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

NCT05206240 | Completed

• 1 other identifier: 2090
• Study Type: observational
• Target: 15
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

stroke; spasticity; neurological rehabilitation; radial extracorporeal shock wave therapy; gait analysis system

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• 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

Study Arms (1)

Study group

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).

Other: Radial extracorporeal shock wave therapy and conventional physical therapy

Interventions

Radial extracorporeal shock wave therapy and conventional physical therapy OTHER

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.

Study group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Inpatients from the Physical and Rehabilitation Medicine Department stating the eligibility criteria

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Carol Davila University of Medicine and Pharmacy: lead

Study Sites (1)

Elias University Emergency Hospital

Bucharest, Romania

Location

MeSH Terms

Conditions

Ischemic Stroke; Hemorrhagic Stroke; Muscle Spasticity; Gait Disorders, Neurologic; Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Muscular Diseases; Musculoskeletal Diseases; Muscle Hypertonia; Neuromuscular Manifestations; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Mihai Berteanu

  Elias University Emergency Hospital, Bucharest, Romania

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: December 24, 2021
• First Posted: January 25, 2022
• Study Start: March 1, 2021
• Primary Completion: June 1, 2022
• Study Completion: August 1, 2022
• Last Updated: February 16, 2023

Record last verified: 2023-02

Data Sharing

• IPD Sharing: Will not share

Locations

RO (1)