Clinical trial NCT03350087: Efficacy of rTMS and VCT on Upper Limb Function in Patients With Stroke
Official title: Efficacy of Repetitive Transcranial Magnetic Stimulation and Virtual Cycling Training on Upper Limb Function in Patients With Stroke
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Cerebral Vascular Accident
Keywords: repetitive transcranial magnetic stimulation
stroke
optimal treatment protocol
VR-based cycling training (VCT)
randomized controlled trial
motor control
clinical predictors
Lead sponsor: Chang Gung Memorial Hospital
Sponsor class: OTHER
Collaborators: name: Ministry of Science and Technology, Taiwan
First posted: 2017-11-22
Enrollment: 120
Sex: ALL
Minimum age (years): 20
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Stroke is the major cause of motor impairment and physical disabilities in the adult population. Spasticity and loss of dexterity are the common problems in stroke. Recently, current interventions, such as cycling training, virtual reality (VR) and repetitive transcranial magnetic stimulation (rTMS), were used for the treatment of upper extremity (UE) dysfunction in patients with stroke. However, few studies investigated the effects of the combinations of different treatment strategies using by integrating brain imaging and motor control studies. This project proposes different novel treatment strategies in the treatment of UE dysfunction in patients with stroke: combined inhibitory/facilitatory rTMS, VR-based cycling training (VCT), and combined rTMS and VCT. We hypothesize that the treatment effect of the combined protocol (optimal rTMS protocol and VCT) is more effective than single treatment due to integration of central and peripheral effects. Different treatment protocols will induce different changes in the brain reorganization and motor control, which further improve motor function, activity, participation, and health related quality of life (HRQOL).

Detailed description: This study aims to 1. identify the immediate effects of different treatment protocols in for UE training in these patients through brain image, motor control and clinical measures; 2. to determine the maintaining therapeutic effects; 3. to elucidate the most optimal treatment protocols; 4. to determine the neuro-motor control mechanism underlying clinical improvement; 5. to determine the clinimetric properties of the brain imaging and motor control measure that are responsive and valid for detecting changes after treatment protocol intervention, and 6. to identify clinical predictors influencing the outcome for treatment protocols.

The research will offer valuable motor control biomarkers for outcome prediction and targeting patients who benefit from new protocols. This project is significant for the translational and evidence-based medicine on stroke neurorehabilitation.

Eligibility criteria: Inclusion Criteria:

* first stroke
* chronic stroke (onset \> 3 months)
* unilateral cerebral lesion with hemiparesis or hemiplegia
* age of 20-80 years
* no epileptic spikes on the EEG

Exclusion Criteria:

* brain stem or cerebellum stroke
* epilepsy
* aneurysm
* arteriovenous malformation
* psychiatric disease
* degenerative disease
* severe cognitive and communicative impairment or aphasia
* severe medical disease
* active medical problems
* metal implant in the body
* pregnancy
* poor cooperation with assessments

Primary outcomes:
measure: Change from baseline of mechanical measurement for stroke after 3 weeks treatment and 3 months follow-up
timeFrame: baseline, after 3 weeks of treatment, 3 months
measure: Change from baseline of severity for stroke after 3 weeks treatment and 3 months follow-up
timeFrame: baseline, after 3 weeks of treatment, 3 months
measure: Change from baseline of Muscle tone measurement for stroke after 3 weeks treatment and 3 months follow-up
timeFrame: baseline, after 3 weeks of treatment, 3 months
measure: Change from baseline of Muscle strength measurement for stroke after 3 weeks treatment and 3 months follow-up
timeFrame: baseline, after 3 weeks of treatment, 3 months
Secondary outcomes:
measure: Change from baseline of body composition for stroke in after 3 weeks treatment and 3 months follow-up
timeFrame: baseline, after 3 weeks of treatment, 3 months
measure: Change from baseline of activity for stroke in after 3 weeks treatment and 3 months follow-up
timeFrame: baseline, after 3 weeks of treatment, 3 months
measure: Change from baseline of ABAS for stroke in after 3 weeks treatment and 3 months follow-up
timeFrame: baseline, after 3 weeks of treatment, 3 months
measure: Change from baseline of quality of life for stroke in after 3 weeks treatment and 3 months follow-up
timeFrame: baseline, after 3 weeks of treatment, 3 months
measure: Change from baseline of WMFT for stroke in after 3 weeks treatment and 3 months follow-up
timeFrame: baseline, after 3 weeks of treatment, 3 months
measure: Change from baseline of MAL for stroke in after 3 weeks treatment and 3 months follow-up
timeFrame: baseline, after 3 weeks of treatment, 3 months
measure: Change from baseline of TUG for stroke in after 3 weeks treatment and 3 months follow-up
timeFrame: baseline, after 3 weeks of treatment, 3 months
measure: Change from baseline of FIM for stroke in after 3 weeks treatment and 3 months follow-up
timeFrame: baseline, after 3 weeks of treatment, 3 months
measure: Change from baseline of participation for stroke in after 3 weeks treatment and 3 months follow-up
timeFrame: baseline, after 3 weeks of treatment, 3 months
Other outcomes:
Locations:
city: Taoyuan
country: Taiwan
facility: Chang Gung Memorial Hospital
Study officials:
affiliation: Chang Gung Memorial Hospital
name: Chia-Ling Chen, MD, PhD
role: STUDY_DIRECTOR
References:
citation: Chen YH, Chen CL, Huang YZ, Chen HC, Chen CY, Wu CY, Lin KC. Augmented efficacy of intermittent theta burst stimulation on the virtual reality-based cycling training for upper limb function in patients with stroke: a double-blinded, randomized controlled trial. J Neuroeng Rehabil. 2021 May 31;18(1):91. doi: 10.1186/s12984-021-00885-5.