Focal Muscle Vibration on Upper Limb Function in Subacute Post-stroke Patients

NCT04289766 | Completed DMC

• 1 other identifier: REC/00654 Irum Farooq
• Study Type: interventional
• Target: 106
• Locations: 1 country
• Sites: 1

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.

Conditions

Stroke, Subacute

Outcome Measures

Primary Outcomes (3)

• Fugl Meyer Scale (FMS)

  Changes from the Baseline this scale was measured Fugl Meyer Assessment is the utmost extensively used and approved clinical scale for assessment of sensorimotor loss in post stroke patients.This scale is comprised of five domains and there are 155 items in total: * Motor functioning (in the upper and lower extremities) * Sensory functioning (evaluates light touch on two surfaces of the arm and leg, and position sense for 8 joints) * Balance (contains 7 tests, 3 seated and 4 standing) * Joint range of motion (8 joints) * Joint pain 3-point ordinal scale where 0=cannot perform, 1=performs partially and 2=performs fully. The total possible scale score is 226. MAS detecting the changes in muscle tone in patients with stroke.. It's a 6 point scale. 0=no muscle tone, 4= affected parts rigid flexion or extension.Its reliability is 0.567.

  Change from Baseline to 8 Weeks

• Motor Assessment Scale (MAS)

  Changes from the Baseline this scale was measured * . The Motor Assessment Scale (MAS) is used to assess everyday motor function in patients with stroke. 8 items assess 8 areas of motor function * Patients perform each task 3 times, only the best performance is recorded * Items (with the exception of the general tonus item\*) are assessed using a 7-point scale (0 to 6) * A score of 6 indicates optimal motor behavior * Item scores (with the exception of the general tonus item) are summed to provide an overall score (out of 48 points) * Completing a higher-level item suggests successful performance on lower-level items and thus lower-items can be skipped. For the general tonus item, the score is based on continuous observations throughout the assessment. A score of 4 on this item indicates a consistently normal response, a score \> 4 indicates persistent hyper-tonus, and a score \< 4 indicates various degrees of hypo-tonus

  Change from Baseline to 8 Weeks

• Modified Ashworth Scale

  Changes from the Baseline this scale was measured * Modified Ashworth Scale' scores exhibited better reliability when measuring upper extremities than lower\[11\]. The scale is as below: * 0 No increase in muscle tone * 1 Slight increase in muscle tone, manifested by a catch and release or by minimal resistance at the end of the range of motion when the affected part(s) is moved in flexion or extension * 1+ Slight increase in muscle tone, manifested by a catch, followed by minimal resistance throughout the remainder (less than half) of the ROM * 2 More marked increase in muscle tone through most of the ROM, but affected part(s) easily moved * 3 Considerable increase in muscle tone, passive movement difficult * 4 Affected part(s) rigid in flexion or extension

  Change from Baseline to 8 Weeks

Study Arms (3)

Conventional Treatment

ACTIVE COMPARATOR

Conventional Treatment includes exercises limbs

Other: Conventional Treatment

Focal Muscle Vibration (120Hz)

EXPERIMENTAL

* Each session will span 40 minutes plus 10 of Focal Muscle vibration for each muscle at a frequency of 120 Hz. * Conventional Treatment

Other: Focal Muscle Vibration (120Hz)

Focal Muscle Vibration (60Hz)

EXPERIMENTAL

* Each session will span 40 minutes plus 10 of Focal Muscle vibration for each muscle at a frequency of 60 Hz. * Conventional Treatment

Other: Focal Muscle Vibration (60Hz)

Interventions

Conventional Treatment OTHER

These individuals will receive the conventional intervention including the routine rehabilitation therapy like active and passive ROMs, stretching, strengthening of upper limb, balance improvement exercises. Time duration is of 40 minute 3 times per week.

Conventional Treatment

Focal Muscle Vibration (120Hz) OTHER

These individuals will receive conventional therapy along with Focal Muscle Vibration applied to the hyper toned muscles (Bicep Brachialis and Extensor Carpi Radialis). Evaluation at baseline and after the end session (Total 24 session). i.e. 3 sessions/week for 8 weeks.

Focal Muscle Vibration (120Hz)

Focal Muscle Vibration (60Hz) OTHER

These individuals will receive conventional therapy along with Focal Muscle Vibration applied to the hyper toned muscles (Bicep Brachialis and Extensor Carpi Radialis). Evaluation at baseline and after the end session (Total 24 session). i.e. 3 sessions/week for 8 weeks.

Focal Muscle Vibration (60Hz)

Eligibility Criteria

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

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Riphah International University: lead

Study Sites (1)

Railway General Hospital

Rawalpindi, Punjab Province, 44000, Pakistan

Location

Related Publications (5)

• 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.

  PMID: 30762754 BACKGROUND

• 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.

  PMID: 19855076 BACKGROUND

• 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.

  PMID: 16680616 BACKGROUND

• 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.

  PMID: 25227540 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

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

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

Study Officials

• Imran Amjad, Phd

  Riphah International University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 27, 2020
• First Posted: February 28, 2020
• Study Start: February 26, 2020
• Primary Completion: April 20, 2021
• Study Completion: April 20, 2021
• Last Updated: April 21, 2021

Record last verified: 2021-04

Data Sharing

• IPD Sharing: Will not share

Locations

PA (1)