Feasibility of ESWT Treatment in Post-stroke Patients With Triceps Sural Spasticity (Waves2021)

ESWT Treatment in Post-stroke Patients With Triceps Sural: a Feasibility RCT

The main objective is to evaluate the feasibility of two different rehabilitation protocols that differed from the number of treatment sessions (1 session of ESWT versus 3 weekly sessions of ESWT), in patients with triceps surae spasticity after stroke. In both arms the other ESWT parameters (types of ESWT, intensity, frequency, location) and stretching sessions are the same.

Secondary objectives: to compare functional performances in these two groups of patients receiving the different rehabilitation protocol with ESWT, using the following parameters:

- Six Minutes walking test (6MWT) ; - Time Up & Go (TUG); - Modified Ashworth scale (MAS); - Lower Extremity Functional Scale (LEFS); - passive ankle range of motion (p-ROM), pain (NRS); and presence of ankle clonus. These parameters are assessed during baseline (T0), after 4 weeks (T1) and after 12 weeks (T2).

Study Overview

• Status: Recruiting
• Conditions: Stroke
• Intervention / Treatment: Procedure: ESWT + Stretching; Procedure: ESWT and SHAM + Stretching

• Study Type: Interventional
• Enrollment (Anticipated): 30
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Stefania Testoni, Dr; Phone Number: +39 0522296163; Email: stefania.testoni@ausl.re.it

Study Locations

• Italy
  • Emilia Romagna
    • Reggio Emilia, Emilia Romagna, Italy, 42123
      • Recruiting
      • Operational Unit of Physical Medicine and Rehabilitation AUSL - IRCCS Reggio Emilia
      • Contact: Stefania Testoni, Dr; Phone Number: +39 0522296163

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Adult patients of legal age
• Time elapsed since the stroke between 6 and 60 months
• Autonomous or supervised walking with or without aids
• Spasticity of the sural triceps> 1 on the MAS scale

Exclusion Criteria:

• Joint stiffness of the lower limbs due to other pathologies (ex orthopedic or rheumatological);
• Conditions that interfere with evaluation or collaboration in rehabilitation treatment (major psychiatric illnesses, clearly detectable cognitive deficits, severe pre-existing disabilities, sensory disturbances, etc.)
• Focal antispasmodic toxin treatments in the previous 3 months or phenolic blocks in the previous 9 months in the treatment region
• Treatments with central antispasmodic drugs with dosage modifications in the last week of starting treatment
• Individual neurorehabilitation treatments in progress

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Group I	Procedure: ESWT + Stretching; 3 weeks intervention: 3 sessions of ESWT, once a week; 6 sessions of passive stretching, twice a week
Sham Comparator: Group II	Procedure: ESWT and SHAM + Stretching; 3 weeks intervention: 1 sessions of ESWT + 2 sessions of Sham, once a week; 6 sessions of passive stretching, twice a week

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Feasibility of two kind treatments proposed	The intervention is feasible if at least 80% of the enrolled patients complete the entire treatment foreseen in the allocation group	T1 after 4 weeks from T0 (Enrollment)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Walking Resistance	6 minute walking test	T0 Enrollment, T1 after 4 weeks from T0, T2 after 12 weeks from T0
Change in Level of mobility and balance	Timed Up & Go Test	T0 Enrollment, T1 after 4 weeks from T0, T2 after 12 weeks from T0
Change in spasticity	Modified Ashworth Scale (MAS). Score from 0 to 4, higher scores mean a worse outcome	T0 Enrollment, T1 after 4 weeks from T0, T2 after 12 weeks from T0
Change in Passive ROM of the ankle in dorsiflexion	Passive ankle Range of Motion (p-ROM)	T0 Enrollment, T1 after 4 weeks from T0, T2 after 12 weeks from T0
Change in Leg Pain	Numeric Pain Rating Scale (NPRS) Score from 0 to 10, higher scores mean a worse outcome	T0 Enrollment, T1 after 4 weeks from T0, T2 after 12 weeks from T0
Change in Ability to carry out activities of daily living	Lower Extremity Functional Scale (LEFS). Score from 0 to 80, higher scores mean a better outcome.	T0 Enrollment, T1 after 4 weeks from T0, T2 after 12 weeks from T0
Change in triceps clones	Presence of ankle clonus	T0 Enrollment, T1 after 4 weeks from T0, T2 after 12 weeks from T0

Collaborators and Investigators

• Sponsor: Azienda Unità Sanitaria Locale Reggio Emilia
• Investigators: Principal Investigator: Stefania Testoni, Dr, Azienda AUSLRE

Study record dates

Study Major Dates

• Study Start (Actual): July 22, 2021
• Primary Completion (Anticipated): July 22, 2022
• Study Completion (Anticipated): July 22, 2022

Study Registration Dates

• First Submitted: February 5, 2022
• First Submitted That Met QC Criteria: February 15, 2022
• First Posted (Actual): February 24, 2022

Study Record Updates

• Last Update Posted (Actual): February 24, 2022
• Last Update Submitted That Met QC Criteria: February 15, 2022
• Last Verified: November 1, 2021

More Information

Terms related to this study

• Keywords: Stroke; Extracorporeal Shockwave Therapy; Triceps Sural Spasticity
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Stroke
• Other Study ID Numbers: 31032021

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No