Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12616000744459
Ethics application status
Approved
Date submitted
28/05/2016
Date registered
6/06/2016
Date last updated
4/06/2019
Date data sharing statement initially provided
4/06/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
Electrical stimulation cycling exercise in persons with cerebral palsy
Scientific title
Feasibility of functional electrical stimulation cycling exercise in persons with moderate cerebral palsy: a pilot study
Secondary ID [1] 288756 0
Nil known
Universal Trial Number (UTN)
U1111-1180-7937
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
cerebral palsy
 298004 0
Condition category
Condition code
Neurological 298160 298160 0 0
Other neurological disorders
Physical Medicine / Rehabilitation 299027 299027 0 0
Other physical medicine / rehabilitation

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Pilot Study of Functional Electrical Stimulation (FES) Cycling Exercise in Cerebral Palsy

It is necessary for persons with cerebral palsy (CP) to exercise in order to prevent secondary comorbidities later in life such as declining physical performance, health and premature sarcopenia. However, persons with CP with more severe mobility limitation often have reduced options for exercise and often the exercise intensity that can be achieved is low. Functional electrical stimulation (FES) leg cycling may be useful to enhance exercise options and bestow benefit in persons with CP. FES may be able to assist voluntary contractions and achieve a training effect on lower limb muscle mass leading to changes in function and quality of life. However, FES cycling has many disadvantages, including the cost of equipment, the time invested in setting up the equipment each session, and that the stimulation sensation is unpleasant. Prior to this application, we have demonstrated the feasibility of our method of FES cycling for persons with advanced multiple sclerosis (MS) (Fornusek 2014). Clinical findings in CP can be similar to advanced MS with paresis, hypertonia and variable but often preserved sensation. This study examines the feasibility of FES cycling in persons with moderate CP (GMFCS-III).

Participants will perform FES cycling training (2 x per week for 45min per session) for 8 weeks at 10 RPM on a custom isokinetic functional electrical stimulation cycle ergometer (University of Sydney). The sessions will be administered one-on-one by physiotherapy and exercise science students from the University of Sydney with overseeing supervision from a rehabilitation engineer with 20 years experience in FES cycle design and training experience. The FES cycling training program has been adapted to suit persons with CP and enhance muscle hypertrophy. The duration and intensity of each exercise session will be tailored to the initial strength and fitness levels of each individual and exercise duration will be increased gradually over the first 3 weeks up to 45 min. The quadriceps, gluteal muscles, hamstrings, and tibialis anterior muscles of each leg will be stimulated via self-adhesive gel electrodes. The stimulation parameters will be 300 microsecond pulse width and 35 Hz pulse frequency. The pulse amplitude (mA) will be personalized to the individual tolerance of each individual and slowly increased from the beginning of each session as the participant becomes accustomed to the uncomfortable sensation. Exercise intensity will be enhanced by the participant contributing voluntary contractions to the cycling action where possible. A computer display will provide participants with visual feedback of their cycling performance. The FES cycling intervention will be performed at the FitAbility Clinic (C Block) at the School of Exercise & Sports Science (Faculty of Health Sciences, The University of Sydney).

