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Trial registered on ANZCTR


Registration number
ACTRN12616001296426
Ethics application status
Approved
Date submitted
2/05/2016
Date registered
14/09/2016
Date last updated
14/09/2016
Type of registration
Retrospectively registered

Titles & IDs
Public title
The effects of reverse pedaling training on stiff knee gait pattern and Electromyography (EMG) – Electroencephalogram (EEG) coherence of lower extremity in patients with stroke
Scientific title
The effects of reverse pedaling training on stiff knee gait pattern and Electromyography (EMG) – Electroencephalogram (EEG) coherence of lower extremity in patients with stroke
Secondary ID [1] 289123 0
none
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
stroke 298600 0
Condition category
Condition code
Physical Medicine / Rehabilitation 298670 298670 0 0
Physiotherapy
Stroke 298854 298854 0 0
Ischaemic
Stroke 299064 299064 0 0
Haemorrhagic

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
In the first part of the study, 20 healthy participants only receive once assessment that includes pedaling test and walking test.
The pedaling test includes two directions (forward and backward) combine three kinds of revolution (30, 45, 60 RPM).
Each direction combines one type revolution will ride 60 seconds, total perform three times.
Healthy participants do not receive any bicycle training or conventional physical therapy.

In the second part of the study, 20 stroke patients only receive once assessment that includes clinical assessment, pedaling test and walking test.
The clinical assessment includes Brunnstrom assessment of lower extremity, Fugl-Meyer assessment of lower extremity, 5 repetitions sit to stand test, and Time Up and Go Test.
The pedaling test includes two directions (forward and backward) combine 45 RPM. Each direction combines 45RPM will ride 60 seconds, total perform three times.
Subjects in this part, they do not receive any bicycle training or conventional physical therapy.

In the third part of the study, we will recruit 40 stroke patients.
They will be randomly assigned to forward pedaling group (FW) or backward pedaling group (BW).
We will use bicycle training combine traditional physical therapy for intervention.
Before and after 4 weeks intervention, they will accept separately an assessment.
The assessment is including clinical evaluation, pedaling test and walking test.

Forward pedaling training will be treated as a control group. Backward pedaling is the intervention being assessed. The results of BW pedaling group will be compared with FW group.
Each intervention includes 30mins FW or BW pedaling training combine 45RPM (30-minute intervention includes 5mins warm up and 5mins cool down) and traditional physical therapy 20mins.
The intervention will be executive 3 times per week, total 4 weeks.
Traditional physical therapy focuses on weight shifting, affected side lower limb weight bearing and walking practice.

This study carried out by physiotherapists in the physical therapy laboratory at National Yang-Ming University. (The physiotherapist must have at least 2 years of clinical experience and qualified physiotherapist.) We will provide individually and face to face training.
Intervention code [1] 294627 0
Rehabilitation
Comparator / control treatment
This will be a three-phase research project to investigate.
In first part, 20 healthy adults’ data will be a base of reference to screen the patient who has stiff knee gait problem.

In second part, we will compare the differences of pedaling test results in FW and BW pedaling direction with 45 RPM between the healthy adults and stroke patients.

In third part study, we will compare the results of pre and post intervention differences. The data include clinical assessments, pedaling test and walking test between forward and backward pedaling training groups.
Control group
Active

Outcomes
Primary outcome [1] 298163 0
Range of motion of bilateral knee joint during walking testing will be assessed by electronic goniometer.
Timepoint [1] 298163 0
1) Once assessment in health adults (control group).
2) Once assessment in stroke patients (in second part study).
3) Before and after 4 weeks intervention, we will get primary outcome in experimental group.(the stroke patients of phase three study)
Primary outcome [2] 298331 0
To calculate EEG-EMG correlation to indicate neuro-muscular coherence during 45rpm forward and backward pedaling testing by QuickAmp system.
21 channels EEG signals. Include primary motor cortex (Cz, C1,C2,C3,C4,C5,C6), premotor cortex (FC3,FC4,FC5,FC6), supplementary motor area( FCz,FC1,FC2), and somatosensory cortex (CPz,CP1,CP2,CP3,CP4,CP5,CP6) and sEMG signals from 6 muscles of bilateral lower limb Include bilateral Rectus Femoris, Biceps Femoris and Gastrocnemius medialis muscles.
Timepoint [2] 298331 0
1) Once assessment in health adults (control group).
2) Once assessment in stroke patients (in second part study).
3) Before and after 4 weeks intervention, we will get primary outcome in experimental group.(the stroke patients of phase three study)
Primary outcome [3] 298332 0
We will collect bilateral rectus femoris and hamstrings surface EMG signals during walking testing by Biopec system. We utilize foot switch to cut out the standing phase and swing phase in a gait cycle, then calculate bilateral hamstring and rectus femoris muscles activation condition.
Timepoint [3] 298332 0
1) Once assessment in health adults (control group).
2) Before and after 4 weeks intervention, we will get primary outcome in experimental group.(the stroke patients of phase three study)
Secondary outcome [1] 323324 0
We will evaluate gait parameters by GaitRite system.
Timepoint [1] 323324 0
1) Once assessment in health adults (control group).
2) Before and after 4 weeks intervention, we will get secondary outcome in experimental group.(the stroke patients of phase three study)
Secondary outcome [2] 323868 0
Clinical assessment-1:
Lower extremity stroke symptom severity will be assessed by the Brunnstrom assessment of lower extremity.
Timepoint [2] 323868 0
Before and after 4 weeks intervention, we will get secondary outcome in experimental group.(the stroke patients of phase three study)
Secondary outcome [3] 323869 0
Clinical assessment-2:
Motor function in legs will be assessed by the Fugl-Meyer assessment of lower extremity.
Timepoint [3] 323869 0
Before and after 4 weeks intervention, we will get secondary outcome in experimental group.(the stroke patients of phase three study)
Secondary outcome [4] 323870 0
Clinical assessment-3:
Muscle power in legs will be assessed by the 5 repetitions sit to stand test.
Timepoint [4] 323870 0
Before and after 4 weeks intervention, we will get secondary outcome in experimental group.(the stroke patients of phase three study)
Secondary outcome [5] 323871 0
Clinical assessment-4:
Walking speed and risk of falling will be assessed by Time Up and Go Test.
Timepoint [5] 323871 0
Before and after 4 weeks intervention, we will get secondary outcome in experimental group.(the stroke patients of phase three study)

