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Trial registered on ANZCTR

Registration number

ACTRN12617000644369

Ethics application status

Approved

Date submitted

30/04/2017

Date registered

3/05/2017

Date last updated

11/06/2019

Date data sharing statement initially provided

11/06/2019

Type of registration

Prospectively registered

Titles & IDs

Public title

The effects of Functional Electrical Stimulation (FES) cycling, recreational cycling and goal-directed training on functional outcomes and participation in children with cerebral palsy - a randomized controlled trial

Scientific title

Secondary ID [1]

Nil

Universal Trial Number (UTN)

U1111-1196-0795

Trial acronym

Linked study record

Health condition

Health condition(s) or problem(s) studied:

Cerebral Palsy

Condition category

Condition code

Physical Medicine / Rehabilitation

Physiotherapy

Neurological

Other neurological disorders

Intervention/exposure

Study type

Interventional

Description of intervention(s) / exposure

The intervention will be an 8-week program of FES-powered cycling (FES-cycling), goal-directed and task-specific sit-to-stand transfer training and a home-based exercise program for children with CP who use an aid or wheelchair to mobilise.

The program will consist of 3 x 60 minute training sessions per week for 8 weeks (a total of 24 sessions, total dose of 24 hours). Two sessions per week will be conducted by a qualified physiotherapist at the Queensland Paediatric Rehabilitation Service (QPRS) at the LCCH, or at Griffith University, Gold Coast Campus. The third session each week will be completed as a home or community-based exercise program, supervised by the child’s parent/guardian. Each onsite visit will be broken into 30 minutes of FES-C (detailed below) followed by 30 minutes of goal-directed sit-to-stand (STS) transfer practice using a variety of progressive exercises and transfer tasks. The home exercise program will consist of up to 30 minutes of cycling using an adapted cycle and 30 minutes of goal-directed training. Participants will be able to use their own adapted tricycles/bikes if they have access to one or will be provided one on loan. The adapted cycles and various attachments will depend on the child's functional abilities and needs. Cycles may range from a simple recumbent bike with a backrest, to an upright tricycle with a high back rest, looped handle bars, a lap/trunk strap for support and foot straps to keep the child's feet on the pedals. The treating physiotherapist will attend a home visit prior to the study to assess cycling equipment and arrange necessary adaptations. To ensure adequate recovery time, training days will be separated by at least 24 hours.

FES-C training parameters will be as follows:

Frequency: 2 x sessions per week for 8 weeks;
Intensity: A percentage of maximum speed or power output will be used as training targets when cycling on the RT300 and intensity will be monitored by a pulse oximeter, with the aim to maintain >60% of the peak age-predicted heart rate (or >40% of HRR).
Duration: up to 30 mins;
Progression: Initially, some participants may need to start with shorter sessions while they become accustomed to FES, before progressing to sessions that are greater than 20 mins. Participants will begin cycling for as long as they can before fatigue (up to a maximum of 30 minutes), with the intention to progressively increase the resistance, cadence and cycling duration and reduce the level of motorized support.

FES will be delivered bilaterally via adhesive surface electrodes (as tolerated) to the quadriceps, hamstrings, gluteals, tibialis anterior and gastrocnemius muscles/muscle groups. The stimulation parameters for FES-C will be similar to those used in preliminary feasibility research on adolescents with CP and adjusted based on the participant’s tolerance (1-3). A global starting frequency of 40Hz - 50Hz will be used for all muscle groups. 40Hz is the default frequency on the RT300, however Harrington (2011) found that 50Hz was well tolerated by adolescents with CP (2,3). For smaller muscle groups such as the gluteals and gastrocnemius, a frequency closer to 40Hz may be more feasible. Pulse-width and amplitude will be adjusted based on participant’s tolerance, while ensuring that the overall intensity is sufficient to induce a motor response.

Goal-directed training parameters will be as follows:

Frequency: 2 sessions x per week for 8 weeks (as per FES-C training);
Intensity: 1-3 sets of 6-15 repetitions of each transfer-related task, or 50-85% of 1 rep max;
Duration: 30mins (following FES-C);
Type: Specific to individual participants and dependent on COPM goals. Examples include practicing transfers from different chair heights (incremented for difficulty by starting from a high chair height to low stool), transferring onto different surfaces (i.e. hard plinth vs a soft couch) or sit to stand practice, incremented for difficulty with weighted backpacks/belts. Activities will be designed to maintain participant motivation and provide enjoyment and sense of achievement.

