Localized Muscle Vibration Post Stroke

• ClinicalTrials.gov Identifier: NCT04700553
• Recruitment Status: Completed
• First Posted: January 8, 2021
• Last Update Posted: February 16, 2021
• Sponsor: Giuseppe Annino
• Information provided by (Responsible Party): Giuseppe Annino, University of Rome Tor Vergata

Study Description

Brief Summary:

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.

Condition or disease	Intervention/treatment	Phase
Stroke	Device: Localized muscle vibration; Other: Conventional physiotherapy intervention	Not Applicable

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 Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 37 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: Efficacy of Localized Muscle Vibration on Lower Extremity Functional Ability in Patients With Stroke: A Randomized Controlled Trial
• Actual Study Start Date: November 1, 2020
• Actual Primary Completion Date: December 31, 2020
• Actual Study Completion Date: December 31, 2020

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures :

1. Barthel Index (BI) [ Time Frame: Change from baseline activity of daily livings at 8 weeks ]
   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

Secondary Outcome Measures :

1. Berg Balance Scale [ Time Frame: Change from baseline balance at 8 weeks ]
   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.
2. Goniometry [ Time Frame: Change from baseline range of motion at 8 weeks ]
   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.
3. Manual Muscle Testing [ Time Frame: Change from baseline range of motion at 8 weeks ]
   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.
4. Modified Ashworth Scale [ Time Frame: Change from baseline range of motion at 8 weeks ]
   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.

Eligibility Criteria

• Ages Eligible for Study: Child, Adult, Older Adult
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

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).

Contacts and Locations

Locations

Italy

Policlinico Tor Vergata

Rome, RM, Italy, 00133

Sponsors and Collaborators

Giuseppe Annino

Investigators

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

More Information

• Responsible Party: Giuseppe Annino, Professor, University of Rome Tor Vergata
• ClinicalTrials.gov Identifier: NCT04700553
• Other Study ID Numbers: 187/20
• First Posted: January 8, 2021
• Last Update Posted: February 16, 2021
• Last Verified: February 2021

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:

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