Eligibility
Key inclusion criteria
20 participants in control group met the following inclusion criteria: (1) age between the 40 to 65 years old; (2) could tolerate sitting on a bicycle seat at least one hour and complete the pedaling activity; (3) no other orthopedics or cardiovascular disease that could prohibit the bicycle exercise execution; (4)no epilepsy or take epileptic drugs last six months.

20 stroke participants in the assessment only group and 40 participants in the experimental group are met the following inclusion criteria: (1) age between the 40 to 65 years old; (2) Hemisphere stroke more than 6 months with hemiplegia; (3) Lower extremity Brunnstrom motor recovery stage at 3-4 (focus on still have stiff knee problem); (4) must comply with Stiff-knee gait screening criteria; (5) Can able to walk >3 m with or without a walking aid or orthosis; (6) could tolerate sitting on a bicycle seat at least one hour and complete the pedaling activity; (7) no other orthopedics or cardiovascular disease that could prohibit the bicycle exercise execution; (8) Mini-Mental State Examination equal or more than 24, can to obey the orders; (9) no epilepsy or take epileptic drugs last six months.
Minimum age
40 Years
Maximum age
65 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
if they have other orthopedics or cardiovascular disease
if they have epilepsy or take epileptic drugs last six months

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
Using an effect size d of 0.8, a type I error of 0.05, a 69% power, at least 20 patients in each group were required for identifying statistically significant differences in EEG-EMG coherence and walking performance (ANOVA).

20 healthy adults and 60 stroke patients will be recruited.
Descriptive statistics will be used to describe subjects’ demographic data. All data will be shown by mean and SD.

Analysis of variance (ANOVA) will be used to compare the EEG-EMG coherence data in two directions with three kinds of pedaling revolution within FP and BP in control group. ANOVA will also be used to compare the measured parameters included the clinical assessment results and walking assessment data (gait performance, bilateral lower extremity EMG data and ROM of knee joint during walking) in FP and BP group of stroke patients between before and after treatment. At the same time, ANOVA will also be used to compare the measured parameters included walking assessment results, EEG-EMG coherence in FP and BP with 45rpm between control group and experimental group before and after training.

All data will be analyzing using SPSS 20 statistical software. The significant level was set at p<0.05.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
2/04/2016
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
80
Accrual to date
Final
Recruitment outside Australia
Country [1] 7847 0
Taiwan, Province Of China
State/province [1] 7847 0
Taipei city

Funding & Sponsors
Funding source category [1] 293492 0
University
Name [1] 293492 0
National Yang-Ming University
Country [1] 293492 0
Taiwan, Province Of China
Primary sponsor type
University
Name
National Yang-Ming University
Address
No.155, Sec.2, Linong Street, Taipei, 112 Taiwan (ROC)
Country
Taiwan, Province Of China
Secondary sponsor category [1] 292318 0
Hospital
Name [1] 292318 0
Taipei Veterans General Hospital
Address [1] 292318 0
No.201, Sec. 2, Shipai Rd., Beitou District, Taipei City, Taiwan 11217, R.O.C.
Country [1] 292318 0
Taiwan, Province Of China

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 294936 0
Institutional Review Board of Taipei Veterans General Hospital
Ethics committee address [1] 294936 0
Ethics committee country [1] 294936 0
Taiwan, Province Of China
Date submitted for ethics approval [1] 294936 0
05/10/2015
Approval date [1] 294936 0
21/01/2016
Ethics approval number [1] 294936 0
2015-11-003C

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 65550 0
Miss Shu-Shyuan Hsu
Address 65550 0
Department of Physical Medicine and Rehabilitation. Taipei Veterans General Hospital.
No.201, Sec. 2, Shipai Rd., Beitou District, Taipei City, Taiwan 11217, R.O.C.
Country 65550 0
Taiwan, Province Of China
Phone 65550 0
+886-2-2875-7808
Fax 65550 0
+886-2-2875-7858
Email 65550 0
sssheu@vghtpe.gov.tw
Contact person for public queries
Name 65551 0
Yea-Ru Yang
Address 65551 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 65551 0
Taiwan, Province Of China
Phone 65551 0
+886-2-2821-0271
Fax 65551 0
Email 65551 0
yryang@ym.edu.tw
Contact person for scientific queries
Name 65552 0
Yea-Ru Yang
Address 65552 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 65552 0
Taiwan, Province Of China
Phone 65552 0
+886-2-2821-0271
Fax 65552 0
Email 65552 0
yryang@ym.edu.tw

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No Supporting Document Provided



Results publications and other study-related documents

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