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

Completed

• Conditions: Stroke, Ischemic; Stroke Hemorrhagic; Spastic Gait; Spasticity, Muscle
• Interventions: Other: Radial extracorporeal shock wave therapy and conventional physical therapy

• Registration Number: NCT05206240
• Lead Sponsor: Carol Davila University of Medicine and Pharmacy

Brief Summary

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.

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 Timeline

• Study Start: 2021-03-01
• Study First Submitted: 2021-12-24
• Study First Submitted QC: 2022-01-11
• Study First Posted: 2022-01-25
• Primary Completion: 2022-06-01
• Study Completion: 2022-08-01
• Status Verified: 2023-02
• Last Update Submitted: 2023-02-15
• Last Update Posted: 2023-02-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 15

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Study group	Radial extracorporeal shock wave therapy and conventional physical therapy	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).

Primary Outcome Measures

Name	Time	Method
Spasticity grade change	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 Outcome Measures

Name	Time	Method
Ankle passive range of motion change	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.
Pain intensity change	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).
Step length change	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.
Knee flexion-extension change	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.

Trial Locations

Locations (1)

Elias University Emergency Hospital; 🇷🇴 Bucharest, Romania