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Trial registered on ANZCTR

Registration number

ACTRN12617000717358

Ethics application status

Approved

Date submitted

12/04/2017

Date registered

17/05/2017

Date last updated

17/05/2017

Type of registration

Retrospectively registered

Titles & IDs

Public title

Effects of combining repetitive transcranial magnetic stimulation with treadmill training on gait performance in individuals with chronic stroke

Scientific title

Effects of combining repetitive transcranial magnetic stimulation with treadmill training on gait performance in individuals with chronic stroke

Secondary ID [1]

none

Universal Trial Number (UTN)

Trial acronym

Linked study record

Health condition

Health condition(s) or problem(s) studied:

stroke

Condition category

Condition code

Stroke

Haemorrhagic

Stroke

Ischaemic

Intervention/exposure

Study type

Interventional

Description of intervention(s) / exposure

Fourteen participants with chronic stroke were randomly assigned to experimental (n=8) or control group (n=6). Participants in both groups received treadmill training for 30 minitues, 3 times a week for 3 weeks. The treadmill training started with a 5 minutes warm up session walking at half of participant’s preferred speed. After warm up, the treadmill speed would be increased gradually until the maximum tolerable and safe speed of the participant has been reached. While training, a suspension system was used to ensure the safety of the participants, and a physiotherapist would be standing aside to ensure that the participants walked with good posture and appropriate weight transfer using verbal cues.

Prior to each treadmill training session, the participants in the experimental group received real repetitive transcranial magnetic stimulation (rTMS) with 5Hz, 10s, 18 trains with total 900 pulses at 90% resting motor threshold for 15 minutes to the ipsilesional primary motor cortex of tibialis anterior (TA) muscle, and the control group received sham rTMS.

Intervention code [1]

Rehabilitation

Intervention code [2]

Treatment: Other

Comparator / control treatment

the control group received sham rTMS plus same treadmill training as experimental group

Control group

Active

Outcomes

Primary outcome [1]

gait velocity obtained from the GAITRite system,

Timepoint [1]

pre-training, post-training, and 4 weeks follow-up

Secondary outcome [1]

gait asymmetry index using formulas proposed by O'Sullivan et al, 2007 and Hsu et al., 2003

Timepoint [1]

pre-training, post-training, and 4 weeks follow-up

Secondary outcome [2]

electromyography (EMG) of TA during walking

Timepoint [2]

pre-training, post-training, and 4 weeks follow-up

Secondary outcome [3]

lower extremity motor score of Fugl-Meyer Assessment

Timepoint [3]

pre-training, post-training, and 4 weeks follow-up

Secondary outcome [4]

brain motor evoked potential (MEP) asymmetry calculated by using amplitude of MEP of both hemispheres obtained from MagStim 200 and the formula built by Brouwer et al., 2006.

Timepoint [4]

pre-training, post-training, and 4 weeks follow-up

Secondary outcome [5]

electromyography (EMG) of rectus femoris (RF) during walking

Timepoint [5]

pre-training, post-training, and 4 weeks follow-up

Eligibility

Key inclusion criteria

(1) hemiparesis from a single stroke, (2) after stroke period more than 6 month. (3)able to walk independently for 10 meters with or without an assistive device. (4) Stable medical condition to allow participation in the testing protocol

Minimum age

20 Years

Maximum age

80 Years

Sex

Both males and females

Can healthy volunteers participate?

No

Key exclusion criteria

(1) subjects have contraindications of TMS, such as: intracranial metal implants, history of epilepsy or severe heart disease; (2) other non-stroke-related neurological diseases, Such as: cerebellum or vestibular system disease; (3) cognitive dysfunction; (4) muscular system diseases of lower limbs and interfere the walking function.

Study design

Purpose of the study

Treatment

Allocation to intervention

Randomised controlled trial

Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)

Methods used to generate the sequence in which subjects will be randomised (sequence generation)

Masking / blinding

Who is / are masked / blinded?

Intervention assignment

Other design features

Phase

Type of endpoint/s

Statistical methods / analysis

Recruitment

Recruitment status

Stopped early

Data analysis

Data collected is being analysed

Reason for early stopping/withdrawal

Participant recruitment difficulties

Date of first participant enrolment

Anticipated

Actual

22/12/2010

Date of last participant enrolment

Anticipated

Actual

17/05/2011

Date of last data collection

Anticipated

Actual

5/07/2011

Sample size

Target

30

Accrual to date

Final

14

Recruitment outside Australia

Country [1]

Taiwan, Province Of China

State/province [1]

Funding & Sponsors

Funding source category [1]

Government body

Name [1]

Ministry of Science and Technology

Address [1]

106, Sec. 2, Heping E. Rd., Taipei 10622, Taiwan, R.O.C

Country [1]

Taiwan, Province Of China

Primary sponsor type

Individual

Name

Ray-yau, Wang

Address

Department of Physical Therapy and Assistive Technology, National Yang-Ming University, 112. No. 155, Sec 2, Li Nong St., Shih-Pai, Taipei, Taiwan

Country

Taiwan, Province Of China

Secondary sponsor category [1]

None

Name [1]

Address [1]

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Institutional Review Board, Taipei Veterans General Hospital

Ethics committee address [1]

No.201, Sec. 2, Shipai Rd., Beitou District, Taipei City, Taiwan 11217, R.O.C.

Ethics committee country [1]

Taiwan, Province Of China

Date submitted for ethics approval [1]

Approval date [1]

15/11/2010

Ethics approval number [1]

Summary

Brief summary

Background and purpose: Decreased gait performance is one of the functional limitations after stroke. It’s important to establish effective rehabilitation strategies to restore walking function. Repetitive transcranial magnetic stimulation (rTMS) can modulate the excitability of the motor cortex. Some studies showed that combining rTMS with motor training resulted in better improvements in hand function than motor training alone. However, such effects on lower extremity have not been established. The purpose of this study was to investigate effects of combining rTMS with treadmill training on gait performance in chronic stroke patients. Methods: This is a double-blinded randomized control trial. Fourteen participants with chronic stroke were randomly assigned to experimental (n=8) or control group (n=6). Participants in both groups received treadmill training for 30 minitues, 3 times a week for 3 weeks. Before treadmill training, the participants in the experimental group received real rTMS with 5Hz, 10s, 18 trains with total 900 pulses at 90% resting motor threshold for 15 minutes to the ipsilesional primary motor cortex of tibialis anterior (TA) muscle, and the control group received sham rTMS. The outcome measures were collected at pre-training, post-training, and 4 weeks follow-up, including gait velocity, spatial and temporal gait asymmetry index, and electromyography (EMG) of TA and rectus femoris (RF) during walking, lower extremity motor score of Fugl-Meyer Assessment , amplitude of motor evoked potential (MEP)for both hemispheres and brain MEP asymmetry. Friedman test was used to exam within-group improvement at different time points, Mann-Whitney U test was used to exam the differences between groups, and the significant level was set at a=0.05.

Trial website

Trial related presentations / publications

Public notes

Contacts

Principal investigator

Name

Prof Ray-yau, Wang

Address

Department of Physical Therapy and Assistive Technology, National Yang-Ming University, 112. No. 155, Sec 2, Li Nong St., Shih-Pai, Taipei, Taiwan

Country

Taiwan, Province Of China

Phone

+886928231905

Fax

Email

rywang@ym.edu.tw

Contact person for public queries

Name

Ray-yau, Wang

Address

Department of Physical Therapy and Assistive Technology, National Yang-Ming University, 112. No. 155, Sec 2, Li Nong St., Shih-Pai, Taipei, Taiwan

Country

Taiwan, Province Of China

Phone

+886928231905

Fax

Email

rywang@ym.edu.tw

Contact person for scientific queries

Name

Ray-yau, Wang

Address

Department of Physical Therapy and Assistive Technology, National Yang-Ming University, 112. No. 155, Sec 2, Li Nong St., Shih-Pai, Taipei, Taiwan

Country

Taiwan, Province Of China

Phone

+886928231905

Fax

Email

rywang@ym.edu.tw

No information has been provided regarding IPD availability

What supporting documents are/will be available?

No Supporting Document Provided

Results publications and other study-related documents

Documents added manually

No documents have been uploaded by study researchers.

Documents added automatically

Source	Title	Year of Publication	DOI
Embase	High-frequency repetitive transcranial magnetic stimulation enhanced treadmill training effects on gait performance in individuals with chronic stroke: A double-blinded randomized controlled pilot trial.	2019	https://dx.doi.org/10.1016/j.gaitpost.2018.12.023

N.B. These documents automatically identified may not have been verified by the study sponsor.