This pilot study is to test the feasibility of using FES cycling in adolescents with cerebral palsy and collect data for a larger future study. Feasibility will assessed from the appropriateness, acceptability, number of adverse events, and adherence rate of the intervention. Adherence will be evaluated by average percentage of sessions and amount of training time completed in the 8 week training. Reasons for absences from training will be recorded. Appropriateness and acceptability will be assessed by a custom survey. Effectiveness will be assessed via secondary health and functional measures that might be enhanced due to the exercise intervention.
Intervention code [1] 294193 0
Rehabilitation
Intervention code [2] 294899 0
Treatment: Devices
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 297702 0
Adherence will be evaluated by average percentage of sessions and amount of training time completed in the 8 week training program. Reasons for absences from training will be recorded.
Timepoint [1] 297702 0
Immediately post the exercise intervention (8 weeks)
Secondary outcome [1] 321914 0
Lower limb muscle mass - estimated using ultrasound and circumference (cm) of calf and thigh using a tape measure.
Timepoint [1] 321914 0
Before (Week 1 pre-test) and immediately after training intervention (Week 10 post-test)
Secondary outcome [2] 321916 0
Leg extension and leg flexion strength (Biodex System 2 Dynamometer)
Timepoint [2] 321916 0
Before (Week 1 pre-test) and immediately after training intervention (Week 10 post-test)
Secondary outcome [3] 321918 0
Gait (1 min fast walk test)
Timepoint [3] 321918 0
Before (Week 1 pre-test) and immediately after training intervention (Week 10 post-test)
Secondary outcome [4] 321919 0
Spasticity/tone (ASAS - Australian Spasticity Assessment Scale)
Timepoint [4] 321919 0
Before (Week 1 pre-test) and immediately after training intervention (Week 10 post-test)
Secondary outcome [5] 324264 0
After the training period participants will complete an ad hoc survey which has been specially designed for the study. The survey will be used to determine what the participant’s perceived as the benefits and drawbacks of intervention, how tolerable the interventions was, and rating changes in their leg strength, spasticity, and fitness over the last 8 weeks.
Timepoint [5] 324264 0
After training intervention (Week 10 - post-test) and 8 weeks after the intervention and testing have finished (week 18 - follow up)
Secondary outcome [6] 324265 0
30 second Sit to Stand test
Timepoint [6] 324265 0
Before (Week 1 pre-test) and immediately after training intervention (Week 10 post-test)
Secondary outcome [7] 324266 0
Aerobic Fitness (10m Shuttle run test for GMFCS-III)
Timepoint [7] 324266 0
Before (Week 1 pre-test) and immediately after training intervention (Week 10 post-test)
Secondary outcome [8] 324267 0
Incremental Leg Cycling test
Timepoint [8] 324267 0
Before (Week 1 pre-test) and immediately after training intervention (Week 10 post-test)
Secondary outcome [9] 324268 0
Lower limb (hip, knee, angle) passive range of motion as measured by goniometry.
Timepoint [9] 324268 0
Before (Week 1 pre-test) and immediately after training intervention (Week 10 post-test)
Secondary outcome [10] 324269 0
Participant Quality of Life (CPQol-Teen)
Timepoint [10] 324269 0
Before (Week 1 pre-test) and immediately after training intervention (Week 10 post-test), 8 weeks after intervention (Week 18- follow-up)
Secondary outcome [11] 324270 0
Body mass: A calibrated weighing scale will be used to measure body mass.
Timepoint [11] 324270 0
Before (Week 1 pre-test) and immediately after training intervention (Week 10 post-test)
Secondary outcome [12] 324357 0
Waist circumference will be recorded at the mid-point between the lowest rib and the top of the hip bone
Timepoint [12] 324357 0
Before (Week 1 pre-test) and immediately after training intervention (Week 10 post-test)
Secondary outcome [13] 324506 0
Lower limb (hip, knee, angle) active range of motion as measured by goniometry.
Timepoint [13] 324506 0
Before (Week 1 pre-test) and immediately after training intervention (Week 10 post-test)

Eligibility
Key inclusion criteria
The inclusion criteria for participants are:
1) 13-18 years old
2) The diagnosis of Cerebral Palsy
3) GMFCS Level III (uses an assistive mobility device or a wheelchair for long distances)
4) Sufficient covering of the femoral head in the acetabulum (MIGR% < 40%) and no significant scoliosis (primary curve >40 degrees).
5) Absence of severe tactile hypersensitivity in the lower extremities
6) Visuoperceptual skills sufficient to follow multiple step commands and to attend to tasks associated with data collection
7) The ability to maintain an upright position with minimal support and to sit in a wheelchair for approximately one hour.
8) Have adequate passive range of motion of the hips, knees and ankle to complete a full revolution of the cycle ergometer.
9) Ability to communicate pain or discomfort directly with the researcher or indirectly via a carer to participate in cycling trials (Communication Function Classification System less than or equal to 3)
10) The willingness to participate in two training sessions per week for 8 weeks lasting approximately 1 hour each session (approximately 15 min of set up and up to 45 minutes of training) and to complete 2-3 days of testing during each assessment period (baseline, post testing).
11) The ability to gain consent from participant and parent/guardian
Minimum age
13 Years
Maximum age
18 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Exclusion criteria are:
1) Lower extremity joint pain during cycling
2) Spinal fusion that extends to the pelvis
3) Hip, knee, or ankle joint instability or dislocation
4) History of lower limb stress fractures in the past year
5) Pulmonary disease limiting exercise tolerance
6) Symptomatic or known cardiac disease
7) Unhealed wounds or pressure sores
8) Muscles that are non-responsive to electrical stimulation
9) History of surgery or traumatic fracture to the lower extremities within the past year
10) Botox injections to the lower extremity muscles within the past 6 months.
11) Severe spasticity in legs (score of 4 on the Modified Ashworth scale)
12) Severely limited range of joint motion/irreversible muscle contractures that prevent the subject from being able to be safely positioned on the cycle.
13) Presence of an uncontrolled seizure disorder
14) Pregnancy

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Not applicable
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Not applicable
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
This study will aim to recruit 12 participants.

There is little prior evidence on electrical stimulation exercise for persons with CP and a sample size of 12 participants is greater than in the current literature on FES cycling studies for CP. Previous studies on persons with multiple sclerosis (Fornusek 2013) suggest that 8 weeks of training (2-3 times per week) should be sufficient to induce significant muscle mass changes. As this is a small feasibility study, no formal sample size was calculated. However, twelve participants should detect a meaningful increase in muscle mass (i.e. 10%; 80% statistical power, SD = 7%, a=.05, 1 tail, 15% non-compliance) if the muscles of those with CP respond similar to those with multiple sclerosis or spinal injury. In persons with spinal cord injury a 10% increase has been shown to improve glucose tolerance and inflammatory markers (Skold 2002, Griffin 2009).

