Clinical trial NCT04289766: Focal Muscle Vibration on Upper Limb Function in Subacute Post-stroke Patients
Official title: Effects of Focal Muscle Vibration on Upper Limb Function in Subacute Post-stroke Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Stroke, Subacute
Lead sponsor: Riphah International University
Sponsor class: OTHER
First posted: 2020-02-28
Enrollment: 106
Sex: ALL
Minimum age (years): 35
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Stroke is the second leading cause of death, accounting for 11.13 % of total deaths, and the main cause of disability worldwide. The major type of stroke is ischemic, which occurs in about 87% of all stroke cases Stroke has different risk factors, which can be grouped into modifiable and non-modifiable risk factors. Major risk factors for stroke include age, history of cerebrovascular event, smoking, alcohol consumption, physical inactivity, hypertension, diabetes mellitus, cardiovascular diseases, obesity, metabolic syndrome, diet, nutrition, and genetic risk factors. Many new technique used for rehabilitation after stroke includes Constraint-Induced Movement Therapy for Arm or Leg Paralysis, Mirror Therapy for Hand Recovery, Harness the Relentless Force etc. Segmental muscle vibration (SMV) is also a new technique and effective to decrease the hyper-toned muscles spasticity but still less work done on it. SMV with different frequencies have different effects for both flaccid and spastic patients of all 3 stages of stroke. In our study we will work with 60hz and 120hz frequencies to reduce the spasticity of upper limb and improves their functional level.

Detailed description: Evidence strongly suggest that a period of pure sensory stimulation can affect motor corticoids activity excitability.

In 2019 segmental muscle vibration(SMV) used to improve upper extremity functional ability post stroke and concluded that patients in both groups improved significantly after treatment in Barthel index (BI), elbow Range of Motion (ROM) and elbow muscle strength. However muscle tone in elbow joint of hemiplegic upper extremity improved significantly after only in the experimental group. They suggested that with routine physiotherapy with extended exposure SMV will results in significant reduced spasticity and better improved Activities Of Daily Livings (ADLs).

In 2019 a work done with SMV to improve gate performance in patients with foot drop after chronic stroke. Results of this study revealed moderate improvement in mean gate speed, normal side swing velocity, bilateral stride length and normal-side toe off in experimental group. Further studies needed to evaluate the optimal and minimum SMV dosage.

Another study conducted in 2019 to see Results show that processing speed, inhibitory control and attention improved following SMV. But working memory between groups and also not show a association between executive functions course and fall risk, so they suggest further work to examine effects of vibration therapy on executive functions.

In 2014 another therapist highlight the potential use of SMV to modulate electromyographic (EMG) for reaching movement in chronic stroke patients but needs to be confirmed by larger control perspective trials of SMV.

In 2019 combined work done with repetitive focal muscle vibration with physiotherapy to improve the motor function even in very acute phase of stroke and finds it a valid complementary non pharmacological therapy In 2019 another study suggest that Whole Body Vibration (WBV) and Upper and Lower Cycle (ULC) effective upper for upper extremity motor function and grip strength in sub-acute stroke.

In 2019 a study reported the risk factors (vibration injury to hands vascular components, intermediate blanching neurological components and lower back pain for drivers of work machines) and benefits (improvement in bone health and neuromuscular function). So is a room for research to design a balanced WBV protocol.

A study in 2018 did a meta-analysis and compare the effects of WBV in stroke patients and concludes that it is a safe therapeutic method for improving symptoms.

Eligibility criteria: Inclusion Criteria:

* Hemiplegic affected side spastic \<3 on the Ashworth scale.
* History of stroke should be \> 6 weeks and \<12 weeks.

Exclusion Criteria:

* Individuals with the other neurological deficit
* Diabetic ulcer, infection or amputation of limb
* Serious cardiovascular disease or unstable angina
* Serious orthopedic problem
* Chronic medical problems

Primary outcomes:
measure: Fugl Meyer Scale (FMS)
timeFrame: Change from Baseline to 8 Weeks
measure: Motor Assessment Scale (MAS)
timeFrame: Change from Baseline to 8 Weeks
measure: Modified Ashworth Scale
timeFrame: Change from Baseline to 8 Weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Rawalpindi
country: Pakistan
facility: Railway General Hospital
state: Punjab
Study officials:
affiliation: Riphah International University
name: Imran Amjad, Phd
role: PRINCIPAL_INVESTIGATOR
References:
citation: Annino G, Alashram AR, Alghwiri AA, Romagnoli C, Messina G, Tancredi V, Padua E, Mercuri NB. Effect of segmental muscle vibration on upper extremity functional ability poststroke: A randomized controlled trial. Medicine (Baltimore). 2019 Feb;98(7):e14444. doi: 10.1097/MD.0000000000014444.
citation: Paoloni M, Mangone M, Scettri P, Procaccianti R, Cometa A, Santilli V. Segmental muscle vibration improves walking in chronic stroke patients with foot drop: a randomized controlled trial. Neurorehabil Neural Repair. 2010 Mar-Apr;24(3):254-62. doi: 10.1177/1545968309349940. Epub 2009 Oct 23.
citation: Smith L, Brouwer B. Effectiveness of muscle vibration in modulating corticospinal excitability. J Rehabil Res Dev. 2005 Nov-Dec;42(6):787-94. doi: 10.1682/jrrd.2005.02.0041.
citation: Paoloni M, Tavernese E, Fini M, Sale P, Franceschini M, Santilli V, Mangone M. Segmental muscle vibration modifies muscle activation during reaching in chronic stroke: A pilot study. NeuroRehabilitation. 2014;35(3):405-14. doi: 10.3233/NRE-141131.
citation: 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.