Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12622000266763
Ethics application status
Approved
Date submitted
17/11/2021
Date registered
14/02/2022
Date last updated
17/09/2023
Date data sharing statement initially provided
14/02/2022
Type of registration
Prospectively registered

Titles & IDs
Public title
Clinical and electrophysiological evaluation of the effect of adjuvant peripheral magnetic stimulation in the treatment of post-stroke ankle flexor spasticity-randomized controlled study
Scientific title
Clinical and electrophysiological evaluation of the effect of adjuvant peripheral magnetic stimulation in the treatment of post-stroke ankle flexor spasticity-randomized controlled study
Secondary ID [1] 305497 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Stroke 323886 0
Spasticity 323887 0
Condition category
Condition code
Physical Medicine / Rehabilitation 321396 321396 0 0
Physiotherapy
Stroke 321397 321397 0 0
Ischaemic
Stroke 321398 321398 0 0
Haemorrhagic
Neurological 322231 322231 0 0
Other neurological disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Repetitive peripheric magnetic stimulation (rPMS): rPMS is an innovative and minimal invasive treatment option for spasticity. It is a physical therapy method based on the interaction between a high-intensity electromagnetic field and the human body. Electric current passes through a magnetic coil placed in the applicator and creates magnetic field to stimulate muscles or nerves. In the current literature, there are studies using rPMS in the treatment of spasticity caused by many different diseases such as stroke, multiple sclerosis, spinal cord injury, and cerebral palsy. In this study, we will use rPMS to reduce spasticity and increase functional capacity of patients in the treatment group. The treatment group will receive a session of 10 minutes each, once a day, 5 days a week for 2 weeks. Thus, all patients in the treatment group will receive ten sessions. rPMS will be done with “BTL-6000 Super Inductive System Elite”. rPMS treatment parameters will be adjusted to use stimulus intensity above the motor threshold determined specifically for each patient, as recommended by the company that developed the device in the treatment of spasticity (frequency modulation: 25-150 Hz - alternative current will be used). All sessions will be done individually and face-to-face by a doctor from the Physical Medicine and Rehabilitation (PMR) Department, who does not know from which group the volunteer is from. Interventions will be made in Neurorehabilitation Unit, Department of PMR, Ankara University.
Ten sessions of stretching exercises will be given to all patients, including the control group. Passive stretching exercises will be applied to ankle flexor muscles by a physiotherapist after the rPMS treatment. Each session will last for 15 minutes, and the exercises will be continued once a day, 5 days a week, for 2 weeks. All sessions will be done individually and face to face by the same physiotherapist who is also blind. Interventions will be made in Neurorehabilitation Unit, Department of PMR, Ankara University.
There will be double checklists, one to be used by the doctor and the other to be used by the physiotherapist, to monitor adherence to the intervention.
Intervention code [1] 321901 0
Treatment: Devices
Intervention code [2] 321902 0
Rehabilitation
Comparator / control treatment
Sham Comparator Sham rPMS
Sham-rPMS group will receive passive streecthing exercises plus sham rPMS. They will be taken into the rPMS treatment room and positioned in the same way as the treatment group. Device will not be operated. But the operating sound of the device will be played 10 minutes and the volunteer will hear it. Like treatment group, they will receive a session of 10 minutes each, once a day, 5 days a week for 2 weeks. After this, passive stretching exercises will be applied to ankle flexor muscles by a physiotherapist as same way as active treatment group. Each session will last for 15 minutes, and the exercises will be continued once a day, 5 days a week, for 2 weeks. All sessions will be done individually and face to face by the same physiotherapist who is also blind. Interventions will be made in Neurorehabilitation Unit, Department of PMR, Ankara University.
There will be double checklists, one to be used by the PMR doctor and the other to be used by the physiotherapist, to monitor adherence to the intervention.
Control group
Placebo