Adherence to exercise (primary measure) is defined as performing 75% or more of the intervention as it was prescribed by frequency of days/week exercise and total duration of exercise in minutes/week.

The secondary measures that might be enhanced by FES leg cycling exercise will also be assessed before and after the intervention. Analysis will be by intention-to-treat. Treatment effect between groups will be determined using a linear regression approach to analysis of covariance (ANCOVA) to adjust for baseline differences of respective covariate. Precision of treatment effect will be based on the 95% CI and p<0.05.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
1/07/2017
Actual
26/02/2018
Date of last participant enrolment
Anticipated
1/12/2020
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
12
Accrual to date
1
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 5813 0
The Children's Hospital at Westmead - Westmead

Funding & Sponsors
Funding source category [1] 293627 0
University
Name [1] 293627 0
The Univeristy of Sydney
Country [1] 293627 0
Australia
Primary sponsor type
Individual
Name
Dr Che Fornusek
Address
C103
Faculty of Health Sciences
The University of Sydney
75 East St
Lidcombe
NSW 2141
Country
Australia
Secondary sponsor category [1] 292459 0
None
Name [1] 292459 0
Address [1] 292459 0
Country [1] 292459 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 295065 0
Human Research Ethics Committee
Ethics committee address [1] 295065 0
THE UNIVERSITY OF SYDNEY
Level 2 Margaret Telfer Building (K07)
The University of Sydney
NSW 2006
Ethics committee country [1] 295065 0
Australia
Date submitted for ethics approval [1] 295065 0
21/01/2016
Approval date [1] 295065 0
24/03/2016
Ethics approval number [1] 295065 0
2016/106

Summary
Brief summary
Aim: The primary aim of this project is to evaluate the feasibility of functional electrical stimulation cycling exercise for persons moderately affected cerebral palsy. Electrical stimulation uses brief electrical pulses applied via gel-electrodes to the muscles to produce muscle contractions in weak or paralyzed muscles. Functional Electrical Stimulation cycling devices rhythmically apply electrical stimulation to the leg muscles to induce muscle contractions that can cause paralyzed legs to pedal a stationary exercycle and exercise the legs. Electrical stimulation exercises has many disadvantages, including the cost of equipment, the time invested in setting up the equipment each session and the low intensity of exercise it provides. However, persons with CP who have more severe mobility limitations often have less options for exercise, and even though it has many drawbacks electrical stimulation may be a good exercise mode for this population.

Intervention: In this project twelve adolescents with moderate CP (i.e. gross motor function classification scale III) will perform 8 weeks of functional electrical cycling training at the Faculty of Health Sciences, University of Sydney. The method of functional electrical stimulation cycling which will be employed is one which we have shown to produce better enhancements in muscle mass than prior methods of electrical stimulation cycling. Participants will perform cycling two times per week and each session will involve 45min of exercise. Eight muscle groups will be electrically stimulated via self-adhesive gel electrodes. The quadriceps, gluteal muscles, hamstrings, and calf muscles of each leg will be electrically stimulated. We will measure the outcome variables before and after the 8 week intervention.

Hypothesis: The primary hypothesis tested is that our method of electrical stimulation cycling is a feasible form of exercise for persons with moderate CP. We believe that appropriately designed ES-cycling exercise can enhance the exercise options that persons with moderate cerebral palsy can currently perform. We will measure feasibility through adherence to the program and test outcome measures related to health and function. Secondary hypotheses include that regular exercise with an appropriate ES cycling system results in leg muscle hypertrophy (assessed via ultrasound and leg circumference measures) in people with moderate CP and consequently produces improvements in lower limb function, and quality of life. Evaluation of our secondary hypotheses also include measures of perceived quality of life, cycling ability, leg extension strength, leg flexion strength, gait and leg function, and spasticity/tonus.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 64362 0
Dr Che Fornusek
Address 64362 0
C103, Faculty of Health Science, University of Sydney 75 East Street Lidcombe, NSW 2141
Country 64362 0
Australia
Phone 64362 0
+61403997552
Fax 64362 0
+61293519204
Email 64362 0
[email protected]
Contact person for public queries
Name 64363 0
Dr Che Fornusek
Address 64363 0
C103, Faculty of Health Science, University of Sydney 75 East Street Lidcombe, NSW 2141
Country 64363 0
Australia
Phone 64363 0
+61293519200
Fax 64363 0
+61293519204
Email 64363 0
[email protected]
Contact person for scientific queries
Name 64364 0
Dr Che Fornusek
Address 64364 0
C103, Faculty of Health Science, University of Sydney 75 East Street Lidcombe, NSW 2141
Country 64364 0
Australia
Phone 64364 0
+61403997552
Fax 64364 0
+61293519204
Email 64364 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
No ethics clearance was requested for data sharing.


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
2210Ethical approval    370326-(Uploaded-29-05-2019-12-58-11)-Study-related document.pdf



Results publications and other study-related documents

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No documents have been uploaded by study researchers.

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No additional documents have been identified.