Clinical trial NCT05206240: Extracorporeal Shock Wave Therapy and Assessment Strategy Through a Novel Gait Analysis Tool for Post-stroke Spasticity
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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Stroke, Ischemic
Stroke Hemorrhagic
Spasticity, Muscle
Spastic Gait
Keywords: stroke
spasticity
neurological rehabilitation
radial extracorporeal shock wave therapy
gait analysis system
Lead sponsor: Carol Davila University of Medicine and Pharmacy
Sponsor class: OTHER
First posted: 2022-01-25
Enrollment: 15
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Inpatients from the Physical and Rehabilitation Medicine Department stating the eligibility criteria

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.

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.

Primary outcomes:
measure: Spasticity grade change
timeFrame: Change from baseline Modified Ashworth Scale at 14 days
Secondary outcomes:
measure: Ankle passive range of motion change
timeFrame: Change from baseline Passive Range of Motion at 14 days
measure: Pain intensity change
timeFrame: Change from baseline Visual Analogue Scale at 14 days
measure: Step length change
timeFrame: Change from baseline step length at 14 days
measure: Knee flexion-extension change
timeFrame: Change from baseline knee flexion-extension at 14 days
Other outcomes:
Locations:
city: Bucharest
country: Romania
facility: Elias University Emergency Hospital
Study officials:
affiliation: Elias University Emergency Hospital, Bucharest, Romania
name: Mihai Berteanu
role: STUDY_DIRECTOR
References: