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

About this trial
This is an interventional treatment trial for Stroke
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).
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
NCT ID
NCT03419793
First Posted
January 18, 2018
Last Updated
January 26, 2018
Sponsor
University of Rome Tor Vergata
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
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Effect of Segmental Muscle Vibration on Upper Extremity Functional Ability Post Stroke
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