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Trial registered on ANZCTR


Registration number
ACTRN12616000670471
Ethics application status
Approved
Date submitted
6/04/2016
Date registered
23/05/2016
Date last updated
9/01/2019
Date data sharing statement initially provided
9/01/2019
Date results information initially provided
9/01/2019
Type of registration
Retrospectively registered

Titles & IDs
Public title
Effects of Functional Electrical Stimulation-cycling Plus Progressive Resistance Training on Muscle Strength After Incomplete Spinal Cord Injury: A Randomized Controlled Trial
Scientific title
Effects of Functional Electrical Stimulation-cycling Plus Progressive Resistance Training on Muscle Strength After Incomplete Spinal Cord Injury: A Randomized Controlled Trial
Secondary ID [1] 288244 0
none
Universal Trial Number (UTN)
U1111-1177-9811
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Spinal Cord Injury 297175 0
Condition category
Condition code
Neurological 297390 297390 0 0
Other neurological disorders
Injuries and Accidents 298691 298691 0 0
Other injuries and accidents
Physical Medicine / Rehabilitation 298872 298872 0 0
Physiotherapy

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The intervention group will receive 12 weeks Functional Electrical Stimulation (FES)-cycling (twice a week) plus progressive resistance training (once a week) which will be conducted by physiotherapist at research lab, University Malaya Medical Center, Kuala Lumpur. Each session for FES-cycling will be in a small group in 1 hour in duration which include electrodes to the quadriceps, hamstring, tibialis anterior and gastrocnemius while using Motomed cycling model VIVA 2 Parkinson which synchronize with Hasomed Rehamove 2 a FES machine during gait cycling. The parameters will be set with 300 microsecond pulse width, 30 Hz frequency, 35 rpm speed and 70-140 mA intensity. The participant will be register for attendance every training session.

The progressive resistance training involve electrodes on quadriceps, hamstring, tibialis anterior and gastrocnemius while using biodex isokinetic machine model no 850-230 which synchronize with Rehastim a portable FES. The resistance training on biodex machine will be based on manufacturer program which consist of 3-4 sets of resistance training with 10 repetitions at 50% RM and 5-10 second hold each repetition for 30 minutes. The number of sets will be progress at 70% RM at 6 weeks then to 100% RM at 10 weeks as determined by physiotherapist.
Intervention code [1] 294414 0
Rehabilitation
Comparator / control treatment
The control group will receive 12 weeks FES-cycling 3 times per week. Each session for FES-cycling will be 1 hour in duration which include electrodes to the quadriceps, hamstring, tibialis anterior and gastrocnemius while using Motomed cycling model VIVA 2 Parkinson which synchronize with Hasomed Rehamove 2 a FES machine during gait cycling. The parameters will be set with 300 microsecond pulse width, 30 Hz frequency, 35 rpm speed and 70-140 mA intensity.
Control group
Active

Outcomes
Primary outcome [1] 297907 0
voluntary quadriceps, hamstring, tibialis anterior and gastrocnemius strength (Nm) by using biodex isokinetic machine. This is a composite primary outcome.
Timepoint [1] 297907 0
before training, post 6 weeks training and post 12 weeks training
Primary outcome [2] 318604 0
Lower leg muscle volume. This outcome was assessed by using measurement tape. The leg was divided into six arbitrary cones. Each cone was measured by using the formula of:
Volume cone (L) = 1/12?? x H x (Cupper2 + (Cupper x Clower) + Clower2). Then all cones were summed together for ankle-to-thigh muscle volume.
Timepoint [2] 318604 0
before, post 6 weeks and post 12 weeks training
Secondary outcome [1] 322590 0
heart rate by using portable pulse oximetry
Timepoint [1] 322590 0
before training, post 6 weeks training and post 12 weeks training
Secondary outcome [2] 323393 0
Oxygen saturation uptake by using portable SPO2 machine
Timepoint [2] 323393 0
before training, post 6 weeks training and post 12 weeks training

Eligibility
Key inclusion criteria
over 2 years incomplete SCI. ASIA C and D only
Level of injury C4-T12
Have at least 90 degree knee range of motion
Able to response to FES
Able to follow command
Minimum age
18 Years
Maximum age
50 Years
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Had recent history of trauma to the lower limb
Severe of infected skin pressure sore on weight-bearing skin areas
Uncontrolled spasticity or pain
History of cardiovascular problem
History of cardiorespiratory problem
Metal implants in femur or tibia bone

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)
The rehabilitation medicine physician will screen all participants for inclusion and exclusion criteria. Then they will be randomly picked by uninvolved person from the list name based on the sample size needed.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
a simple random sampling will be used to allocate participants into intervention group and control group using simple coin toss by a person uninvolved with the study.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint(s)
Efficacy
Statistical methods / analysis
The G-Power 3 software will be used to determine the sample size for this study. The effect size is 0.25. Based on the results an estimated sample of 28 participants could provide 80% power with risk of type 1 error of 0.05.

The descriptive analysis (mean and standard deviation) of demographic data and maximum voluntary contraction will be recorded. Meanwhile means differences between the baseline within group factor of pre-exercise, 6 weeks and 12 weeks will be analyzed using ANOVA repeated measures. Post-hoc Bonferroni comparison will be used to analyze the baseline that is most significant.