Outcomes
Primary outcome [1] 329173 0
Change in muscle tone assessed by modified Ashworth scale.
Timepoint [1] 329173 0
1-At admission, 2-Immediately after first session, 3-After tenth session, 4-Two weeks after last session completed.
Primary outcome [2] 329174 0
Change in velocity dependent component of spasticity assessed by modified Tardieu score.
Timepoint [2] 329174 0
1-At admission, 2-Immediately after first session, 3-After tenth session, 4-Two weeks after last session completed.
Primary outcome [3] 329175 0
Change in H reflex/M response ratio measured by Electroneuromyography
Timepoint [3] 329175 0
1-At admission, 2-Immediately after first session, 3-After tenth session, 4-Two weeks after last session completed.
Secondary outcome [1] 401714 0
change in functional mobility and gait assessed by 6 meter timed walk test

Explanation for query: This test is same as 10-Meter Timed Walk test. The difference is walking distance. It has shown that 6 meter walk test is valid:
Helen S P Lam, Frank W K Lau, Galen K L Chan & Kevin Sykes (2010) The validity and reliability of a 6-Metre Timed Walk for the functional assessment of patients with stroke, Physiotherapy Theory and Practice, 26:4, 251-255, DOI: 10.3109/09593980903015235
Timepoint [1] 401714 0
1-At admission, 2-After tenth session, 3-Two weeks after last session completed.
Secondary outcome [2] 401715 0
Change in functional mobility assessed with Mobility and Stair section of modified Barthel Index.
Timepoint [2] 401715 0
1-At admission, 2-After tenth session, 3-Two weeks after last session completed.

Eligibility
Key inclusion criteria
1) Being diagnosed with stroke according to the definition of the World Health Organization (1989)
2) Being over 18 years old
3) Having a stroke confirmed by Computed Tomography (CT) and Magnetic Resonance Imaging (MRI)
4) Patients with spasticity between 1 and 3 according to the Modified Ashworth Scale (MAS) in the lower extremity plantar flexor muscles
5) Wellness of the patient's general condition after stroke
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1) Patients treated with botulinum toxin, phenol, alcohol injection for spasticity in the last 6 months
2) Patients who have previously undergone antispastic surgery to the treatment area
3) Patients with a change in oral antispastic drug use in the last 6 months
4) Patients with fixed ankle contracture
5) Patients with signs of acute inflammation in the treatment area
6) Patients with bleeding diathesis
7) Patients with implanted devices (cardiac pacemaker, cochlear implant, drug pumps)
8) Patients with vascular problems such as deep vein thrombosis, phlebitis, varicose veins, arterial disease
9) Patients with a history of cancer in the treatment area
10) Pregnancy
11) Patients with metal implants in the treatment area
12) Patients with nonunion fractures at the treatment site

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)
For allocation concealment, randomisation will be done by a computer programme.
(Central randomisation)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a randomisation table created by computer software (i.e. computerised sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s

The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
In the study, when the Modified Ashworth Scale (MAS) was taken as the primary outcome variable and stage 4 patients according to MAS were not included, One unit decrease in MAS was considered significant, and a total of 68 volunteers were planned to be recruited when power analysis was performed with 80% power and 5% margin of error. However, due to the nature of the study, it was planned to include a total of 80 volunteers, with a 15% loss expected.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
1/03/2022
Actual
11/04/2022
Date of last participant enrolment
Anticipated
26/01/2024
Actual
Date of last data collection
Anticipated
2/02/2024
Actual
Sample size
Target
80
Accrual to date
28
Final
Recruitment outside Australia
Country [1] 24182 0
Turkey
State/province [1] 24182 0
Ankara

Funding & Sponsors
Funding source category [1] 309856 0
University
Name [1] 309856 0
Scientific Research Projects Coordination Unit (Bilimsel Arastirma Projeleri Koordinasyon Birimi)
Country [1] 309856 0
Turkey
Primary sponsor type
University
Name
Ankara University
Address
Ankara Üniversitesi Rektörlügü Bilimsel Arastirma Projeleri Koordinasyon Birimi
Emniyet Mahallesi Incitas Sokak Ek Hizmet Binasi A Blok Giris Kat
post code: 06560
Yenimahalle/Ankara-Turkey
Country
Turkey
Secondary sponsor category [1] 310892 0
None
Name [1] 310892 0
Address [1] 310892 0
Country [1] 310892 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 309594 0
Ankara University Medicine Faculty Clinical Research Ethics Committee
Ethics committee address [1] 309594 0
Ankara Üniversitesi Tip Fakültesi Dekanligi
Klinik Arastirmalar Etik Kurulu Birimi Postcode:06230
Altindag/ ANKARA
Ethics committee country [1] 309594 0
Turkey
Date submitted for ethics approval [1] 309594 0
Approval date [1] 309594 0
04/10/2021
Ethics approval number [1] 309594 0
16-680-21

Summary
Brief summary
Spasticity is the most important cause of disability in stroke patients and it interferes with the patient rehabilitation. Spasticity should be appropriately treated because it causes pain postural problems and decrease in the range of movement, gait problems and negative effect on the quality of life. Spasticity cannot be controlled sometimes by available treatment methods (oral drugs and local treatment method-botulinum toxin injection or physical therapy methods). There is a need of new non-invasive treatment methods for the spasticity treatment.
Repetitive peripheral magnetic stimulation (rPMS) is an innovative and minimally invasive treatment option that has been used as a physical therapy agent. It creates a high-intensity electromagnetic field to stimulate muscles or nerves. Unlike electrical stimulation, rPMS can penetrate deeper layers of the muscles. rPMS has been suggested non-invasive, painless, alternative treatment of spasticity. Within the available literature, there are only few studies that investigated the effect of rPMS on spasticity in stroke patients. The standard dose, duration, and the number of sessions of rPMS for the treatment of spasticity has not been clearly determined, yet.
The aim of the study is to clinically and electrophysiologically evaluate the effectiveness of rPMS in lower extremity plantar flexor spasticity in stroke patients.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 114706 0
Prof Sehim Kutlay
Address 114706 0
Hacettepe, Talatpasa Blv No:82
Fiziksel Tip ve Rehabilitasyon ABD
06230 Altindag/Ankara
Country 114706 0
Turkey
Phone 114706 0
+90 312 508 2822
Fax 114706 0
Email 114706 0
sehim.kutlay@gmail.com
Contact person for public queries
Name 114707 0
Dr Huseyin Oguzhan Aslantas
Address 114707 0
Hacettepe, Talatpasa Blv No:82
Fiziksel Tip ve Rehabilitasyon ABD
06230 Altindag/Ankara
Country 114707 0
Turkey
Phone 114707 0
+90 5556150067
Fax 114707 0
Email 114707 0
aslantas_huseyin@hotmail.com
Contact person for scientific queries
Name 114708 0
Dr Huseyin Oguzhan Aslantas
Address 114708 0
Hacettepe, Talatpasa Blv No:82
Fiziksel Tip ve Rehabilitasyon ABD
06230 Altindag/Ankara
Country 114708 0
Turkey
Phone 114708 0
+90 5556150067
Fax 114708 0
Email 114708 0
aslantas_huseyin@hotmail.com

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
individual participant data underlying published results only
When will data be available (start and end dates)?
IPD will be made avaible immediately following publication with no end date determined
Available to whom?
Researchers who provide a methodologically sound proposal
Available for what types of analyses?
For IPD meta-analyses
How or where can data be obtained?
Access subject to approvals by Principal Investigator by e-mail
Principal investigator Sehim Kutlay
e-mail: skutlay@medicine.ankara.edu.tr
alternative e-mail: sehim.kutlay@gmail.com


What supporting documents are/will be available?




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.