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

NCT03419793 | Completed

• 1 other identifier: 212/17
• Study Type: interventional
• Target: 37
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Stroke

Outcome Measures

Primary Outcomes (1)

• 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.

  Change from Baseline Range of Motion at 8 weeks

Secondary Outcomes (3)

• Barthel Index (BI)

  Change from Baseline Functional level at 8 weeks

• Manual Muscle Testing (MMT)

  Change from Baseline Muscle power at 8 weeks

• Modified Ashworth Scale (MAS)

  Change from Baseline muscle tone at 8 weeks

Study Arms (2)

physical therapy intervention and segmental muscle vibration

EXPERIMENTAL

physiotherapy intervention and segmental muscle vibration device

Device: segmental vibration device; Other: physical therapy exercises

physical therapy intervention

SHAM COMPARATOR

physical therapy intervention alone

Other: physical therapy exercises

Interventions

segmental vibration device DEVICE

segmental vibration device

Also known as: physical therapy intervention

physical therapy intervention and segmental muscle vibration

physical therapy exercises OTHER

Also known as: manual resistance exercise

physical therapy intervention; physical therapy intervention and segmental muscle vibration

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• confirmed diagnosis of stroke

You may not qualify if:

• if they had any serious orthopedic injury/disease, cardiopulmonary problems or suffered from a neurological disease (other than stroke).

Sponsors & Collaborators

• University of Rome Tor Vergata: lead

MeSH Terms

Conditions

Stroke

Interventions

Exercise Therapy

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Therapeutics; Physical Therapy Modalities

Study Officials

• Giuseppe Annino, PhD

  department of medicine systems

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: January 18, 2018
• First Posted: February 5, 2018
• Study Start: July 1, 2016
• Primary Completion: September 1, 2016
• Study Completion: January 1, 2018
• Last Updated: February 5, 2018

Record last verified: 2018-01