfeeding women

Sponsors & Collaborators

• Centre Hospitalier Régional d'Orléans: lead

Study Sites (1)

CHU d'ORLEANS

Orléans, 45067, France

Location

Related Publications (10)

• Bertrand AM, Fournier K, Wick Brasey MG, Kaiser ML, Frischknecht R, Diserens K. Reliability of maximal grip strength measurements and grip strength recovery following a stroke. J Hand Ther. 2015 Oct-Dec;28(4):356-62; quiz 363. doi: 10.1016/j.jht.2015.04.004. Epub 2015 May 9.

  PMID: 26206167 BACKGROUND

• Bobos P, Nazari G, Lu Z, MacDermid JC. Measurement Properties of the Hand Grip Strength Assessment: A Systematic Review With Meta-analysis. Arch Phys Med Rehabil. 2020 Mar;101(3):553-565. doi: 10.1016/j.apmr.2019.10.183. Epub 2019 Nov 13.

  PMID: 31730754 BACKGROUND

• 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 BACKGROUND

• Celletti C, Sinibaldi E, Pierelli F, Monari G, Camerota F. Focal Muscle Vibration and Progressive Modular Rebalancing with neurokinetic facilitations in post- stroke recovery of upper limb. Clin Ter. 2017 Jan-Feb;168(1):e33-e36. doi: 10.7417/CT.2017.1979.

  PMID: 28240760 BACKGROUND

• Costantino C, Galuppo L, Romiti D. Short-term effect of local muscle vibration treatment versus sham therapy on upper limb in chronic post-stroke patients: a randomized controlled trial. Eur J Phys Rehabil Med. 2017 Feb;53(1):32-40. doi: 10.23736/S1973-9087.16.04211-8. Epub 2016 Sep 6.

  PMID: 27598342 BACKGROUND

• Demeurisse G, Demol O, Robaye E. Motor evaluation in vascular hemiplegia. Eur Neurol. 1980;19(6):382-9. doi: 10.1159/000115178.

  PMID: 7439211 BACKGROUND

• Fugl-Meyer AR, Jaasko L, Leyman I, Olsson S, Steglind S. The post-stroke hemiplegic patient. 1. a method for evaluation of physical performance. Scand J Rehabil Med. 1975;7(1):13-31.

  PMID: 1135616 BACKGROUND

• Toscano M, Celletti C, Vigano A, Altarocca A, Giuliani G, Jannini TB, Mastria G, Ruggiero M, Maestrini I, Vicenzini E, Altieri M, Camerota F, Di Piero V. Short-Term Effects of Focal Muscle Vibration on Motor Recovery After Acute Stroke: A Pilot Randomized Sham-Controlled Study. Front Neurol. 2019 Feb 19;10:115. doi: 10.3389/fneur.2019.00115. eCollection 2019.

  PMID: 30873102 BACKGROUND

• Abe T, Yoshimura Y, Imai R, Yoneoka Y, Tsubaki A, Sato Y. Impact of Phase Angle on Physical Function in Patients with Acute Stroke. J Stroke Cerebrovasc Dis. 2021 Sep;30(9):105941. doi: 10.1016/j.jstrokecerebrovasdis.2021.105941. Epub 2021 Jun 30.

  PMID: 34217068 BACKGROUND

• Abe T, Yoshimua Y, Imai R, Sato Y. A Combined Assessment Method of Phase Angle and Skeletal Muscle Index to Better Predict Functional Recovery after Acute Stroke. J Nutr Health Aging. 2022;26(5):445-451. doi: 10.1007/s12603-022-1777-9.

  PMID: 35587756 BACKGROUND

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

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

Study Officials

• Canan OZSANCAK, MD

  CHU Orleans

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: Each patient undergoes clinical evaluations at all time points by an experienced investigator blinded to group allocation and distinct from the recruiting personnel. Physical therapists, blinded to treatment allocation, are instructed on the duration, frequency, and content of therapy to ensure consistency across groups.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 21, 2025
• First Posted: January 27, 2025
• Study Start: September 1, 2025
• Primary Completion (Estimated): August 1, 2026
• Study Completion (Estimated): August 1, 2026
• Last Updated: July 10, 2025

Record last verified: 2025-07

Locations

FR (1)