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Trial registered on ANZCTR


Trial ID
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] 291662 0
none
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
stroke 302820 0
Condition category
Condition code
Stroke 302312 302312 0 0
Haemorrhagic
Stroke 302313 302313 0 0
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] 297750 0
Rehabilitation
Intervention code [2] 298033 0
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] 301719 0
gait velocity obtained from the GAITRite system,
Timepoint [1] 301719 0
pre-training, post-training, and 4 weeks follow-up
Secondary outcome [1] 333681 0
gait asymmetry index using formulas proposed by O'Sullivan et al, 2007 and Hsu et al., 2003
Timepoint [1] 333681 0
pre-training, post-training, and 4 weeks follow-up
Secondary outcome [2] 333682 0
electromyography (EMG) of TA during walking
Timepoint [2] 333682 0
pre-training, post-training, and 4 weeks follow-up
Secondary outcome [3] 333683 0
lower extremity motor score of Fugl-Meyer Assessment
Timepoint [3] 333683 0
pre-training, post-training, and 4 weeks follow-up
Secondary outcome [4] 333684 0
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] 333684 0
pre-training, post-training, and 4 weeks follow-up
Secondary outcome [5] 334657 0
electromyography (EMG) of rectus femoris (RF) during walking
Timepoint [5] 334657 0
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
Gender
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
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment outside Australia
Country [1] 8788 0
Taiwan, Province Of China
State/province [1] 8788 0

Funding & Sponsors
Funding source category [1] 296162 0
Government body
Name [1] 296162 0
Ministry of Science and Technology
Address [1] 296162 0
106, Sec. 2, Heping E. Rd., Taipei 10622, Taiwan, R.O.C
Country [1] 296162 0
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] 295065 0
None
Name [1] 295065 0
Address [1] 295065 0
Country [1] 295065 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 297408 0
Institutional Review Board, Taipei Veterans General Hospital
Ethics committee address [1] 297408 0
No.201, Sec. 2, Shipai Rd., Beitou District, Taipei City, Taiwan 11217, R.O.C.
Ethics committee country [1] 297408 0
Taiwan, Province Of China
Date submitted for ethics approval [1] 297408 0
Approval date [1] 297408 0
15/11/2010
Ethics approval number [1] 297408 0

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 73942 0
Prof Ray-yau, Wang
Address 73942 0
Department of Physical Therapy and Assistive Technology, National Yang-Ming University, 112. No. 155, Sec 2, Li Nong St., Shih-Pai, Taipei, Taiwan
Country 73942 0
Taiwan, Province Of China
Phone 73942 0
+886928231905
Fax 73942 0
Email 73942 0
rywang@ym.edu.tw
Contact person for public queries
Name 73943 0
Prof Ray-yau, Wang
Address 73943 0
Department of Physical Therapy and Assistive Technology, National Yang-Ming University, 112. No. 155, Sec 2, Li Nong St., Shih-Pai, Taipei, Taiwan
Country 73943 0
Taiwan, Province Of China
Phone 73943 0
+886928231905
Fax 73943 0
Email 73943 0
rywang@ym.edu.tw
Contact person for scientific queries
Name 73944 0
Prof Ray-yau, Wang
Address 73944 0
Department of Physical Therapy and Assistive Technology, National Yang-Ming University, 112. No. 155, Sec 2, Li Nong St., Shih-Pai, Taipei, Taiwan
Country 73944 0
Taiwan, Province Of China
Phone 73944 0
+886928231905
Fax 73944 0
Email 73944 0
rywang@ym.edu.tw