Extracorporeal Shock Wave Therapy and Assessment Strategy Through a Novel Gait Analysis Tool for Post-stroke Spasticity

Efficacy of Extracorporeal Shock Wave Therapy and Assessment Strategy Through a Novel Gait Analysis Tool for Post-stroke Spasticity During COVID-19 Pandemic

The aim of this study is to objectively evaluate the effectiveness of radial extracorporeal shock wave therapy (rESWT) and conventional physical therapy program on the gait pattern through a new gait analysis system which encompasses spatiotemporal and kinematic parameters and to correlate the findings with the clinical evaluation.

Study Overview

• Status: Completed
• Conditions: Spasticity, Muscle; Stroke, Ischemic; Stroke Hemorrhagic; Spastic Gait
• Intervention / Treatment: Other: Radial extracorporeal shock wave therapy and conventional physical therapy

Detailed Description

The aim of this observational study was to objectively evaluate the effects of radial extracorporeal shock wave therapy and conventional physical therapy program on the gait pattern, spatiotemporal variables (step length, step cycle time, stance foot flexion-extension, foot stance pronation-supination, and foot swing flexion-extension), and kinematic parameters (trunk flexion-extension, trunk lateral flexion, hip flexion-extension, knee flexion-extension, ankle flexion-extension) through a new gait analysis system and correlate the findings with clinical outcomes such as Modified Ashworth scale (MAS), passive range of motion (PROM), Clonus score, Visual Analogue Scale (VAS), Tinetti Assessment Tool, Functional Ambulation Categories (FAC).

The gait pattern of post-stroke patients before and after rESWT delivery and conventional rehabilitation program will be assessed clinically and also through an instrumented treadmill (Walker View) in terms of spatiotemporal and kinematic gait parameters.

• Study Type: Observational
• Enrollment (Actual): 15

Contacts and Locations

Study Locations

• Romania
  • Bucharest, Romania
    • Elias University Emergency Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Inpatients from the Physical and Rehabilitation Medicine Department stating the eligibility criteria

Description

Inclusion Criteria:

• suffered from a hemorrhagic or ischemic stroke and they were in the subacute or chronic phase;
• had no history of previous stroke;
• had lower limb post- stroke spasticity and spasticity grade ≥1 on the Modified Ashworth Scale (MAS);
• pain intensity measured on Visual Analogue Scale (VAS) ≥1;
• ability to stand and walk unassisted for at least 30 seconds;
• adult patients (>18 years old).

Exclusion Criteria:

• other neurological, musculoskeletal, orthopaedic, or cardiovascular conditions; -- severe cognitive impairment, severe aphasia or inability to understand or execute instructions;
• changes in antispastic medication and dose or changes in the analgesic medication;
• myopathy;
• severe spasticity grade;
• visual field disorders or hemineglect;
• anticoagulants or any contraindication to receive radial extracorporeal shock wave therapy (rESWT), or any contraindication to receive physical therapy sessions.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

Study group; The patients considered eligible will form the study group and will start the conventional physical therapy program and radial extracorporeal shock wave therapy delivery (rESWT).

Other: Radial extracorporeal shock wave therapy and conventional physical therapy; The conventional physical therapy program will consist of verticalization strategies, range of motion exercises, muscle stretching and strengthening exercises, stance and balance training, core stability exercises, gait training, functional training, cryotherapy or local heat for 1h/day, 5 days/week for 2 weeks. Regarding the rESWT delivery, 2000 shots will be applied on the triceps surae myotendinous junction with a frequency of 10 Hz and an energy density of 60 mJ, 7 min/session, 1 session/week for 2 weeks.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Spasticity grade change	Modified Ashworth Scale (MAS); ranges from 0 (no increase in muscle tone) to 5 (rigid limb in flexion or extension). The lower the score, the lower spasticity grade, thus a better outcome.	Change from baseline Modified Ashworth Scale at 14 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Ankle passive range of motion change	Passive range of motion (PROM); flexion 0-30 degrees, extension 0-50 degrees, pronation 0-30 degrees, supination 0-60 degrees. Higher scores define augmented, better range of motion.	Change from baseline Passive Range of Motion at 14 days
Pain intensity change	Visual Analogue Scale (VAS); the greater the value on the 0.1 meters line, the greater the pain intensity starting from 0 (no pain at all) to 10 (the highest pain intensity ever experienced).	Change from baseline Visual Analogue Scale at 14 days
Step length change	Step length (meters); ranges from 0-0.5 meters, the higher the step length leads to better outcome.	Change from baseline step length at 14 days
Knee flexion-extension change	Knee flexion-extension; Maximum and minimum angle value in the sagittal plane of knee, from 0 degrees in full extension to 140-150 degrees in maximum flexion.	Change from baseline knee flexion-extension at 14 days

Collaborators and Investigators

• Sponsor: Carol Davila University of Medicine and Pharmacy
• Investigators: Study Director: Mihai Berteanu, Elias University Emergency Hospital, Bucharest, Romania

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2021
• Primary Completion (Actual): June 1, 2022
• Study Completion (Actual): August 1, 2022

Study Registration Dates

• First Submitted: December 24, 2021
• First Submitted That Met QC Criteria: January 11, 2022
• First Posted (Actual): January 25, 2022

Study Record Updates

• Last Update Posted (Actual): February 16, 2023
• Last Update Submitted That Met QC Criteria: February 15, 2023
• Last Verified: February 1, 2023

More Information

Terms related to this study

• Keywords: stroke; neurological rehabilitation; spasticity; radial extracorporeal shock wave therapy; gait analysis system
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurologic Manifestations; Musculoskeletal Diseases; Muscular Diseases; Neuromuscular Manifestations; Muscle Hypertonia; Stroke; Ischemic Stroke; Muscle Spasticity; Hemorrhagic Stroke; Gait Disorders, Neurologic
• Other Study ID Numbers: 2090

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No