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

Stroke, Ischemic Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05206240
• Other study ID #: 2090
• Status: Completed
• Start date: March 1, 2021
• Est. completion date: August 1, 2022

Study information

• Verified date: February 2023
• Source: Carol Davila University of Medicine and Pharmacy
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 15
• Est. completion date: August 1, 2022
• Est. primary completion date: June 1, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Gait Disorders, Neurologic
• Hemorrhagic Stroke
• Ischemic Stroke
• Muscle Spasticity
• Spastic Gait
• Spasticity, Muscle
• Stroke
• Stroke Hemorrhagic
• Stroke, Ischemic

Intervention

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.

Locations

Country	Name	City	State
Romania	Elias University Emergency Hospital	Bucharest

Sponsors (1)

Lead Sponsor	Collaborator
Carol Davila University of Medicine and Pharmacy

Country where clinical trial is conducted

Romania, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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