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Completed

NCT Number: NCT05255549

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

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).

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Key information

Conditions

Stroke Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Nervous System Diseases Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Operational Unit of Physical Medicine and Rehabilitation AUSL - IRCCS Reggio Emilia

Reggio Emilia, Emilia-Romagna, 42123, Italy

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

ESWT + Stretching

Procedure

3 weeks intervention:

  • 3 sessions of ESWT, once a week
  • 6 sessions of passive stretching, twice a week

ESWT and SHAM + Stretching

Procedure

3 weeks intervention:

  • 1 sessions of ESWT + 2 sessions of Sham, once a week
  • 6 sessions of passive stretching, twice a week

Primary outcomes

  1. Feasibility of two kind treatments proposed

    Time frame: T1 after 4 weeks from T0 (Enrollment)

    The intervention is feasible if at least 80% of the enrolled patients complete the entire treatment foreseen in the allocation group

Secondary outcomes

  1. Change in Walking Resistance

    Time frame: T0 Enrollment, T1 after 4 weeks from T0, T2 after 12 weeks from T0

    6 minute walking test

  2. Change in Level of mobility and balance

    Time frame: T0 Enrollment, T1 after 4 weeks from T0, T2 after 12 weeks from T0

    Timed Up & Go Test

  3. Change in spasticity

    Time frame: T0 Enrollment, T1 after 4 weeks from T0, T2 after 12 weeks from T0

    Modified Ashworth Scale (MAS). Score from 0 to 4, higher scores mean a worse outcome

  4. Change in Passive ROM of the ankle in dorsiflexion

    Time frame: T0 Enrollment, T1 after 4 weeks from T0, T2 after 12 weeks from T0

    Passive ankle Range of Motion (p-ROM)

  5. Change in Leg Pain

    Time frame: T0 Enrollment, T1 after 4 weeks from T0, T2 after 12 weeks from T0

    Numeric Pain Rating Scale (NPRS) Score from 0 to 10, higher scores mean a worse outcome

  6. Change in Ability to carry out activities of daily living

    Time frame: T0 Enrollment, T1 after 4 weeks from T0, T2 after 12 weeks from T0

    Lower Extremity Functional Scale (LEFS). Score from 0 to 80, higher scores mean a better outcome.

  7. Change in triceps clones

    Time frame: T0 Enrollment, T1 after 4 weeks from T0, T2 after 12 weeks from T0

    Presence of ankle clonus

Sponsors and collaborators

Lead sponsor

Azienda USL Reggio Emilia - IRCCS

Other Gov

Registry information

Official study title

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

Acronym: Waves2021

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Feb 24, 2022
Registry last updated
Jun 24, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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