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Trial registered on ANZCTR
Registration number
ACTRN12617000190303
Ethics application status
Approved
Date submitted
9/01/2017
Date registered
3/02/2017
Date last updated
3/02/2017
Type of registration
Retrospectively registered
Titles & IDs
Public title
Functional brain reorganization enhanced by a novel gait training – evidenced by brain connectivity during treadmill walking in chronic stroke
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Scientific title
Functional brain reorganization enhanced by a novel gait training – evidenced by brain connectivity during treadmill walking in chronic stroke
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Secondary ID [1]
290871
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None
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Stroke
301568
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Condition category
Condition code
Physical Medicine / Rehabilitation
301282
301282
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0
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Physiotherapy
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Stroke
301480
301480
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0
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Haemorrhagic
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Stroke
301481
301481
0
0
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Ischaemic
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Subjects in the experimental group received 30 minutes of turning-based treadmill training for 12 sessions in 4 weeks.
a) A rotational treadmill was designed to provide turning-based treadmill training. This treadmill is similar to a regular treadmill except for its circular running motor belt (0.8-m radius), which forces patients to continually turn rather than walk straight. Safety features included front and side handrails around the walking area, a harness connected to an overhead suspension system, and an emergency stop button located on the side handrail. Participants were trained in both directions, with the affected leg as the inner limb for 15 minutes and then as the outer limb for 15 minutes with a 5-minute break in between. After completing the turning-based treadmill training, a 10-minute ambulation training was followed.
b) The training session was performed as individual one-on-one sessions at the study site.
c) During each training session, an experienced physical therapist stood bedside and encouraged participants to walk with large strides and upright posture.
d) As progressively faster speeds are needed to continue challenging the locomotor abilities of individuals with hemiparesis, the treadmill speed, which began as each individual’s comfortable turning speed on level ground, was increased by increments of 0.05 m/s every 5 minutes as tolerated. The criteria for increasing speed was determined by the ability to remain an upright posture and a perceived exertion of “somewhat hard” or lower (ie, a Borg rating of perceived exertion <13).
e) The register of attendance at sessions was checked by physical therapist.
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Intervention code [1]
296818
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Rehabilitation
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Intervention code [2]
296981
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Treatment: Other
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Comparator / control treatment
Subjects in the control group received 30 minutes of regular treadmill training for 12 sessions in 4 weeks.
Other than the type of treadmill, the training protocol was the same as that described for the experimental group. Training speed was initially set at the individual’s comfortable walking speed on level ground and increased by increments of 0.05 m/s every 5 minutes as tolerated. Participants received 30 minutes of regular treadmill training, followed by a 10-minute ambulation training similar to the experimental group.
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Control group
Active
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Outcomes
Primary outcome [1]
300691
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One of the primary outcome is cortico-cortical connectivity during regular treadmill walking. EEG, EMG, and footswitch signals during treadmill walking were simultaneously recorded from Ag/AgCl electrodes using a 40-channel QuickAmp amplifier (32 EEG channels, 4 bipolar channels for EMG and 4 auxiliary channels for footswitch), and Brain Vision Recorder software (Brain Products, Gilching, Germany).
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Assessment method [1]
300691
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Timepoint [1]
300691
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Cortico-cortical connectivity during regular treadmill walking was assessed before intervention and after completing the 12-session training.
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Primary outcome [2]
300872
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Another primary outcome is cortico-muscular connectivity during regular treadmill walking. EEG, EMG, and footswitch signals during treadmill walking were simultaneously recorded from Ag/AgCl electrodes using a 40-channel QuickAmp amplifier (32 EEG channels, 4 bipolar channels for EMG and 4 auxiliary channels for footswitch), and Brain Vision Recorder software (Brain Products, Gilching, Germany).
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Assessment method [2]
300872
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Timepoint [2]
300872
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Cortico-muscular connectivity during regular treadmill walking was assessed before intervention and after completing the 12-session training.
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Secondary outcome [1]
330624
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One of secondary outcome is overground gait speed. The gait performance at comfortable walking speed were obtained from the GAITRite system (CIR system, Inc, Havertown, PS), which contains pressure-sensitive sensors. The walkway was 4.75 m long and 0.9 m wide, and the pressure-sensitive area was 4.30 m long and 0.61 m wide.
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Assessment method [1]
330624
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Timepoint [1]
330624
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Gait performance was assessed before intervention and after completing the 12-session training.
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Secondary outcome [2]
331082
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Another secondary outcome is overground temporal gait symmetry. The gait performance at comfortable walking speed were obtained from the GAITRite system (CIR system, Inc, Havertown, PS), which contains pressure-sensitive sensors. The walkway was 4.75 m long and 0.9 m wide, and the pressure-sensitive area was 4.30 m long and 0.61 m wide.