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] 7784 0
Malaysia
State/province [1] 7784 0
kuala lumpur

Funding & Sponsors
Funding source category [1] 293294 0
University
Name [1] 293294 0
High Impact Research Grant, University Malaya, Kuala Lumpur
Address [1] 293294 0
Department Biomedical Engineering,
Faculty Of Engineering,
University Malaya,
Jalan University,
50603, Kuala Lumpur

Country [1] 293294 0
Malaysia
Primary sponsor type
University
Name
High Impact Research Grant, University Malaya, Kuala Lumpur
Address
Department Biomedical Engineering,
Faculty Of Engineering,
University Malaya,
Jalan University
50603, Kuala Lumpur,
Country
Malaysia
Secondary sponsor category [1] 292095 0
None
Name [1] 292095 0
Address [1] 292095 0
Country [1] 292095 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 294768 0
University Malaya Medical Center Medical ethics committee
Ethics committee address [1] 294768 0
university Malaya Medical Centre,
jalan university,
59100, kuala lumpur
Ethics committee country [1] 294768 0
Malaysia
Date submitted for ethics approval [1] 294768 0
Approval date [1] 294768 0
28/08/2014
Ethics approval number [1] 294768 0
1003.14(1)

Summary
Brief summary
A spinal cord injury (SCI) is a chronic health condition in which the individual loses certain functions, no longer being able to exercise them in the same way as before the injury (Vall, Mauricio, Costa, Pereira, & Friesen, 2011). SCI can induce prolonged inactivity and subsequent secondary complications such as muscle atrophy, pressure ulcers, and demineralization of the lower limb bones (Yoshida et al., 2013). Patients who survive with SCI often left with considerable residual disability that require longterm care for hospitalization, rehablitation and home care services (Wyndaele & Wyndaele, 2006).
In United states, the incidence of SCI is approximately 40 cases per million population per year. The average age at time of injury is 31.7 years, with teenagers and young adults having the greatest risk (Livecchi, 2011). However, in Malaysia among all survivors of SCI about 50% of the patients experienced severe SCI (ASIA A or B), mainly involving patients in the age group 16 to 45 and experiencing traumatic SCI (Ibrahim et al., 2013).
Musculoskeletal atrophy is a serious complication of SCI which contributes to the development of secondary impairements in spinal cord injured individuals. Although better medical care of persons with SCI has helped to progressively improve their health and life expectancy over the last six decades, gains in mobility and self-care skills have remained relatively stagnant because further improvements in these areas are dependent on advancements in basic science that may lead to reversal of the neurological loss (Ragnarsson, 2008). Thus, it is well accepted among healthcare professionals and now diplomats worldwide that regular physical activity is a cornerstone of physical and psychologic well-being.
Since the 1960s, FES-induced muscle contractions have been widely used as a rehabilitation therapy or an exercise regimen for the paralyzed lower limbs of people with SCI. With FES, paralyzed legs can be artificially evoked to produce otherwise unattainable dynamic movements, such as cycling, rowing, knee extension, standing, and stepping (Davis, Hamzaid, & Fornusek, 2008). On the basis of this observation, FES cycle ergometers have been designed and extensively tested and prescribed for persons with SCI based on established clinical benefits. It can be performed either as static muscle contractions and dynamic knee extension (Hettinga & Andrews, 2008).
FES-LCE did improve muscular strength and endurance, increase exercise Performance, and improve cardiovarcular response (Thrasher, Ward, & Fisher, 2013 ; Davis et al, 2008). However, the persistance of the result from the exercise training still unknown. Therefore, in this study the objective is to investigate the effects of FES-cycling ergometer plus progression resistance exercise on muscle strength and cardiovascular response among incomplete SCI patient.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 62498 0
Mrs Nurhaida Rosley
Address 62498 0
Department of Physiotherapy
Faculty of Health Sciences
Universiti Teknologi MARA
42300, Puncak Alam
Selangor
Country 62498 0
Malaysia
Phone 62498 0
+60136220157
Fax 62498 0
Email 62498 0
nurhaida.rosley@gmail.com
Contact person for public queries
Name 62499 0
Dr Haidzir Manaf
Address 62499 0
Department of Physiotherapy
Faculty of Health Sciences
Universiti Teknologi MARA
42300, Puncak Alam
Selangor
Country 62499 0
Malaysia
Phone 62499 0
+60126615246
Fax 62499 0
Email 62499 0
haidzirmanaf@yahoo.com
Contact person for scientific queries
Name 62500 0
A/Prof Nazirah Hasnan
Address 62500 0
Department of Rehabilitation Medicine,
Faculty of Medicine,
University Malaya,
50603, Kuala Lumpur
Country 62500 0
Malaysia
Phone 62500 0
+6012-3286844
Fax 62500 0
Email 62500 0
nazirah@ummc.edu.my

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
this data will be kept by the researcher.
What supporting documents are/will be available?
Ethical approval
How or where can supporting documents be obtained?
Type [1] 670 0
Ethical approval
Citation [1] 670 0
Link [1] 670 0
Email [1] 670 0
Other [1] 670 0
Summary results
Have study results been published in a peer-reviewed journal?
No
Other publications
Have study results been made publicly available in another format?
No
Results – basic reporting
Results – plain English summary