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Localized Muscle Vibration Post Stroke

Primary Purpose

Stroke

Status
Not yet recruiting
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
Localized muscle vibration
Conventional physiotherapy intervention
Sponsored by
Giuseppe Annino
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Stroke

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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).

Sites / Locations

  • Policlinico Tor Vergata

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Sham Comparator

Arm Label

Conventional physical therapy intervention plus localized muscle vibration

Conventional physical therapy intervention

Arm Description

physical therapy intervention plus localized muscle vibration

physical therapy intervention

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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.
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.
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.
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.

Full Information

First Posted
January 1, 2021
Last Updated
June 11, 2023
Sponsor
Giuseppe Annino
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1. Study Identification

Unique Protocol Identification Number
NCT04700553
Brief Title
Localized Muscle Vibration Post Stroke
Official Title
Efficacy of Localized Muscle Vibration on Lower Extremity Functional Ability in Patients With Stroke: A Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
July 1, 2023 (Anticipated)
Primary Completion Date
August 31, 2023 (Anticipated)
Study Completion Date
August 31, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Giuseppe Annino

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
35 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Conventional physical therapy intervention plus localized muscle vibration
Arm Type
Experimental
Arm Description
physical therapy intervention plus localized muscle vibration
Arm Title
Conventional physical therapy intervention
Arm Type
Sham Comparator
Arm Description
physical therapy intervention
Intervention Type
Device
Intervention Name(s)
Localized muscle vibration
Other Intervention Name(s)
manual resistance exercise, treadmill training
Intervention 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 5 minutes perpendicularly along quadriceps muscle fibers. The frequency set at 30 Hz, amplitude of 2 mm.
Intervention Type
Other
Intervention Name(s)
Conventional physiotherapy intervention
Other Intervention Name(s)
manual resistance exercise, treadmill training
Intervention 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 5 minutes perpendicularly along quadriceps muscle fibers. The frequency set at 30 Hz, amplitude of 2 mm.
Primary Outcome Measure Information:
Title
Barthel Index (BI)
Description
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
Time Frame
Change from baseline activity of daily livings at 8 weeks
Secondary Outcome Measure Information:
Title
Berg Balance Scale
Description
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.
Time Frame
Change from baseline balance at 8 weeks
Title
Goniometry
Description
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.
Time Frame
Change from baseline range of motion at 8 weeks
Title
Manual Muscle Testing
Description
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.
Time Frame
Change from baseline range of motion at 8 weeks
Title
Modified Ashworth Scale
Description
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.
Time Frame
Change from baseline range of motion at 8 weeks

10. Eligibility

Sex
All
Accepts Healthy Volunteers
No
Eligibility 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).
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Anas R Alashram, PhD
Phone
00962770376817
Email
anasalashram@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Giuseppe Annino, PhD
Organizational Affiliation
University of Rome Tor Vergata
Official's Role
Study Director
Facility Information:
Facility Name
Policlinico Tor Vergata
City
Rome
State/Province
RM
ZIP/Postal Code
00133
Country
Italy

12. IPD Sharing Statement

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Localized Muscle Vibration Post Stroke

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