Clinical trial NCT03042455: Combined Repetitive Transcranial Magnetic Stimulation and Robot-Assisted Upper Arm Training in Subacute Stroke Patients
Official title: Combined Repetitive Transcranial Magnetic Stimulation and Robot-Assisted Upper Arm Training in Subacute Stroke Patients : Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Stroke
Lead sponsor: Yonsei University
Sponsor class: OTHER
First posted: 2017-02-03
Enrollment: 108
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: This study was designed to establish the clinical evidence for effect of Robot-Assisted upper arm training and Repetitive Transcranial Magnetic Stimulation on upper limb function of subacute stroke patients.

* Purpose : to elucidate the effect of Robot-Assisted upper arm training and Repetitive Transcranial Magnetic Stimulation on upper limb function of stroke patients compared to conventional occupational therapy
* Subjects : total 99 patients with stroke whose upper limb functions are impaired
* Intervention : 4 weeks of therapy (5 days per week)
* Studies : upper limb functional assessment (FMA, MFT, WMFT), computerized motion analysis
* Evaluation plan : 1) pre-intervention, 2) post-2 weeks of intervention, 3) post-4 weeks of intervention, 4) 4 weeks after end of intervention


Eligibility criteria: Inclusion Criteria:

* Upper FMA 7-38
* Hemiplegic patients within 6months after stroke onset
* male or female, 20 years older

Exclusion Criteria:

* Patients with cognitive impairment who are unable to comply with protocol-required procedure
* Quadriplegic or double hemiplegic patients
* Patients with musculoskeletal disease, peripheral nerve disease in upper extremity
* Patients with lower motor neuron disease
* Patients who cannot perform rTMS
* Pregnant woman

Primary outcomes:
measure: Fugl-Meyer Assessment (FMA)
timeFrame: 1 minute before the first intervention
measure: Fugl-Meyer Assessment (FMA)
timeFrame: 2 weeks after the first intervention
measure: Fugl-Meyer Assessment (FMA)
timeFrame: 4 weeks after the first intervention
measure: Fugl-Meyer Assessment (FMA)
timeFrame: 4 weeks after the final intervention
Secondary outcomes:
measure: Wolf motor function test
timeFrame: 1 minute before the first intervention
measure: Wolf motor function test
timeFrame: 2 weeks after the first intervention
measure: Wolf motor function test
timeFrame: 4 weeks after the first intervention
measure: Wolf motor function test
timeFrame: 4 weeks after the final intervention
measure: Manual Function test
timeFrame: 1 minute before the first intervention
measure: Manual Function test
timeFrame: 2 weeks after the first intervention
measure: Manual Function test
timeFrame: 4 weeks after the first intervention
measure: Manual Function test
timeFrame: 4 weeks after the final intervention
measure: Kinematic data of computerized 3D motion analysis
timeFrame: 1 minute before the first intervention
measure: Kinematic data of computerized 3D motion analysis
timeFrame: 2 weeks after the first intervention
measure: Kinematic data of computerized 3D motion analysis
timeFrame: 4 weeks after the first intervention
measure: Kinematic data of computerized 3D motion analysis
timeFrame: 4 weeks after the final intervention
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Department of Rehabilitation Medicine, Severance Hospital, Research Institute of Rehabilitation Medicine, Yonsei University College of Medicine
Study officials:
References: