Clinical trial NCT03689491: The Combining rTMS With Visual Feedback Training for Patients With Stroke
Official title: Investigating the Effects of Combining rTMS With Visual Feedback Training to Improve Movements in the Paretic Lower Limb and Gait Performance
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Stroke
Keywords: rTMS
visual feedback
gait
Lead sponsor: Taipei Medical University Hospital
Sponsor class: OTHER
First posted: 2018-09-28
Enrollment: 30
Sex: ALL
Minimum age (years): 20
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Change of Motor evoked potential
timeFrame: Change from baseline to 4 weeks
Secondary outcomes:
measure: Chang of Motor Assessment Score
timeFrame: Change from baseline to 4 weeks
measure: Chang of Berg Balance Test
timeFrame: Change from baseline to 4 weeks
measure: Chang of Fugl-Meyer Assessment-Lower Limb section
timeFrame: Change from baseline to 4 weeks
measure: Chang of Modified barthel index
timeFrame: Change from baseline to 4 weeks
measure: Chang of Time Up and Go
timeFrame: Change from baseline to 4 weeks
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: Taipei Medical University Hospital
Study officials:
affiliation: Taipei Medical University Hospital
name: Cheng Hsien-Lin, Master
role: PRINCIPAL_INVESTIGATOR
References: