Cerebral Vascular Accident
Conditions
Keywords
repetitive transcranial magnetic stimulation, stroke, optimal treatment protocol, VR-based cycling training (VCT), randomized controlled trial, motor control, clinical predictors
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.
Interventions
DEVICEiTBS+cTBS group
In iTBS+cTBS pattern, continuous cTBS will be followed by intermittent iTBS (low pulse; 1200 pulses in total)
DEVICEintermittent theta burst stimulation
In intermittent theta burst stimulation pattern (iTBS) will intermittently give a 2 s train of TBS every 10s repeated 2 times for a total of 40 times (low pulse: 1200 pulses in total) Other Names: intermittent theta burst stimulation
In continuous burst stimulation pattern (cTBS) will intermittently give a cTBS treatment consists of a continuous train of TBS for 40 seconds repeated for 2 times(low pulse: 1200 pulses in total). Other Names: continuous burst stimulation
In sham burst stimulation pattern (sham TBS) will intermittently give a sham TBS treatment consists of a continuous train of TBS for 40 seconds(almost no pulse: 1200 pulses in total). Other Names: sham theta burst stimulation
DEVICEVCT
The UE VCT programs were conducted three times per week, for 12 weeks. Each UE VCT session involved upper limb cycling training followed by UE training in addition to home program. The cycling program consisted of a warm-up exercise, twenty repetitions of hand push-up movements in the sitting position, UE cycling, and a cool-down exercise. The warm-up and cool-down exercises involved stretching and relaxing the head, neck, and the upper and lower body. Other Names: The upper extremity programs virtual cycling training program
DEVICEVCT+optimal rTMS group
In VCT+optimal rTMS group, VCT will be combined with optimal rTMS, which has the best outcome in phase 1.
Sponsors
Ministry of Science and Technology, Taiwan
Chang Gung Memorial Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
20 Years to 80 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change from baseline of mechanical measurement for stroke after 3 weeks treatment and 3 months follow-up | baseline, after 3 weeks of treatment, 3 months | Kinematic analysis for upper limb |
| Change from baseline of severity for stroke after 3 weeks treatment and 3 months follow-up | baseline, after 3 weeks of treatment, 3 months | Brunnstrom stage classification(by severity from stage 1 to stage 6), Modified Ashworth Scale (tension of upper limb from min(0) to max (4)) and National Institute of Health Stroke Scale (severity from min(0) to max(4)) |
| Change from baseline of Muscle tone measurement for stroke after 3 weeks treatment and 3 months follow-up | baseline, after 3 weeks of treatment, 3 months | Muscle tone |
| Change from baseline of Muscle strength measurement for stroke after 3 weeks treatment and 3 months follow-up | baseline, after 3 weeks of treatment, 3 months | Muscle strength |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change from baseline of WMFT for stroke in after 3 weeks treatment and 3 months follow-up | baseline, after 3 weeks of treatment, 3 months | Wolf motor function test |
| Change from baseline of MAL for stroke in after 3 weeks treatment and 3 months follow-up | baseline, after 3 weeks of treatment, 3 months | Motor activity log |
| Change from baseline of body composition for stroke in after 3 weeks treatment and 3 months follow-up | baseline, after 3 weeks of treatment, 3 months | InBodyS10 Body Composition Analyzer |
| Change from baseline of FIM for stroke in after 3 weeks treatment and 3 months follow-up | baseline, after 3 weeks of treatment, 3 months | Functional Independence Measure |
| Change from baseline of participation for stroke in after 3 weeks treatment and 3 months follow-up | baseline, after 3 weeks of treatment, 3 months | Nottingham Health Profile |
| Change from baseline of TUG for stroke in after 3 weeks treatment and 3 months follow-up | baseline, after 3 weeks of treatment, 3 months | Timed 'Up & Go' test |
| Change from baseline of activity for stroke in after 3 weeks treatment and 3 months follow-up | baseline, after 3 weeks of treatment, 3 months | Barthel Index |
| Change from baseline of ABAS for stroke in after 3 weeks treatment and 3 months follow-up | baseline, after 3 weeks of treatment, 3 months | Adaptive behavior assessment system |
| Change from baseline of quality of life for stroke in after 3 weeks treatment and 3 months follow-up | baseline, after 3 weeks of treatment, 3 months | Stroke Impact Scale |
Countries
Taiwan
Contacts
Primary ContactChia-Ling Chen, MD, PhD
Outcome results
None listed