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Radial Extracorporeal Shock Wave Therapy and Visual Feedback Balance Training on Lower Limb Post-Stroke Spasticity, Trunk Performance and Balance:

Primary Purpose

Stroke, Ischemic, Stroke Hemorrhagic, Spasticity as Sequela of Stroke

Status
Active
Phase
Not Applicable
Locations
Romania
Study Type
Interventional
Intervention
radial extracorporeal shock wave therapy
sham radial extracorporeal shock wave therapy
Sponsored by
Carol Davila University of Medicine and Pharmacy
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Stroke, Ischemic focused on measuring stroke, spasticity, balance trainer, balance impairment, neurologic rehabilitation

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • a hemorrhagic or ischemic stroke in acute, subacute or chronic phase;
  • no history of previous stroke;
  • 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 unassisted in upright position for 30 seconds;
  • no change in anti-spastic drug dose or treatment and no changes in analgesic medication, as it could affect the results on the Modified Ashworth Scale and the Visual Analogue Scale
  • adult patients (>18 years old)

Exclusion Criteria:

  • other neurological and orthopaedic disorders or lower limb deformities that could in-terfere with motor performance and balance;
  • myopathies;
  • severe cognitive impairment, severe aphasia or inability to understand instructions;
  • severe spasticity;
  • visual field conditions or hemineglect;
  • patients unable to undergo follow-up evaluation and excluded from the final analysis;
  • anticoagulant medication or any contraindication to receive radial extracorporeal shockwave therapy (rESWT), or any contraindication to physical therapy.

Sites / Locations

  • Elias University Emergency Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Sham Comparator

Arm Label

Conventional physiotherapy, visual feedback training, rESWT

Conventional physiotherapy, visual feedback training, sham rESWT

Arm Description

conventional physiotherapy (5 times/week), visual feedback training (5 times/week), radial extracorporeal shock wave therapy (once/week for 2 weeks)

conventional physiotherapy (5 times/week), visual feedback training (5 times/week), sham radial extracorporeal shock wave therapy (once/week for 2 weeks)

Outcomes

Primary Outcome Measures

Spasticity grade change
The Modified Ashworth Scale (MAS)

Secondary Outcome Measures

Range of motion change
passive range of motion (PROM) parameter measured through a hand-held goniometer
Pain intensity change
Visual Analogue Scale (VAS) through a vertical 10-cm line (0 - starting pain-free to 10 - the worst imaginable pain). The higher the score means a worse outcome.
Stabilometric outcomes change
Prokin system (PK 252, TecnoBody, Bergamo, Italy) parameters: trunk (degrees), stance (degrees), static (mm^2) and dynamic balance (mm^2)

Full Information

First Posted
December 21, 2021
Last Updated
November 30, 2022
Sponsor
Carol Davila University of Medicine and Pharmacy
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1. Study Identification

Unique Protocol Identification Number
NCT05196633
Brief Title
Radial Extracorporeal Shock Wave Therapy and Visual Feedback Balance Training on Lower Limb Post-Stroke Spasticity, Trunk Performance and Balance:
Official Title
Effectiveness of Radial Extracorporeal Shock Wave Therapy and Visual Feedback Balance Training on Lower Limb Post-Stroke Spasticity, Trunk Performance and Balance: A Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
November 2022
Overall Recruitment Status
Active, not recruiting
Study Start Date
January 1, 2021 (Actual)
Primary Completion Date
November 30, 2022 (Actual)
Study Completion Date
August 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Carol Davila University of Medicine and Pharmacy

