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

Stroke Clinical Trial

— Waves2021  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05255549
• Other study ID #: 31032021
• Status: Recruiting
• Phase: N/A
• Start date: July 22, 2021
• Est. completion date: July 22, 2022

Study information

• Verified date: November 2021
• Source: Azienda Unità Sanitaria Locale Reggio Emilia
• Contact: Stefania Testoni, Dr
• Phone: +39 0522296163
• Email: stefania.testoni[@]ausl.re.it
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: July 22, 2022
• Est. primary completion date: July 22, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Stroke

Intervention

Procedure:
• ESWT + Stretching
3 weeks intervention: 3 sessions of ESWT, once a week 6 sessions of passive stretching, twice a week
• 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

Locations

Country	Name	City	State
Italy	Operational Unit of Physical Medicine and Rehabilitation AUSL - IRCCS Reggio Emilia	Reggio Emilia	Emilia Romagna

Sponsors (1)

Lead Sponsor	Collaborator
Azienda Unità Sanitaria Locale Reggio Emilia

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Change in Walking Resistance	6 minute walking test	T0 Enrollment, T1 after 4 weeks from T0, T2 after 12 weeks from T0
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Change in triceps clones	Presence of ankle clonus	T0 Enrollment, T1 after 4 weeks from T0, T2 after 12 weeks from T0