Localized Muscle Vibration Post Stroke

Efficacy of Localized Muscle Vibration on Lower Extremity Functional Ability in Patients With Stroke: A Randomized Controlled Trial

Background and objectives: Lower extremity functional impairments are common consequences of stroke. Thus, continuous examination of effective treatment interventions for lower extremity functions after stroke is a necessity. Localized muscle vibration (LMV) is one of the treatment interventions that incorporate sensory stimulation to improve motor cortical excitability. This study aimed to investigate the influences of 10-minutes lower extremity LMV application along with conventional physical therapy (CPT) on activities of daily living (ADL) and motor recovery on the hemiparetic lower extremity post-stroke.

Methods: A sample of 37 patients with stroke (8 females) was randomly allocated to either conventional physical therapy (CPT) control group (n=18) or conventional physical therapy and localized muscle vibration (CPT+LMV) experimental group (n=19). All patients received 3 sessions per week of CPT for 8 weeks. The CPT+LMV experimental group received 10-minute LMV at the end of each CPT session. The outcome measures used were the Barthel Index (BI), Berg Balance Scale (BBS), and goniometry for Range of Motion (ROM) assessment.

Study Overview

• Status: Not yet recruiting
• Conditions: Stroke
• Intervention / Treatment: Device: Localized muscle vibration; Other: Conventional physiotherapy intervention

Detailed Description

All patients in both experimental and control groups received CPT protocol consisted of 30 minutes of manual resistance exercise (3 sets/10 repetitions each for knee extensors and flexors) and 30 minutes of treadmill training, short breaks (1-5 minutes) were allowed, depending on the patient tolerance. The training was conducted for 3 days per week for 8 weeks. The patients in CPT+LMV experimental group received localized muscle vibration at the end of each CPT session. The LMV was applied for 10 minutes perpendicularly along quadriceps muscle fibers. The frequency set at 30 Hz, amplitude of 2 mm.

• Study Type: Interventional
• Enrollment (Estimated): 35
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Anas R Alashram, PhD; Phone Number: 00962770376817; Email: anasalashram@gmail.com

Study Locations

• Italy
  • RM
    • Rome, RM, Italy, 00133
      • Policlinico Tor Vergata

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

Confirmed diagnosis of stroke

Exclusion Criteria:

If they had any serious orthopedic injury/disease, cardiopulmonary problems or suffered from a neurological disease (other than stroke).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Conventional physical therapy intervention plus localized muscle vibration; physical therapy intervention plus localized muscle vibration	Device: Localized muscle vibration; All patients in both experimental and control groups received CPT protocol consisted of 30 minutes of manual resistance exercise (3 sets/10 repetitions each for knee extensors and flexors) and 30 minutes of treadmill training, short breaks (1-5 minutes) were allowed, depending on the patient tolerance. The training was conducted for 3 days per week for 8 weeks. The patients in CPT+LMV experimental group received localized muscle vibration at the end of each CPT session. The LMV was applied for 5 minutes perpendicularly along quadriceps muscle fibers. The frequency set at 30 Hz, amplitude of 2 mm.; Other Names: manual resistance exercise; treadmill training; Other: Conventional physiotherapy intervention; All patients in both experimental and control groups received CPT protocol consisted of 30 minutes of manual resistance exercise (3 sets/10 repetitions each for knee extensors and flexors) and 30 minutes of treadmill training, short breaks (1-5 minutes) were allowed, depending on the patient tolerance. The training was conducted for 3 days per week for 8 weeks. The patients in CPT+LMV experimental group received localized muscle vibration at the end of each CPT session. The LMV was applied for 5 minutes perpendicularly along quadriceps muscle fibers. The frequency set at 30 Hz, amplitude of 2 mm.; Other Names: manual resistance exercise; treadmill training
Sham Comparator: Conventional physical therapy intervention; physical therapy intervention	Other: Conventional physiotherapy intervention; All patients in both experimental and control groups received CPT protocol consisted of 30 minutes of manual resistance exercise (3 sets/10 repetitions each for knee extensors and flexors) and 30 minutes of treadmill training, short breaks (1-5 minutes) were allowed, depending on the patient tolerance. The training was conducted for 3 days per week for 8 weeks. The patients in CPT+LMV experimental group received localized muscle vibration at the end of each CPT session. The LMV was applied for 5 minutes perpendicularly along quadriceps muscle fibers. The frequency set at 30 Hz, amplitude of 2 mm.; Other Names: manual resistance exercise; treadmill training

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Barthel Index (BI)	The Barthel Index of Activities of Daily Living (BI). Measure of functional disability. The BI consisting of 10 common activities of daily living (ADL) activities, administered through direct observation. These are assessed for independence/ dependence and scored via an arbitrary weighting system (originally applied to reflect nursing care and social acceptability). Eight of the ten items represent activities related to personal care; the remaining 2 are related to mobility. The index yields a total score out of 100 - the higher the score, the greater the degree of functional independence	Change from baseline activity of daily livings at 8 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Berg Balance Scale	The BBS provides a quantitative measure of balance. This scale consists of 14 items requiring patients to maintain their positions or complete tasks of varying levels of difficulty. All items are related to everyday life tasks. A score of zero represents an inability of the patient to complete the task and a score of 4 represents the ability of the patient to complete the task independently. The total scores range from 0 - 56. A total score of less than 45 indicates a balance impairment.	Change from baseline balance at 8 weeks
Goniometry	Range of motion assessed by goniometry; is the measurement of angles, particularly those formed by joints. These angles may be measured in a standing position or in flexion or extension.	Change from baseline range of motion at 8 weeks
Manual Muscle Testing	The MMT was used to assess muscle strength. The MMT consists of 6 grades. Grade 0 indicates no evidence of contractility (complete paralysis), and 5 indicates movement against gravity plus full resistance.	Change from baseline range of motion at 8 weeks
Modified Ashworth Scale	The MAS was utilized to measure spasticity. The scale asses the resistance of limb to a rapid passive stretch in 6 scores from 0 to 5. Score 0 indicates normal muscle tone, and 5 indicates rigid limb.	Change from baseline range of motion at 8 weeks

Collaborators and Investigators

• Sponsor: Giuseppe Annino
• Investigators: Study Director: Giuseppe Annino, PhD, University of Rome Tor Vergata

Study record dates

Study Major Dates

• Study Start (Estimated): July 1, 2023
• Primary Completion (Estimated): August 31, 2023
• Study Completion (Estimated): August 31, 2023

Study Registration Dates

• First Submitted: January 1, 2021
• First Submitted That Met QC Criteria: January 6, 2021
• First Posted (Actual): January 8, 2021

Study Record Updates

• Last Update Posted (Estimated): June 13, 2023
• Last Update Submitted That Met QC Criteria: June 11, 2023
• Last Verified: June 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Stroke
• Other Study ID Numbers: 187/20

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No