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

Carol Davila University of Medicine and Pharmacy

Status: Completed

Conditions: Spasticity, Muscle; Stroke Hemorrhagic; Stroke, Ischemic; Spastic Gait

Treatments: Other: Radial extracorporeal shock wave therapy and conventional physical therapy

Study type: Observational

Funder types: Other

Identifiers

NCT05206240

2090

Details and patient eligibility

About

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.

Full 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.

Enrollment: 15 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

15 participants in 1 patient group

Study group

Description:

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).

Treatment:

Other: Radial extracorporeal shock wave therapy and conventional physical therapy