Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05206240
Other study ID # 2090
Secondary ID
Status Completed
Phase
First received
Last updated
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
Health authority
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.

Study Design


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
See also
  Status Clinical Trial Phase
Recruiting NCT03993236 - Study on Rosuvastatin+Ezetimibe and Rosuvastatin for LDL-C Goal in Patients With Recent Ischemic Stroke Phase 4
Completed NCT04069767 - Innovative Physiotherapy in Stroke Rehabilitation N/A
Recruiting NCT06342206 - The Assessment of Acute /Chronic Phase in Patients With Ischemic Cerebral Stroke Using TCM Diagnostic Tools
Recruiting NCT03605381 - MORbidity PRevalence Estimate In StrokE
Enrolling by invitation NCT04956211 - Periodontal Treatment and Ischemic Stroke N/A
Active, not recruiting NCT05098236 - Effect of Visual Retraining on Visual Loss Following Visual Cortical Damage N/A
Completed NCT03942588 - High-intensity Interval Training After Stroke N/A
Recruiting NCT04949334 - Effects of Respiratory Muscle Training in Patients With Acute Ischemic Stroke N/A
Terminated NCT04095767 - Assessing Safety and Performance of the ANA Catheter System, Combined With a Stent Retriever in Acute Ischemic Stroke N/A
Not yet recruiting NCT06352086 - Understanding Visual Processing After Occipital Stroke
Withdrawn NCT04991038 - Clinical Investigation to Compare Safety and Efficacy of DAISE and Stent Retrievers for Thrombectomy In Acute Ischemic Stroke Patients N/A
Completed NCT01937182 - The Efficacy of Citalopram Treatment in Acute Stroke Phase 2
Completed NCT03649295 - Combined Conventional Speech Therapy and Functional Electrical Stimulation in Dysphagia Following Stroke N/A
Recruiting NCT05303649 - Effects of Neuronavigated Theta Burst Stimulation in Therapy of Post-stroke Aphasia N/A
Completed NCT04233515 - Use of Oral Anticoagulants and Symptoms in Patients With Atrial Fibrillation in Örebro County
Completed NCT05102877 - Sensory Versus Motor Level Neuromuscular Electrical Stimulation N/A
Completed NCT04089917 - A Study of the Use of the Q Aspiration Catheter to Remove Clot in Stroke Patients
Completed NCT05221112 - Effects of PNF Patterns Training on Trunk Balance, and Gait in Chronic Stroke Patients N/A
Not yet recruiting NCT05035953 - Thrombolysis Combined With Edaravone Dexborneol on Hemorrhagic Transformation for Acute Ischemic Stroke Phase 2
Completed NCT06326801 - Resistive Diaphragmatic Breathing Exercise With Pursed Lips Breathing Exercise in Sub-acute Stroke Patients N/A