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Assessment method [2]
331082
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Timepoint [2]
331082
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Gait performance was assessed before intervention and after completing the 12-session training.
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Eligibility
Key inclusion criteria
Participants with stroke had to satisfy the following criteria: (a) 6 months post first-ever stroke with unilateral motor deficits, (b) ability to walk independently for at least 6 m with or without use of walking aids (to ensure they were able to complete the 5-m walk test used in the current study), (c) a Brunnstrom stage of affected lower extremity greater than 3, and (d) a score greater than 24 on the mini-mental state examination (MMSE).
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Minimum age
37
Years
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Maximum age
71
Years
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
Exclusion criteria were (a) unstable medical conditions (eg, deep vein thrombosis, aspiration pneumonia, or superimposed sepsis) and (b) history of other diseases known to interfere with participation in the study (eg, heart failure, hemi-neglect, or diabetic neuropathy).
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
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Who is / are masked / blinded?
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Intervention assignment
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Other design features
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Phase
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Date of first participant enrolment
Anticipated
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Actual
13/09/2011
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Date of last participant enrolment
Anticipated
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Actual
31/05/2013
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Date of last data collection
Anticipated
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Actual
28/06/2013
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Sample size
Target
20
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Accrual to date
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Final
18
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Recruitment outside Australia
Country [1]
8558
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Taiwan, Province Of China
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State/province [1]
8558
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Funding & Sponsors
Funding source category [1]
295299
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Government body
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Name [1]
295299
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National Health Research Institutes of the Republic of China
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Address [1]
295299
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35 Keyan Road, Zhunan, Miaoli County 35053, Taiwan
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Country [1]
295299
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Taiwan, Province Of China
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Primary sponsor type
University
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Name
National Yang Ming University
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Address
No.155, Sec. 2, Linong St., Beitou Dist., Taipei City 112, Taiwan (R.O.C.)
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Country
Taiwan, Province Of China
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Secondary sponsor category [1]
294118
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None
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Name [1]
294118
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Address [1]
294118
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Country [1]
294118
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Ethics approval
Ethics application status
Approved
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Ethics committee name [1]
296632
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Taipei City Hospital
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Ethics committee address [1]
296632
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No.145, Zhengzhou Rd., Datong Dist., Taipei City 10341, Taiwan (R.O.C.)
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Ethics committee country [1]
296632
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Taiwan, Province Of China
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Date submitted for ethics approval [1]
296632
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Approval date [1]
296632
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17/08/2011
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Ethics approval number [1]
296632
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Summary
Brief summary
This was a randomized controlled trial with pre and post assessment study. Subjects in the experimental group received 30 minutes of turning-based treadmill training for 12 sessions in 4 weeks, and subjects in the control group received 30 minutes of regular treadmill training for 12 sessions in 4 weeks. Cortico-cortical connectivity and cortico-muscular connectivity during regular treadmill walking and overground gait performance (speed and temporal symmetry) were assessed before intervention and after completing the 12-session training.
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Trial website
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
71586
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Prof Ray-Yau Wang
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Address
71586
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Department of Physical Therapy and Assistive Technology. No.155, Sec.2, Linong Street, Taipei, 112 Taiwan (ROC)
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Country
71586
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Taiwan, Province Of China
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Phone
71586
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+886928231905
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Fax
71586
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Email
71586
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rywang@ym.edu.tw
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Contact person for public queries
Name
71587
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I-Hsuan Chen
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Address
71587
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Department of Physical Therapy. No.452, Huanqiu Rd. Luzhu Dist., Kaohsiung City 82144 Taiwan (R.O.C.)
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Country
71587
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Taiwan, Province Of China
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Phone
71587
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+886 7-6979374
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Fax
71587
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Email
71587
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ihchen@ms.szmc.edu.tw
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Contact person for scientific queries
Name
71588
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I-Hsuan Chen
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Address
71588
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Department of Physical Therapy. No.452, Huanqiu Rd. Luzhu Dist., Kaohsiung City 82144 Taiwan (R.O.C.)
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Country
71588
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Taiwan, Province Of China
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Phone
71588
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+886 7-6979374
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Fax
71588
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Email
71588
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ihchen@ms.szmc.edu.tw
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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
Novel gait training alters functional brain connectivity during walking in chronic stroke patients: A randomized controlled pilot trial.
2019
https://dx.doi.org/10.1186/s12984-019-0503-2
N.B. These documents automatically identified may not have been verified by the study sponsor.
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