In addition to the prescribed program, participants will be encouraged to increase the frequency of STS transfers at home and at school to consolidate training effects and to participate in recreational cycling beyond the prescribed training dose, if this is a form of physical activity that participants enjoy.

Training/treatment fidelity:
The treating therapist will be a physiotherapist registered under the Australian Health Practitioner Regulation Agency. The therapist will be trained in the administration of the Gross Motor Functional Measure (GMFM-66) by a senior therapist who is a qualified GMFM assessor. The study therapist will also have completed training in the use of the Canadian Occupational Performance Measure and the RT300 cycle ergometer in addition to attending multiple workshops and demonstrations run by an experienced physiotherapist. To maximize participant’s engagement in the home program, the treating physiotherapist will have appropriate knowledge of adapted cycling equipment/community funding for equipment.
Treatment fidelity will be monitored by: Video recording training sessions (with parent/caregiver consent); having one therapist conduct all sessions to ensure consistency; having participants complete training/usual care logs to track the home exercise training dose in addition to other training or therapeutic activities completed throughout the study. Due to the nature of the goal-based STS training, the content of the STS program may differ between participants, although efforts will be made to ensure a similar exercise dose.

1. Trevisi E, Gualdi S, De Conti C, Salghetti A, Martinuzzi A, Pedrocchi A, et al. Cycling induced by functional electrical stimulation in children affected by cerebral palsy: case report. European journal of physical and rehabilitation medicine 2012;48(1):135.
2. Harrington AT. The development of a functional electrical stimulation assisted cycling intervention to increase fitness and strength in children with cerebral palsy [Ph.D.]. Ann Arbor: University of Delaware; 2011.
3. Harrington AT, McRae CG, Lee SC. Evaluation of functional electrical stimulation to assist cycling in four adolescents with spastic cerebral palsy. International journal of pediatrics. 2012:1-11.
4. McRae C, Johnston T, Lauer R, Tokay A, Lee S, Hunt K. Cycling for children with neuromuscular impairments using electrical stimulation—Development of tricycle-based systems. Medical Engineering and Physics. 2009;31(6): 650-9.

Intervention code [1]

Rehabilitation

Comparator / control treatment

Participants in the immediate intervention group (Activate-CP) will be compared with a wait-list control group, who will receive the intervention after 10 weeks (After the immediate intervention group has completed baseline testing (week 1), 8 weeks of training (weeks 2-9), and post-training testing (week 10)). Both groups of participants will continue to receive ‘usual care’ throughout the study. Usual care refers to any therapeutic treatment or service that the child would normally receive outside of the intervention study. A usual-care log will be used to record in detail, the types and frequencies of interventions being received by all participants throughout the duration of the study.

Control group

Active

Outcomes

Primary outcome [1]

Gross Motor Function Measure (GMFM-66)

Timepoint [1]

Baseline: 1 week prior to starting the intervention (T1) Immediately post training (T2) Follow up - after an 8 week maintenance period (T3) Follow up - after an 8 week maintenance period for wait-list group only (T4)

Primary outcome [2]

Gross Motor Function Measure (GMFM-88)

Timepoint [2]

Primary outcome [3]

GMFM-88 goal sections

Timepoint [3]

Secondary outcome [1]

Canadian Occupational Performance Measure - COPM
(Self care and Leisure domains)

Timepoint [1]

Secondary outcome [2]

Five times Sit to Stand Test (FTSST)

Timepoint [2]

Secondary outcome [3]

Pediatric Evaluation of Disability Inventory (PEDI-CAT)

Timepoint [3]

Secondary outcome [4]

Habitual Physical Activity Level measured over 7 days using triaxial accelerometers (Actigraph GT3X+, Pensacola, FL, USA) and a physical activity log.

