New Protocols in the Treatment of Upper Limb Dysfunctions of Patients With Stroke.

September 7, 2017 updated by: Chang Gung Memorial Hospital

New Protocols in the Treatment of Upper Limb Dysfunctions of Patients With Stroke: An Evidence of Clinical and Kinematic Studies.

The fundamental goals of early rehabilitation for patients with stroke are: optimizing motor function within each patient's prognostic potential, preventing the development of secondary conditions that impact life-long health, and promoting patient's participation in their lives. In addition to employ clinical measures after treatment, usual outcome measures employed in the intervention studies included movement kinematics (spatio-temporal characteristics of movements). Recent reports have suggested repetitive transcranial magnetic stimulation (rTMS) and BoNTA (BoNTA) improved motor function in patients with stroke. A novel rTMS paradigm, theta burst stimulation (TBS), including intermittent TBS (iTBS) and continuous TBS (cTBS), that modulates human cortical excitability differently. However, there is lack of literatures in verifying the treatment effect by the integration of clinical and kinematic analysis. Until now, there are no conclusive results regarding optimal rTMS protocol, such as stimulating pattern and for patients with stroke. Additionally, few studies investigate the possible clinical characteristics of patients with stroke that may influence the effects of various treatment protocols proposed in this project.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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).

  1. To compare the movement functions and motor control in patients with stroke of different motor severities.
  2. To investigate the immediate and maintaining effects of different protocols in the treatment of upper limb functions.

  3. 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.

  4. 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.
  5. 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

Enrollment (Actual)

80

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Taiwan
      • Taoyuan, Taiwan, 333
        • Chang Gung Memorial Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Age: 20-80 y/o
  • patients with 1st onset cerebral stroke.

Exclusion Criteria:

  • Brain stem or cerebellar stroke
  • Contraindication to MRI, such as metallic implant
  • Contraindication to BoNTA, such as poor controlled epilepsy
  • History of psychiatric disease
  • Received BoNTA injection or surgery in recent six months
  • Severe psychological impairments, such as mental retardation, autism, or severe Communication problems
  • Progressive disorders, such as neurodegenerative disease
  • Active medical disease, such as infection

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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 Names:
  • 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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
baseline, after treatment, 3 months , 6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Chang Gung Memorial Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2012

Primary Completion (Actual)

June 1, 2017

Study Completion (Actual)

June 1, 2017

Study Registration Dates

First Submitted

September 18, 2013

First Submitted That Met QC Criteria

September 18, 2013

First Posted (Estimate)

September 20, 2013

Study Record Updates

Last Update Posted (Actual)

September 11, 2017

Last Update Submitted That Met QC Criteria

September 7, 2017

Last Verified

September 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 100-0012A3

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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