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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
Scientific title
Functional brain reorganization enhanced by a novel gait training – evidenced by brain connectivity during treadmill walking in chronic stroke
Secondary ID [1] 290871 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Stroke 301568 0
Condition category
Condition code
Physical Medicine / Rehabilitation 301282 301282 0 0
Physiotherapy
Stroke 301480 301480 0 0
Haemorrhagic
Stroke 301481 301481 0 0
Ischaemic

Intervention/exposure
Study type
Interventional
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.

Intervention code [1] 296818 0
Rehabilitation
Intervention code [2] 296981 0
Treatment: Other
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.
Control group
Active

Outcomes
Primary outcome [1] 300691 0
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).
Timepoint [1] 300691 0
Cortico-cortical connectivity during regular treadmill walking was assessed before intervention and after completing the 12-session training.
Primary outcome [2] 300872 0
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).
Timepoint [2] 300872 0
Cortico-muscular connectivity during regular treadmill walking was assessed before intervention and after completing the 12-session training.
Secondary outcome [1] 330624 0
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.
Timepoint [1] 330624 0
Gait performance was assessed before intervention and after completing the 12-session training.
Secondary outcome [2] 331082 0
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.
Timepoint [2] 331082 0
Gait performance was assessed before intervention and after completing the 12-session training.

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).
Minimum age
37 Years
Maximum age
71 Years
Gender
Both males and females
Can healthy volunteers participate?
No
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).

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
Completed
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] 8558 0
Taiwan, Province Of China
State/province [1] 8558 0

Funding & Sponsors
Funding source category [1] 295299 0
Government body
Name [1] 295299 0
National Health Research Institutes of the Republic of China
Address [1] 295299 0
35 Keyan Road, Zhunan, Miaoli County 35053, Taiwan
Country [1] 295299 0
Taiwan, Province Of China
Primary sponsor type
University
Name
National Yang Ming University
Address
No.155, Sec. 2, Linong St., Beitou Dist., Taipei City 112, Taiwan (R.O.C.)
Country
Taiwan, Province Of China
Secondary sponsor category [1] 294118 0
None
Name [1] 294118 0
Address [1] 294118 0
Country [1] 294118 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 296632 0
Taipei City Hospital
Ethics committee address [1] 296632 0
No.145, Zhengzhou Rd., Datong Dist., Taipei City 10341, Taiwan (R.O.C.)
Ethics committee country [1] 296632 0
Taiwan, Province Of China
Date submitted for ethics approval [1] 296632 0
Approval date [1] 296632 0
17/08/2011
Ethics approval number [1] 296632 0

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.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 71586 0
Prof Ray-Yau Wang
Address 71586 0
Department of Physical Therapy and Assistive Technology. No.155, Sec.2, Linong Street, Taipei, 112 Taiwan (ROC)
Country 71586 0
Taiwan, Province Of China
Phone 71586 0
+886928231905
Fax 71586 0
Email 71586 0
rywang@ym.edu.tw
Contact person for public queries
Name 71587 0
Mrs I-Hsuan Chen
Address 71587 0
Department of Physical Therapy. No.452, Huanqiu Rd. Luzhu Dist., Kaohsiung City 82144 Taiwan (R.O.C.)
Country 71587 0
Taiwan, Province Of China
Phone 71587 0
+886 7-6979374
Fax 71587 0
Email 71587 0
ihchen@ms.szmc.edu.tw
Contact person for scientific queries
Name 71588 0
Mrs I-Hsuan Chen
Address 71588 0
Department of Physical Therapy. No.452, Huanqiu Rd. Luzhu Dist., Kaohsiung City 82144 Taiwan (R.O.C.)
Country 71588 0
Taiwan, Province Of China
Phone 71588 0
+886 7-6979374
Fax 71588 0
Email 71588 0
ihchen@ms.szmc.edu.tw

No information has been provided regarding IPD availability
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary