Clinical trial NCT04700553: Localized Muscle Vibration Post Stroke
Official title: Efficacy of Localized Muscle Vibration on Lower Extremity Functional Ability in Patients With Stroke: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Stroke
Lead sponsor: University of Rome Tor Vergata
Sponsor class: OTHER
First posted: 2021-01-08
Enrollment: 35
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Detailed description: 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 10 minutes perpendicularly along quadriceps muscle fibers. The frequency set at 30 Hz, amplitude of 2 mm.

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).

Primary outcomes:
measure: Barthel Index (BI)
timeFrame: Change from baseline activity of daily livings at 8 weeks
Secondary outcomes:
measure: Berg Balance Scale
timeFrame: Change from baseline balance at 8 weeks
measure: Goniometry
timeFrame: Change from baseline range of motion at 8 weeks
measure: Manual Muscle Testing
timeFrame: Change from baseline range of motion at 8 weeks
measure: Modified Ashworth Scale
timeFrame: Change from baseline range of motion at 8 weeks
Other outcomes:
Locations:
city: Rome
country: Italy
facility: Policlinico Tor Vergata
state: RM
Study officials:
affiliation: University of Rome Tor Vergata
name: Giuseppe Annino, PhD
role: STUDY_DIRECTOR
References: