Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12616001057471
Ethics application status
Approved
Date submitted
15/07/2016
Date registered
8/08/2016
Date last updated
9/03/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
The Effect of Extracorporeal Shock Wave Therapy on Lower Limb Spasticity in Stroke Patients
Scientific title
The Effect of Extracorporeal Shock Wave Therapy on the Spasticity of Ankle Plantar Flexor Muscles in Poststroke Patients: a Single Blind Randomized Controlled Study
Secondary ID [1] 289597 0
Nil known
Universal Trial Number (UTN)
U1111-1185-3674
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Spasticity 299368 0
Stroke 299665 0
Condition category
Condition code
Physical Medicine / Rehabilitation 299354 299354 0 0
Other physical medicine / rehabilitation
Stroke 299607 299607 0 0
Haemorrhagic
Stroke 299608 299608 0 0
Ischaemic

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Extracorporeal shock wave therapy (ESWT) is a new technology using a ballistic source to generate pressure waves. The shock waves can be radial or focused. Radial ESWT (rESWT) compared with focused ESWT, is a low to medium energy shock wave with a low penetration power and can be used for the treatment of the large body regions. Recently ESWT has been suggested as a non -invasive, alternative treatment of spasticity. This study is planned as a single-blind, randomized controlled trial. Participants are randomly allocated to three groups; the ESWT group, the sham ESWT group and the control group. Radial ESWT (rESWT) will be delivered in this study. Both the ESWT groups and the control group will receive a conventional exercise therapy incluiding range of motion and stretching exercise twice a day during their stay in the hospital. The exercise therapy is administered to patients as a part of standard care of stroke rehabilitation during their stay in the hospital.The ESWT group will receive conventional exercise therapy plus radial ESWT (rESWT) two sessions per week for two weeks (total 4 sessions). Each session will last for 2-5 minutes. 1500 shots are delivered to gastrocnemius muscle of the affected side with a frequency of 10 Hz and pressure of 2 Bars. Sham ESWT group will receive conventional exercise therapy plus radial ESWT(rESWT) two sessions per week for two weeks (total 4 sessions). Each session will last for 2-5 minutes. 100 shots are delivered to gastrocnemius muscle of the affected side with a frequency of 1 Hz and pressure of 1 Bar. Intelect RPW Shockwave by Chattanooga Corporation will be used to deliver stimulation to the spastic muscle. Radial ESWT (rESWT) will be delivered to all patients by the same physiotherapist at least 10 years of experience in Department of PMR of Ibni Sina Hospital. The attendence of patients at ESWT sessions will be monitor by his neurorehabilitation team.
Intervention code [1] 295206 0
Treatment: Devices
Intervention code [2] 295437 0
Treatment: Other
Intervention code [3] 295438 0
Rehabilitation
Comparator / control treatment
1.. Sham Comparator: Sham ESWT
Sham ESWT group will receive conventional exercise therapy plus radial ESWT two sessions per week for two weeks (total 4 sessions). 100 shots will be delivered to gastrocnemius muscle of the affected side with a frequency of 1 Hz and pressure of 1 Bar. Intelect RPW Shockwave by Chattanooga Corporation will be used to deliver stimulation to the spastic muscle. ESWT will be delivered by a physiotherapist at least 10 years of experience in Department of PMR of Ibni Sina Hospital.

2. No Intervention: Control group
Control group receive only conventional exercise therapy incluiding range of motion and stretching exercise twice a day during their stay in the hospital. The exercise therapy will be given by a physiotherapist at least 5 years of experience.

Control group
Placebo

Outcomes
Primary outcome [1] 298911 0
Modified Ashworth Scale :Change in spasticity grade of affected side of ankle plantar flexor muscles assessed using Modified Ashworth Scale
Timepoint [1] 298911 0
At baseline, immediately after the last ESWT session, 4 weeks after the last ESWT session
Secondary outcome [1] 325630 0
Clonus score: Severity of spasticity assessed using the Clonus score
Timepoint [1] 325630 0
At baseline, immediately after the last ESWT session, 4 weeks after the last ESWT session
Secondary outcome [2] 325631 0
Ankle Range of motion measurement of affected side assessed by using a goniometer.
Timepoint [2] 325631 0
At baseline, immediately after the last ESWT session, 4 weeks after the last ESWT session
Secondary outcome [3] 325632 0
6 meter walk time test . Physical function assessed using 6 meter walk time test.
Timepoint [3] 325632 0
At baseline, immediately after the last ESWT session, 4 weeks after the last ESWT session
Secondary outcome [4] 325636 0
Performance in activities of daily living assessed using Barthel index
Timepoint [4] 325636 0
At baseline, immediately after the last ESWT session, 4 weeks after the last ESWT session
Secondary outcome [5] 325637 0
Motor recovery of the lower extremity assessed using Brunnstrom motor recovery stage of the affected lower extremity.
Timepoint [5] 325637 0
At baseline, immediately after the last ESWT session, 4 weeks after the last ESWT session
Secondary outcome [6] 325737 0
Stiffness of affected side of gastrocnemius muscle assessed using Ultrasound Elastography
Timepoint [6] 325737 0
At baseline, immediately after the last ESWT session, 4 weeks after the last ESWT session

Eligibility
Key inclusion criteria
1. Ischemic or hemorrhagic stroke occurring in any time
2. Between 18 and 70 years of age
3. More or equal to Grade 1 spasticity in the affected side gastrocnemius muscle according to Modified Ashworth Scale
4. The general health condition of patient after stroke is stable


Minimum age
18 Years
Maximum age
70 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Patients treated with Botulinum toxin, phenol or alcohol injection for spasticity in the last 6 months
2.Patients with ankle contracture or severe inflammation in treatment sites
3. Patients with cardiac pacemaker
4. Patients with cancer in or around the treatment area
5. Patients with history of previous antispastic surgery interventions in the area of the ankle
6. Patients with changes in the use of oral antispastic medication in the last 6 months
7. Patients with bleeding diathesis
8. Patients with vascular complaints such as deep vein thrombosis, phlebitis, varicose veins in treatment sites

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
A sealed opaque envelope method will be used to ensure privacy.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Patients will be randomized into three groups . For this purpose Random Allocation Software (RAS) program will be used.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Mean, standard deviation, median, min-max and percentile values will be calculated for the socio-demographic and clinical features, primary and secondary outcome measures by descriptive statistics.The one way Anova test will be used to evaluate differences within groups for parametric measures. The Mann Whitney U test will be used to evaluate differences between groups for non parametric measures. The relationship between clinical results and the ultrasound elastography will be evaluated by Spearman’s test. P value of less than .05 was considered as statistically significant. When the power analysis was made by taken MAS as primary outcome variable of the study, Power of the study was calculated to 80% with 18 patients in each group using effect size of 0,45. A total of at least 54 patients are planned to be included in the study.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/10/2016
Actual
1/10/2016
Date of last participant enrolment
Anticipated
1/10/2017
Actual
18/12/2017
Date of last data collection
Anticipated
15/11/2017
Actual
30/01/2018
Sample size
Target
54
Accrual to date
Final
56
Recruitment outside Australia
Country [1] 8025 0
Turkey
State/province [1] 8025 0
Ankara

Funding & Sponsors
Funding source category [1] 294045 0
Hospital
Name [1] 294045 0
Ankara University Faculty of Medicine Ibni Sina Hospital Department of PMR
Country [1] 294045 0
Turkey
Primary sponsor type
University
Name
Ankara University
Address
Ankara University Faculty of Medicine
Sihhiye 06100
Turkey
Country
Turkey
Secondary sponsor category [1] 292870 0
None
Name [1] 292870 0
Address [1] 292870 0
Country [1] 292870 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 295460 0
Ankara University Faculty of Medicine Ethics Committee
Ethics committee address [1] 295460 0
Ankara University Faculty of Medicine Ethics Committee

SIHHIYE /ANKARA
Ethics committee country [1] 295460 0
Turkey
Date submitted for ethics approval [1] 295460 0
02/12/2015
Approval date [1] 295460 0
24/12/2015
Ethics approval number [1] 295460 0
19-797-15

Summary
Brief summary
Spasticity is one of the most important causes of disability in stroke patients; it interferes with the patients rehabilitation, especially regarding functional recovery. Spasticity should be appropriately treated because it causes pain , postural abnormality and decreasing in range of movement, thereby hindering patients ability for daily living and affecting the quality of life. The first step in the treatment of spasticity is physical therapy that includes positioning and appropriate exercise programs. Oral anti-spasticity drugs, motor point block using phenol, alcohol and botilinium toxin injection, intrathecal baclofen and surgery can be used for the second step. The necessity of new noninvasive treatment methods for spasticity has been raised because spasiticity can not be controlled sometimes even diverse treatment methods as well as due to the side effects of oral drugs and the invasiveness of local treatment methods. Recently extracorporeal shock wave therapy (ESWT) has been suggested as a non –invasive, alternative treatment of spasticity. The shock waves can be radial or focused . Manganotti demonstrated the safety and effectiveness of a single ESWT session in reducing spasticity of wrist and finger flexors in 20 patients. Within the available literature there are only few studies that investigated the effect of radial ESWT on spasticity in stroke patients. Fauda demonstrated a significant decrease in spasticity of wrist and finger flexor muscles after rESWT. The standard dose, duration and number of sessions of rESWT for the treatment of spasticity has not been fully determined yet. The aim of this study was to evaluate the effectiveness of rESWT in lower extremity plantar flexor spasticity in stroke patients and to reveal the relationship of this effect with the fibroelastic components of the muscle.
This study is planned as a single-blind, randomized controlled trial. Stroke patients with ankle plantar flexor spasticity more than grade 1 according to the modified ashworth scale who were hospitalized for inpatient rehabilitation at the Ankara University Faculty of Medicine, PMR Clinic , Patients are assessed to determine their eligibility for the study. All patients who fulfilled the inclusion criteria receive a detailed explanation of the study and written informed consent is obtained from all participants prior to enrollment. Participants are randomly allocated to three groups; the ESWT group, the sham ESWT group and the control group.The primary outcome measure of this study is the grade of the spasticity according to the modified ashworth scale.The primary endpoint of the study is to determine a decrease in spasticity grade at least one point.To determine the fibroelastic components of the spastic muscles, ultrason elastography is used as secondary outcome measure. The secondary endpoint of this study is to provide improvement of the fibroelastic properties and reduction in the stiffness of the spastic muscles.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 67142 0
Prof Sehim Kutlay
Address 67142 0
Ankara University Faculty of Medicine
Department of PMR Ibni Sina Hospital
Sihhiye 06100
Ankara
Country 67142 0
Turkey
Phone 67142 0
+90 312 5082940
Fax 67142 0
+90 312 5083935
Email 67142 0
[email protected]
Contact person for public queries
Name 67143 0
Prof Sehim Kutlay
Address 67143 0
Ankara University Faculty of Medicine
Department of PMR Ibni Sina Hospital
Sihhiye 06100
Ankara
Country 67143 0
Turkey
Phone 67143 0
+90 312 5082940
Fax 67143 0
+90 312 5083935
Email 67143 0
[email protected]
Contact person for scientific queries
Name 67144 0
Prof Sehim Kutlay
Address 67144 0
Ankara University Faculty of Medicine
Department of PMR Ibni Sina Hospital
Sihhiye 06100
Ankara
Country 67144 0
Turkey
Phone 67144 0
+90 312 5082940
Fax 67144 0
+90 312 5083935
Email 67144 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

Current supporting documents:


Updated to:
Doc. No.TypeCitationLinkEmailOther DetailsAttachment
23444Statistical analysis plan  [email protected]
23445Study protocol  [email protected]
23446Informed consent form  [email protected]
23447Statistical analysis plan  [email protected]
23448Ethical approval  [email protected]
23449Clinical study report  [email protected]

Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.