New Protocols in the Treatment of Upper Limb Dysfunctions of Patients With Stroke.
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|ClinicalTrials.gov Identifier: NCT01947413|
Recruitment Status : Completed
First Posted : September 20, 2013
Last Update Posted : September 11, 2017
|Condition or disease||Intervention/treatment||Phase|
|Cerebral Vascular Accident||Other: intermittent theta burst stimulation Other: continuous theta burst stimulation Other: sham theta burst stimulation||Not Applicable|
The research program aims at studying patients with stroke the immediate and maintaining effects of new upper-extremity (UE) treatment protocols after brain damage and identifying the possible mechanisms underlying treatment-induced changes in patients with stroke. This research will study new treatment approaches that have been formulated based on principles of integrated central modulation (rTMS) and peripheral modification techniques (BoNTA).
- To compare the movement functions and motor control in patients with stroke of different motor severities.
- To investigate the immediate and maintaining effects of different protocols in the treatment of upper limb functions.
To evaluate motor control and clinical outcomes after different treatment approaches applied in the UE training of patients with stroke. The treatment approaches to be studied will include different protocols. We hypothesize that there will be improvements in movement performance after the treatment and the level of post-treatment performance will differ among the treatments through different reorganization patterns.
3.1 To compare the motor control and clinical outcomes after different treatment approaches.
3.2 To identify the optimal treatment protocol for patients with stroke.
- To investigate the possible predictors of treatment outcome associated with motor severity, movement and participation for each type of treatments. The possible predictors will include brain lesions, and severity. We hypothesize that the proposed prognostic factors will predict treatment outcomes.
- To analyze the association between motor reorganization measured by kinematic study and behavioral improvement in motor severity, movement and participation measured by clinical tools.
Treating motor dysfunction in patients with stroke requires an understanding of the mechanism underlying motor control. Recent reports have suggested BoNTA and rTMS improved motor function in patients with various disorders. However, there are few researches in identifying the optimal rTMS protocol in the treatment of upper limb dysfunctions in patients with stroke. There is lack of literatures in verifying the treatment effect by movement control studies. The current research will offer valuable kinematic data that support neural-motor models proposed to account for motor control problems in these patients. More important, we will identify the new protocol in the treatment of upper limb dysfunctions in patients with stroke through integration of clinical and kinematic measures. We will identify clinical predictors influencing the outcome for different treatment approaches, and analyze the association between motor control and clinical measures involving motor severity, movement and participation. We believe the results of this study will refine services and supports for patients with stroke to meet these goals. This study may potentially provide directions in kinematic measures for future studies on patients with stroke.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||80 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Outcomes Assessor)|
|Official Title:||New Protocols in the Treatment of Upper Limb Dysfunctions of Patients With Stroke: An Evidence of Clinical and Kinematic Studies.|
|Study Start Date :||December 2012|
|Actual Primary Completion Date :||June 2017|
|Actual Study Completion Date :||June 2017|
Experimental: iTBS group
In intermittent theta burst stimulation (iTBS group), they received iTBS (80% of active motor threshold) on affected hemisphere.
Other: intermittent theta burst stimulation
In intermittent theta burst stimulation pattern (iTBS) will intermittently give a 2 s train of TBS every 10s for a total of 20 times (low pulse: 600 pulses in total)
Experimental: cTBS group
In continuous theta burst stimulation (cTBS group), they received cTBS (80% of active motor threshold) on unaffected hemisphere.
Other: continuous 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(low pulse: 600 pulses in total).
Other Name: continuous burst stimulation
Sham Comparator: sham TBS group
In sham theta burst stimulation (sham TBS group), they received sham TBS stimulation.
Other: sham theta 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: 600 pulses in total).
- Change from baseline of Kinematic analysis after 2 weeks treatment and 3 months , 12 months follow up. [ Time Frame: baseline, after treatment, 3 months , 6 months ]Kinematic analysis for upper limb analysis.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01947413
|Chang Gung Memorial Hospital|
|Taoyuan, Taiwan, 333|
|Study Director:||Chia-Ling Chen, PhD||Chang Gung Memorial Hospital|