Timepoint [4]

Secondary outcome [5]

Peak power output recorded by the RT300 system during cycling performance test

Timepoint [5]

Secondary outcome [6]

Participation and Environment Measure - Children and Youth (PEM-CY)

Timepoint [6]

Secondary outcome [7]

Usual care log - record of the amount of therapy accessed outside the study intervention and to help quantify group differences in usual care.

Timepoint [7]

Completed by both groups throughout the entire study period, including during intervention, wait-list and maintenance periods.

Secondary outcome [8]

Participant's and/or parent's feedback and level of engagement, as reported through a telephone based, qualitative, semi-structured interview:

Timepoint [8]

For the immediate training group: Performed 8 weeks after ceasing the intervention (T3). For the waitlist group: Performed 8 weeks after ceasing the intervention (T4).

Secondary outcome [9]

Heart rate (HR) estimated by a finger or ear lobe pulse-oximeter (position on finger/ear lobe will depend on participant's preference)

Timepoint [9]

Weeks 1, 4 and 8 of the cycling program

Secondary outcome [10]

Cycling performance indicators from the RT300 system: Duration and distance cycled, average and maximum power output, average and peak resistance, Taken together, these results will demonstrate whether or not a training effect occurred during the cycling program.

Timepoint [10]

Recorded during the last FES-cycling session during the first, fourth and eighth weeks of training (for all participants who undertake FES-cycling training, including the waitlist group)

Secondary outcome [11]

Perceived enjoyment scale

Timepoint [11]

Each onsite cycling session - to monitor level of enjoyment

Eligibility

Key inclusion criteria

This study will include children and adolescents with a confirmed diagnosis of CP who at study entry are/have:
*Aged 6-18 years;
*Classified as functioning at GMFCS levels II, III or IV, as these groups are most likely to have functional goals that align with a STS transfer and cycling intervention;
*Goals to improve functional mobility, cycling ability or STS, stepping transfers developed in collaboration with the child, parent and therapist;
*Adequate range of motion (ROM) in their hips, knees and ankles to complete a full revolution of the RT300 (cycle ergometer) crank arm;
*Able to understand and follow instructions for GMFM-66 testing;
*Able to actively engage in up to 45 minutes of physiotherapy;
*Able to verbally or non-verbally communicate pain or discomfort;
*Able to attend training, testing and follow-up sessions at one of our training facilities.

Minimum age

6 Years

Maximum age

18 Years

Sex

Both males and females

Can healthy volunteers participate?

Key exclusion criteria

Exclusion criteria
*Unable to remain in a comfortable position to use the cycling equipment for a period of up to 30 minutes;
*Hypersensitivity to touch or unable to tolerate electrical stimulation;
*Hip displacement that causes severe pain and would prevent the child from participating in a cycling or sit-to-stand intervention;
*Lower limb joint contracture, severe spasticity or severely reduced ROM that could limit the child’s ability to complete a full cycling revolution;
*Surgery, trauma or fractures in the preceding 12 months who do not have medical clearance to participate in the 8 week Activate-CP intervention;
*Orthopaedic surgery or serial casting scheduled during the study period;
*Any contraindication for FES, including cardiac demand pacemakers, pregnancy or skin damage that may interfere with electrode placement;
*Any children with known cardiovascular or pulmonary diseases that have not received medical clearance to participate in the 8 week cycling intervention;
*Uncontrolled seizures or epilepsy.

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)

Children will be randomized centrally to receive either immediate training or be waitlisted to start training after 10 weeks of standard care, using an independent randomization service (not otherwise involved in the intervention study). Allocation will be confirmed to the local study therapist by the randomization service after the participant has been enrolled and baseline data has been collected.

Methods used to generate the sequence in which subjects will be randomised (sequence generation)

Participants will be stratified by GMFCS level (II, III, IV) and treatment site and randomized by the Griffith University Randomization Service using computer generated algorithms.

Masking / blinding

Blinded (masking used)

Who is / are masked / blinded?

The people assessing the outcomes

Intervention assignment

Other

Other design features

Wait-list controlled trial study design: Participants are randomly allocated to the immediate treatment group (commence training immediately) or a wait-listed to receive the intervention following primary data collection (After T2).

Phase

Not Applicable

Type of endpoint/s

Efficacy

Statistical methods / analysis

Sample size calculations:
The sample size was determined based on GMFM-66 change scores detected in previous studies in children with CP including (i) stationary cycling, (ii) a goal-directed, activity-focused training program and (iii) an intensive upper and lower limb training program which included transfer tasks. Taking into account the proposed treatment dose of 24 hours and severity level of participants (GMFCS levels III - IV), we propose a mean GMFM-66 change score of 3 logit points (100pt scale) as the minimum difference likely to indicate a meaningful clinical improvement. A sample size of 34 participants (17 in each group) are required per group to detect a mean change score of 3 points with 80% power (2-sided test at p<0.05). We require 40 children (20 participants in each group) to account for any attrition.

Data Analysis:
Standard principles for RCTs will be followed, using two-group comparisons on all subjects on an intention-to-treat basis. Imputation techniques will be employed to avoid any bias as a result of missing data during follow up. The primary comparison will be after 8 weeks (at T2) on the GMFM goal scores, GMFM-88 and 66 between groups using general linear models, with terms included for stratification and confounding variables (e.g. age and functional severity at baseline). Similar methods will be used to determine between group differences at 18 weeks, following an 8 week maintenance period (T3). For dichotomous outcomes, comparison will be by chi-square tests and multiple logistic regressions. Where continuous data exhibit skewness not overcome by transformation, non-parametric methods (Mann-Whitney U) will be used for simple comparisons.

Recruitment

Recruitment status

Active, not recruiting

Date of first participant enrolment

Anticipated

12/12/2017

Actual

30/01/2018

Date of last participant enrolment

Anticipated

1/03/2019

Actual

19/02/2019

Date of last data collection

Anticipated

30/09/2019

Actual

Sample size

Target

Accrual to date

Final

Recruitment in Australia

Recruitment state(s)

NSW,QLD

Recruitment hospital [1]

Lady Cilento Children's Hospital - South Brisbane

Recruitment postcode(s) [1]

4101 - South Brisbane

Funding & Sponsors

Funding source category [1]

University

Name [1]

Menzies Heath Institute Queensland, Griffith University

Address [1]

Menzies Health Institute Queensland
G40 Griffith Health Centre, Level 8.86
Gold Coast campus
Griffith University QLD 4222

Country [1]

Australia

Funding source category [2]

Hospital

Name [2]

Queensland Paediatric Rehabilitation Service, Lady Cilento Children's Hospital

Address [2]

501 Stanley St,
South Brisbane QLD 4101

Country [2]

Australia

Primary sponsor type

Individual

Name

Ellen Armstrong

Address

Level 6, Centre for Children's Health Research
62 Graham St,
South Brisbane QLD 4101

Country

Australia

Secondary sponsor category [1]

University

Name [1]

Griffith University

Address [1]

Menzies Health Institute Queensland
G40 Griffith Health Centre, Level 8.86
Gold Coast campus
Griffith University QLD 4222

Country [1]

Australia

Secondary sponsor category [2]

Hospital

Name [2]

Queensland Paediatric Rehabilitation Service, Lady Cilento Children's Hospital

Address [2]

501 Stanley St,
South Brisbane QLD 4101

Country [2]

Australia

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

The Children’s Health Queensland Hospital and Health Service Human Research Ethics Committee

Ethics committee address [1]

Human Research Ethics Committee
Level 7, Centre for Children’s Health Research
Lady Cilento Children’s Hospital Precinct
62 Graham Street
South Brisbane QLD 4101

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

24/04/2017

Approval date [1]

14/06/2017

Ethics approval number [1]

HREC/17/QRCH/88

Ethics committee name [2]

Human Research Ethics Committee, Griffith University

Ethics committee address [2]

Office for Research
Level 0, Bray Centre (N54)
Griffith University
170 Kessels Road
Nathan Qld 4111

Ethics committee country [2]

Australia

Date submitted for ethics approval [2]

19/05/2017

Approval date [2]

Ethics approval number [2]

Ethics committee name [3]

Children's Health Queensland Hospital and Health Service Research Governance

Ethics committee address [3]

CHQ Research Directorate
Level 7, Centre for Children's Health Research
Lady Cilento Children's Hospital
62 Graham Street, South Brisbane, QLD 410

