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Clinical Trials/NCT05308667
NCT05308667
Completed
N/A

Effects of Intermittent Theta Burst Stimulation in Addition to Constraint-Induced Movement Therapy in Stroke Patients

Istanbul Medeniyet University1 site in 1 country15 target enrollmentJune 2, 2022

Overview

Phase
N/A
Intervention
Not specified
Conditions
Stroke, Ischemic
Sponsor
Istanbul Medeniyet University
Enrollment
15
Locations
1
Primary Endpoint
Wolf-Motor Function Test
Status
Completed
Last Updated
last year

Overview

Brief Summary

In recent studies, it has been reported that intermittent theta-burst stimulation (iTBS) provides additional benefits when applied in adjunct to the rehabilitation in all stages of stroke (acute, subacute, or chronic). In our study, it was aimed to evaluate the effectiveness of iTBS applied in addition to modified constraint-induced movement therapy (mCIMT). By doing so, we intend to increase patient adherence to neurorehabilitation and decrease the cost of rehabilitation.

Registry
clinicaltrials.gov
Start Date
June 2, 2022
End Date
September 15, 2023
Last Updated
last year
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Istanbul Medeniyet University
Responsible Party
Principal Investigator
Principal Investigator

Esma Nur KOLBAŞI

Researcher

Istanbul Medeniyet University

Eligibility Criteria

Inclusion Criteria

  • First time and unilateral stroke
  • 1-12 months after the incident
  • Getting 24 points or more in Mini Mental Status Examination
  • Being able to stand for 2 minutes without any help by using the upper extremity as a support tool when necessary.
  • Being a low-functioning patient according to the CIMT criteria: a) At least 10 degrees of active wrist extension starting from the angle of full flexion, b) 10 degrees of extension at the metacarpophalangeal and inter-phalangeal joints of at least 2 fingers

Exclusion Criteria

  • those who score more than 2.5 points on the Motor Activity Log-28 scale,
  • who have severe pain in the upper extremity (5 and above on the Visual Analogue Scale) and spasticity (3 and above on the Modified Ashworth Scale), which may affect the treatment, and
  • Those who do not have adequate communication skills.
  • Patients who have visual problems

Outcomes

Primary Outcomes

Wolf-Motor Function Test

Time Frame: 45 minutes

It is a new time-based method to evaluate upper extremity performance while providing insight into joint-specific and total limb movements

Fugl-Meyer Assessment-Upper extremity

Time Frame: 30 minutes

The Fugl-Meyer Assessment (FMA) is a stroke-specific, performance-based impairment index. It is designed to assess motor functioning, balance, sensation and pain.

Secondary Outcomes

  • Motor Evoked Potentials (MEPs)(10 minutes)

Study Sites (1)

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