Clinical and electrophysiological evaluation of the effect of adjuvant peripheral magnetic stimulation in the treatment of post-stroke ankle flexor spasticity-randomized controlled study

Not Applicable

Recruiting

• Conditions: Stroke; Spasticity; Physical Medicine / Rehabilitation - Physiotherapy; Stroke - Ischaemic; Stroke - Haemorrhagic; Neurological - Other neurological disorders

• Registration Number: ACTRN12622000266763
• Lead Sponsor: Ankara University

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2022-02-14
• Last Update Posted: 26 September 2023

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 80

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

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

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Change in muscle tone assessed by modified Ashworth scale.[ 1-At admission, 2-Immediately after first session, 3-After tenth session, 4-Two weeks after last session completed.];Change in velocity dependent component of spasticity assessed by modified Tardieu score.[ 1-At admission, 2-Immediately after first session, 3-After tenth session, 4-Two weeks after last session completed.];Change in H reflex/M response ratio measured by Electroneuromyography[ 1-At admission, 2-Immediately after first session, 3-After tenth session, 4-Two weeks after last session completed.]

Secondary Outcome Measures

Name	Time	Method
change in functional mobility and gait assessed by 6 meter timed walk test<br><br>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: <br>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[ 1-At admission, 2-After tenth session, 3-Two weeks after last session completed.];Change in functional mobility assessed with Mobility and Stair section of modified Barthel Index.[ 1-At admission, 2-After tenth session, 3-Two weeks after last session completed.]