Localized Muscle Vibration Post Stroke

NCT04700553 | Unknown DMC

• 1 other identifier: 187/20
• Study Type: interventional
• Target: 35
• Locations: 1 country
• Sites: 1

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.

Conditions

Stroke

Outcome Measures

Primary Outcomes (1)

• 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

  Change from baseline activity of daily livings at 8 weeks

Secondary Outcomes (4)

• Berg Balance Scale

  Change from baseline balance at 8 weeks

• Goniometry

  Change from baseline range of motion at 8 weeks

• Manual Muscle Testing

  Change from baseline range of motion at 8 weeks

• Modified Ashworth Scale

  Change from baseline range of motion at 8 weeks

Study Arms (2)

Conventional physical therapy intervention plus localized muscle vibration

EXPERIMENTAL

physical therapy intervention plus localized muscle vibration

Device: Localized muscle vibration; Other: Conventional physiotherapy intervention

Conventional physical therapy intervention

SHAM COMPARATOR

physical therapy intervention

Other: Conventional physiotherapy intervention

Interventions

Localized muscle vibration DEVICE

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.

Also known as: manual resistance exercise, treadmill training

Conventional physical therapy intervention plus localized muscle vibration

Conventional physiotherapy intervention OTHER

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.

Also known as: manual resistance exercise, treadmill training

Conventional physical therapy intervention; Conventional physical therapy intervention plus localized 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

• Giuseppe Annino: lead

Study Sites (1)

Policlinico Tor Vergata

Rome, RM, 00133, Italy

Location

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

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

Study Officials

• Giuseppe Annino, PhD

  University of Rome Tor Vergata

  STUDY DIRECTOR

Central Study Contacts

Anas R Alashram, PhD

CONTACT

00962770376817; anasalashram@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: January 1, 2021
• First Posted: January 8, 2021
• Study Start: July 1, 2023
• Primary Completion: August 31, 2023
• Study Completion: August 31, 2023
• Last Updated: June 13, 2023

Record last verified: 2023-06

Locations

IT (1)