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

NCT ID: NCT03419793

Last Updated: 2018-02-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

37 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-07-31

Study Completion Date

2018-01-31

Brief Summary

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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.

Detailed Description

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Conditions

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Stroke

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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physical therapy intervention and segmental muscle vibration

physiotherapy intervention and segmental muscle vibration device

Group Type EXPERIMENTAL

segmental vibration device

Intervention Type DEVICE

segmental vibration device

physical therapy exercises

Intervention Type OTHER

physical therapy intervention

physical therapy intervention alone

Group Type SHAM_COMPARATOR

physical therapy exercises

Intervention Type OTHER

Interventions

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segmental vibration device

segmental vibration device

Intervention Type DEVICE

physical therapy exercises

Intervention Type OTHER

Other Intervention Names

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physical therapy intervention manual resistance exercise

Eligibility Criteria

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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).
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Rome Tor Vergata

OTHER

Sponsor Role lead

Responsible Party

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Giuseppe Annino

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Giuseppe Annino, PhD

Role: STUDY_DIRECTOR

department of medicine systems

Other Identifiers

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212/17

Identifier Type: -

Identifier Source: org_study_id

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