The Combining rTMS With Visual Feedback Training for Patients With Stroke

Not Applicable

Completed

• Conditions: Stroke
• Interventions: Behavioral: rTMS; Behavioral: visual feedback training; Behavioral: traditional rehabilitation

• Registration Number: NCT03689491
• Lead Sponsor: Taipei Medical University Hospital

Brief Summary

After stroke, patients often experience motor deficits that interrupt normal lower extremity movement and gait function. Recent developments in neuroimaging have focus on the reasons why some patients recover well while some do poorly. However, there is still no consensus on the exact mechanisms involved in regaining the functions after rehabilitation. Application of repetitive transcranial magnetic stimulation (rTMS) to facilitate neural plasticity during stroke treatment has recently gained considerable attention. The possible mechanism through which rTMS acts is based on the interhemispheric competition (IHC) model, which explains that patients with stroke experience alterations in cortical excitability and exhibit abnormally high interhemispheric inhibition from the unaffected hemisphere to the affected hemisphere. The visual feedback training can improve postural control and enhance motor performance. Several rTMS studies have evaluated the lower extremity dysfunction following stroke, but few studies have explored the efficacy of applying rTMS on the lower extremities. We expect the study can help us to further exploration of the change of clinical function and cortical excitability following rTMS and visual feedback training in subjects with stroke. In addition, the results of this project will be provided for further rehabilitation programs in people with stroke.

Detailed Description

Objective: To investigate the effects of combining rTMS with visual feedback training to improve movements in the paretic lower limb and gait performance.

Methods: Thirty patients with monohemispheric after ischemic stroke will recruited and randomized into 3 groups. The group 1 received a 10-minute rTMS intervention then a 30-minute visual feedback training. The group 2 received a 10-minute sham rTMS intervention then a 30-minute visual feedback training. The group 3 received a 10-minute sham rTMS intervention then a 30-minute traditional rehabilitation training. All subjects received treatments 3 times a week for 4 weeks. The performance was assessed by a blinded assessor for two times (baseline and after 4 weeks). The outcome measures included Motor evoked potential (MEP), Fugl-Meyer Assessment-Lower Limb section(FMA-LE),Motor Assessment Score(MAS), Berg Balance Test (BBS),Time Up and Go (TUG), and Modified Barthel Index for ADL ability. Collected data will be analyzed with ANOVA test by SPSS version 20.0, and alpha level was set at 0.05. The hypothesis is combining rTMS with visual feedback training has positive effects on lower limb and gait performance among patients with stroke.

Study Timeline

• Study Start: 2017-01-05
• Status Verified: 2018-09
• Study First Submitted: 2018-09-27
• Study First Submitted QC: 2018-09-27
• Study First Posted: 2018-09-28
• Primary Completion: 2019-06-30
• Study Completion: 2019-07-31
• Last Update Submitted: 2023-01-15
• Last Update Posted: 2023-01-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

1. Monohemispheric ischemic or hemorrhage stroke
2. Subjects with first-ever stroke 3.6 months after stroke onset

4.The Brunnstrom stage of lower limb >Ⅲ 5.>23 in the mini-mental state exam 6.The Modified Ashworth Scale of lower limb <3 7.Clear consciousness can meet the relevant assessments

Exclusion Criteria

1. Recurrent stoke
2. Severe spasticity of lower limb and difficult to perform isolative movement.
3. History of seizures or epileptic
4. Have implanted ferromagnetic devices or other magnetic-sensitive metal implants
5. Concomitant vestibular and cerebellum diseases
6. Joint contracture of lower limb/foot and other orthopedic problems
7. Subjects with severe cognitive impairment
8. Subjects with depression and/or mood disorder
9. Presence of any comorbid neurological diseases or psychological diseases

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
sham rTMS+visual feedback	visual feedback training	10-minute sham rTMS and then a 30-minute visual feedback training ,3 times a week, for 4 weeks
rTMS+visual feedback	rTMS	10-minute rTMS and then a 30-minute visual feedback training ,3 times a week, for 4 weeks
rTMS+visual feedback	visual feedback training	10-minute rTMS and then a 30-minute visual feedback training ,3 times a week, for 4 weeks
sham rTMS+traditional training	traditional rehabilitation	10-minute sham rTMS and then a 30-minute traditional rehabilitation training,3 times a week, for 4 weeks
sham rTMS+visual feedback	rTMS	10-minute sham rTMS and then a 30-minute visual feedback training ,3 times a week, for 4 weeks
sham rTMS+traditional training	rTMS	10-minute sham rTMS and then a 30-minute traditional rehabilitation training,3 times a week, for 4 weeks

Primary Outcome Measures

Name	Time	Method
Change of Motor evoked potential	Change from baseline to 4 weeks	Measurement of motor evoked potential of anterior tibialis

Secondary Outcome Measures

Name	Time	Method
Chang of Time Up and Go	Change from baseline to 4 weeks	functional ambulation
Chang of Fugl-Meyer Assessment-Lower Limb section	Change from baseline to 4 weeks	Lower Limb section
Chang of Modified barthel index	Change from baseline to 4 weeks	Activity of daily live ability
Chang of Motor Assessment Score	Change from baseline to 4 weeks	Lower Limb motor function
Chang of Berg Balance Test	Change from baseline to 4 weeks	standing balance

Trial Locations

Locations (1)

Taipei Medical University Hospital; 🇨🇳 Taipei, Taiwan