Skip to main content
OpenTrials
Completed

NCT Number: NCT05206240

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Stroke, Ischemic Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Gait Disorders, Neurologic Hemorrhagic Stroke Ischemic Stroke Muscle Hypertonia Muscle Spasticity Muscular Diseases Musculoskeletal Diseases Nervous System Diseases Neurologic Manifestations Neuromuscular Manifestations Pathological Conditions, Signs and Symptoms Signs and Symptoms Spastic Gait Spasticity, Muscle Stroke Stroke Hemorrhagic Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Elias University Emergency Hospital

Bucharest, Romania

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Radial extracorporeal shock wave therapy and conventional physical therapy

Other

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.

Primary outcomes

  1. Spasticity grade change

    Time frame: Change from baseline Modified Ashworth Scale at 14 days

    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.

Secondary outcomes

  1. Ankle passive range of motion change

    Time frame: Change from baseline Passive Range of Motion at 14 days

    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.

  2. Pain intensity change

    Time frame: Change from baseline Visual Analogue Scale at 14 days

    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).

  3. Step length change

    Time frame: Change from baseline step length at 14 days

    Step length (meters); ranges from 0-0.5 meters, the higher the step length leads to better outcome.

  4. Knee flexion-extension change

    Time frame: Change from baseline knee flexion-extension at 14 days

    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.

Sponsors and collaborators

Lead sponsor

Carol Davila University of Medicine and Pharmacy

Other

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Jan 25, 2022
Registry last updated
Feb 16, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.