NCT03350087

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).

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
120

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Aug 2016

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2016

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

September 7, 2017

Completed
3 months until next milestone

First Posted

Study publicly available on registry

November 22, 2017

Completed
4.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 11, 2022

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 31, 2022

Completed
Last Updated

August 18, 2020

Status Verified

January 1, 2020

Enrollment Period

5.5 years

First QC Date

September 7, 2017

Last Update Submit

August 17, 2020

Conditions

Cerebral Vascular Accident

Keywords

repetitive transcranial magnetic stimulationstrokeoptimal treatment protocolVR-based cycling training (VCT)randomized controlled trialmotor controlclinical predictors

Outcome Measures

Primary Outcomes (4)

  • Change from baseline of mechanical measurement for stroke after 3 weeks treatment and 3 months follow-up

    Kinematic analysis for upper limb

    baseline, after 3 weeks of treatment, 3 months

  • Change from baseline of severity for stroke after 3 weeks treatment and 3 months follow-up

    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))

    baseline, after 3 weeks of treatment, 3 months

  • Change from baseline of Muscle tone measurement for stroke after 3 weeks treatment and 3 months follow-up

    Muscle tone

    baseline, after 3 weeks of treatment, 3 months

  • Change from baseline of Muscle strength measurement for stroke after 3 weeks treatment and 3 months follow-up

    Muscle strength

    baseline, after 3 weeks of treatment, 3 months

Secondary Outcomes (9)

  • 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

  • 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

  • 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

  • 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

  • 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

  • +4 more secondary outcomes

Study Arms (6)

iTBS group

EXPERIMENTAL

In intermittent theta burst stimulation (iTBS group), they received iTBS (80% of active motor threshold) on affected hemisphere.

Device: intermittent theta burst stimulation

cTBS group

EXPERIMENTAL

In continuous theta burst stimulation (cTBS group), they received cTBS (80% of active motor threshold) on unaffected hemisphere.

Device: continuous theta burst stimulation

iTBS+cTBS group

EXPERIMENTAL

Continuous theta burst stimulation (cTBS group) at first followed by intermittent theta burst stimulation (iTBS group).

Device: iTBS+cTBS group

sham TBS group

SHAM COMPARATOR

In sham theta burst stimulation (sham TBS group), they received sham TBS stimulation.

Device: sham theta burst stimulation

VCT group

EXPERIMENTAL

VCT group received the VCT training in addition to traditional rehabilitation. 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.

Device: VCT

VCT+optimal rTMS group

EXPERIMENTAL

VCT+optimal rTMS group received the VCT training and optimal rTMS in addition to traditional rehabilitation.

Device: VCT+optimal rTMS group

Interventions

intermittent theta burst stimulationDEVICE

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

iTBS group
continuous theta burst stimulationDEVICE

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

cTBS group
iTBS+cTBS groupDEVICE

In iTBS+cTBS pattern, continuous cTBS will be followed by intermittent iTBS (low pulse; 1200 pulses in total)

iTBS+cTBS group
sham theta burst stimulationDEVICE

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

sham TBS group
VCTDEVICE

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

VCT group
VCT+optimal rTMS groupDEVICE

In VCT+optimal rTMS group, VCT will be combined with optimal rTMS, which has the best outcome in phase 1.

VCT+optimal rTMS group

Eligibility Criteria

Age20 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Chang Gung Memorial Hospital

Taoyuan District, 333, Taiwan

RECRUITING

Related Publications (1)

  • 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.

    PMID: 34059090DERIVED

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

Study Officials

  • Chia-Ling Chen, MD, PhD

    Chang Gung Memorial Hospital

    STUDY DIRECTOR

Central Study Contacts

Chia-Ling Chen, MD, PhD

CONTACT

+886-3-3281200clingchen@gmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 7, 2017

First Posted

November 22, 2017

Study Start

August 1, 2016

Primary Completion

February 11, 2022

Study Completion

May 31, 2022

Last Updated

August 18, 2020

Record last verified: 2020-01

Data Sharing

IPD Sharing
Will not share

Locations

TW(1)