search
Back to results

Effect of Segmental Muscle Vibration on Upper Extremity Functional Ability Post Stroke

Primary Purpose

Stroke

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
segmental vibration device
physical therapy exercises
Sponsored by
University of Rome Tor Vergata
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

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Sham Comparator

    Arm Label

    physical therapy intervention and segmental muscle vibration

    physical therapy intervention

    Arm Description

    physiotherapy intervention and segmental muscle vibration device

    physical therapy intervention alone

    Outcomes

    Primary Outcome Measures

    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.

    Secondary 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
    Manual Muscle Testing (MMT)
    Muscle strength assessed by using manual muscle testing (MMT) . The six- point Medical Research Council (MRC) Scale is the most often used system, with the procedures detecting the magnitude of strength by grading muscle strength from 0 to 5. In which a score of 0 was no contraction, 1 was a flicker of contraction, 2 was active movement with gravity eliminated, 3 was active movement against gravity, 4 was active movement against gravity and resistance and 5 was normal power
    Modified Ashworth Scale (MAS)
    The scale is used to assign a subjective rating of the amount of resistance or tone perceived by the examiner as a limb is moved through its full range of motion. The original Ashworth scale consisted of 5 grades from 0 - 4. in which score of 0 was no increase in muscle tone, 1 was 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+ was slight increase in muscle tone, manifested by a catch, followed by minimal resistance throughout the remainder (less than half) of the ROM, 2 was more marked increase in muscle tone through most of the ROM, but affected part(s) easily moved, 3 was considerable increase in muscle tone, passive movement difficult and 4 was affected part(s) rigid in flexion or extension

    Full Information

    First Posted
    January 18, 2018
    Last Updated
    January 26, 2018
    Sponsor
    University of Rome Tor Vergata
    search

    1. Study Identification

    Unique Protocol Identification Number
    NCT03419793
    Brief Title
    Effect of Segmental Muscle Vibration on Upper Extremity Functional Ability Post Stroke
    Official Title
    Effect of Segmental Muscle Vibration on Upper Extremity Functional Ability Post Stroke
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    January 2018
    Overall Recruitment Status
    Completed
    Study Start Date
    July 2016 (Actual)
    Primary Completion Date
    September 2016 (Actual)
    Study Completion Date
    January 2018 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    University of Rome Tor Vergata

    4. Oversight

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

    5. Study Description

    Brief Summary
    Background and objective: Upper extremity functional impairments are common consequences post stroke. The aim of this study was to investigate the influence of Segmental muscle vibration (SMV) application along with supervised physical therapy (SPT) on improving activities of daily living (ADL) and motor recovery on the hemiparetic upper extremity in patients with stroke. Methods: A sample of 37 patients post stroke (29 males) was randomly assigned to either supervised physical therapy (SPT) control group (n=18) or supervised physical therapy and segmental muscle vibration (SPT-SMV) experimental group (n=19). All patients received 3 sessions per week of SPT for 8 weeks. The SPT-SMV experimental group received SMV at the end of each SPT session. Outcome measures used were Barthel Index (BI), Modified Ashworth Scale (MAS), Manual Muscle Testing (MMT), and goniometry for Range of Motion (ROM) assessment.

    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
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    37 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    physical therapy intervention and segmental muscle vibration
    Arm Type
    Experimental
    Arm Description
    physiotherapy intervention and segmental muscle vibration device
    Arm Title
    physical therapy intervention
    Arm Type
    Sham Comparator
    Arm Description
    physical therapy intervention alone
    Intervention Type
    Device
    Intervention Name(s)
    segmental vibration device
    Other Intervention Name(s)
    physical therapy intervention
    Intervention Description
    segmental vibration device
    Intervention Type
    Other
    Intervention Name(s)
    physical therapy exercises
    Other Intervention Name(s)
    manual resistance exercise
    Primary Outcome Measure Information:
    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
    Secondary 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 Functional level at 8 weeks
    Title
    Manual Muscle Testing (MMT)
    Description
    Muscle strength assessed by using manual muscle testing (MMT) . The six- point Medical Research Council (MRC) Scale is the most often used system, with the procedures detecting the magnitude of strength by grading muscle strength from 0 to 5. In which a score of 0 was no contraction, 1 was a flicker of contraction, 2 was active movement with gravity eliminated, 3 was active movement against gravity, 4 was active movement against gravity and resistance and 5 was normal power
    Time Frame
    Change from Baseline Muscle power at 8 weeks
    Title
    Modified Ashworth Scale (MAS)
    Description
    The scale is used to assign a subjective rating of the amount of resistance or tone perceived by the examiner as a limb is moved through its full range of motion. The original Ashworth scale consisted of 5 grades from 0 - 4. in which score of 0 was no increase in muscle tone, 1 was 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+ was slight increase in muscle tone, manifested by a catch, followed by minimal resistance throughout the remainder (less than half) of the ROM, 2 was more marked increase in muscle tone through most of the ROM, but affected part(s) easily moved, 3 was considerable increase in muscle tone, passive movement difficult and 4 was affected part(s) rigid in flexion or extension
    Time Frame
    Change from Baseline muscle tone 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).
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Giuseppe Annino, PhD
    Organizational Affiliation
    department of medicine systems
    Official's Role
    Study Director

    12. IPD Sharing Statement

    Learn more about this trial

    Effect of Segmental Muscle Vibration on Upper Extremity Functional Ability Post Stroke

    We'll reach out to this number within 24 hrs