Ethics committee country [3]

Australia

Date submitted for ethics approval [3]

27/06/2017

Approval date [3]

23/10/2017

Ethics approval number [3]

SSA/17/QRCH/145

Summary

Brief summary

The broad aim of this multi-site, randomised wait-list controlled trial is to determine the effectiveness of the 8-week program of FES-cycling and functional sit to stand (STS) training (2 x per week) and a home exercise program (1 x per week) of recreational cycling and STS training, to improve gross motor function, perceived performance and satisfaction of transfer-related occupational tasks (COPM) and cycling performance  in 40 children with moderate CP (GMFCS levels II-IV). Secondary aims are to determine the effects of the intervention on STS and activity capacity; participation at home, school and in the community; and habitual physical activity levels. A qualitative evaluation will independently examine engagement of children/adolescents and their families in the program.

This randomised wait-list controlled trial of 40 children with CP will compare an immediate intervention group, to a waitlist group, who will continue to receive usual care then receive the training program. Children/youth with CP who are/have: aged 8-18 years; functioning at GMFCS levels II, III or IV; goals to improve cycling ability or STS transfers; adequate range of motion (ROM) in the lower limbs to cycle will be recruited. Activate-CP will consist of 3 x 60 minute training sessions per week for 8 weeks (24 hours over 24 sessions). Two sessions will be FES-C and STS training. The third session will be completed at home including the STS training and recreational cycling. All FES-C training will be completed on an RT300-SLSA cycle (Restorative Therapies Inc.) designed for users to cycle while sitting in their own wheelchair. FES-electrodes will be applied to both quadriceps, hamstrings, gluteal, gastrocnemius and tibialis anterior muscles as tolerated, A global starting frequency of 40-50Hz will be applied and pulse-width and amplitude will be adjusted based on participant's tolerance. Participants will undertake STS transfers at home and at school to gain context-specific practice. Adapted and recumbent tricycles will be customized to meet individual needs for use at home and in the community.

The primary outcome is the Gross Motor Function Measure where an improvement of more than or equal to 3 points following the 8-week intervention is proposed (T2); along with greater perceived performance and satisfaction ratings (by more than or equal to 2 points) on Canadian Occupational Performance Measure (COPM) and improved cycling performance immediately following the intervention (T2). Secondary outcomes will test their STS transfer capacity (Five times STS test); activity capacity (PEDI-CAT), participation at home, school and in the community (PEM-CY), and 7 day habitual physical activity (HPA) levels.

Trial website

Trial related presentations / publications

Public notes

Participants will be recruited across South-East Queensland and Northern NSW, through a patient database at the Lady Cilento Children's Hospital in South Brisbane (post code: 4101)

Contacts

Principal investigator

Name

Miss Ellen Armstrong

Address

Level 6, Centre for Children's Health Research
62 Graham St,
South Brisbane QLD 4101

Country

Australia

Phone

+61 422877335

Fax

ellen.armstrong@griffithuni.edu.au

Contact person for public queries

Name

Ellen Armstrong

Address

Level 6, Centre for Children's Health Research
62 Graham St,
South Brisbane QLD, 4101

Country

Australia

Phone

+61 422877335

Fax

ellen.armstrong@griffithuni.edu.au

Contact person for scientific queries

Name

Ellen Armstrong

Address

Level 6, Centre for Children's Health Research
62 Graham St,
South Brisbane QLD, 4101

Country

Australia

Phone

+61 422877335

Fax

ellen.armstrong@griffithuni.edu.au

Data sharing statement

Will individual participant data (IPD) for this trial be available (including data dictionaries)?

No/undecided IPD sharing reason/comment

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	Effects of a training programme of functional electrical stimulation (FES) powered cycling, recreational cycling and goal-directed exercise training on children with cerebral palsy: A randomised controlled trial protocol.	2019	https://dx.doi.org/10.1136/bmjopen-2018-024881
Embase	Functional electrical stimulation cycling, goal-directed training, and adapted cycling for children with cerebral palsy: a randomized controlled trial.	2020	https://dx.doi.org/10.1111/dmcn.14648

N.B. These documents automatically identified may not have been verified by the study sponsor.

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