Efficacy of Extracorporeal Shock Wave Therapy and Assessment Strategy Through a Novel Gait Analysis Tool for Post-stroke Spasticity During COVID-19 Pandemic
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Stroke, Ischemic
- Sponsor
- Carol Davila University of Medicine and Pharmacy
- Enrollment
- 15
- Locations
- 1
- Primary Endpoint
- Spasticity grade change
- Status
- Completed
- Last Updated
- 3 years ago
Overview
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.
Investigators
Emanuela Elena Mihai
Principal Investigator
Carol Davila University of Medicine and Pharmacy
Eligibility Criteria
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.
Outcomes
Primary Outcomes
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
- Ankle passive range of motion change(Change from baseline Passive Range of Motion at 14 days)
- Pain intensity change(Change from baseline Visual Analogue Scale at 14 days)
- Step length change(Change from baseline step length at 14 days)
- Knee flexion-extension change(Change from baseline knee flexion-extension at 14 days)