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
This study assess the relationship between lower limb spasticity and trunk movements during static and dynamic balance in post-stroke patients who also underwent conventional physical therapy, visual feedback balance training and radial extracorporeal shock wave therapy intervention.
Detailed Description
The stabilometric assessment through Prokin system complemented the clinical evaluation and provided a more objective, global insight into the combined therapeutic effect. The stabilometric computerized system is both an assessment tool and a training system for static, dynamic balance and trunk. To date, it was used in various clinical trials as a training tool for promoting stance and balance improvement in several neurorehabilitation programs. Additional outcomes focused on the effectiveness on pain intensity, clonus, passive range of motion, lower limb sensorimotor function, and functionality. The adverse events were also attentively monitored during the trial.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke, Ischemic, Stroke Hemorrhagic, Spasticity as Sequela of Stroke, Spastic Gait, Balance; Distorted
Keywords
stroke, spasticity, balance trainer, balance impairment, neurologic rehabilitation

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
50 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Conventional physiotherapy, visual feedback training, rESWT
Arm Type
Experimental
Arm Description
conventional physiotherapy (5 times/week), visual feedback training (5 times/week), radial extracorporeal shock wave therapy (once/week for 2 weeks)
Arm Title
Conventional physiotherapy, visual feedback training, sham rESWT
Arm Type
Sham Comparator
Arm Description
conventional physiotherapy (5 times/week), visual feedback training (5 times/week), sham radial extracorporeal shock wave therapy (once/week for 2 weeks)
Intervention Type
Other
Intervention Name(s)
radial extracorporeal shock wave therapy
Intervention Description
rESWT (Endopuls 811; Enraf Nonius B.V. Va-reseweg 127, 3047 AT Rotterdam MedTech, Wessling, Germany) will be applied on the myotendinous junction of both the gastrocnemius and the soleus muscles in post-stroke spasticity patients. 2000 shots will be applied on the gastrocnemius and soleus myotendinous junction with a frequency of 10 Hz and energy density of 60 mJ (1 bar) within tolerable pain limits.
Intervention Type
Other
Intervention Name(s)
sham radial extracorporeal shock wave therapy
Intervention Description
The control group will receive sound over the myotendinous junction of gastrocnemius and soleus with transducer-like contact.
Primary Outcome Measure Information:
Title
Spasticity grade change
Description
The Modified Ashworth Scale (MAS)
Time Frame
Change from baseline Modified Ashworth Scale at 14 days
Secondary Outcome Measure Information:
Title
Range of motion change
Description
passive range of motion (PROM) parameter measured through a hand-held goniometer
Time Frame
Change from baseline Passive Range of Motion at 14 days
Title
Pain intensity change
Description
Visual Analogue Scale (VAS) through a vertical 10-cm line (0 - starting pain-free to 10 - the worst imaginable pain). The higher the score means a worse outcome.
Time Frame
Change from baseline Visual Analogue Scale at 14 days
Title
Stabilometric outcomes change
Description
Prokin system (PK 252, TecnoBody, Bergamo, Italy) parameters: trunk (degrees), stance (degrees), static (mm^2) and dynamic balance (mm^2)
Time Frame
Change from baseline Prokin system parameters at 14 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: a hemorrhagic or ischemic stroke in acute, subacute or chronic phase; no history of previous stroke; 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 unassisted in upright position for 30 seconds; no change in anti-spastic drug dose or treatment and no changes in analgesic medication, as it could affect the results on the Modified Ashworth Scale and the Visual Analogue Scale adult patients (>18 years old) Exclusion Criteria: other neurological and orthopaedic disorders or lower limb deformities that could in-terfere with motor performance and balance; myopathies; severe cognitive impairment, severe aphasia or inability to understand instructions; severe spasticity; visual field conditions or hemineglect; patients unable to undergo follow-up evaluation and excluded from the final analysis; anticoagulant medication or any contraindication to receive radial extracorporeal shockwave therapy (rESWT), or any contraindication to physical therapy.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mihai Berteanu
Organizational Affiliation
Physical and Rehabilitation Medicine Department, Elias University Emergency Hospital
Official's Role
Study Director
Facility Information:
Facility Name
Elias University Emergency Hospital
City
Bucharest
ZIP/Postal Code
011461
Country
Romania

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Radial Extracorporeal Shock Wave Therapy and Visual Feedback Balance Training on Lower Limb Post-Stroke Spasticity, Trunk Performance and Balance:

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