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Trial registered on ANZCTR


Registration number
ACTRN12621001133820
Ethics application status
Approved
Date submitted
1/07/2021
Date registered
23/08/2021
Date last updated
23/02/2023
Date data sharing statement initially provided
23/08/2021
Type of registration
Prospectively registered

Titles & IDs
Public title
ACTIVE STRIDES-CP: Effect of Intensive rehabilitation for children with moderate to severe cerebral palsy on gross motor skills and physical activity participation
Scientific title
ACTIVE STRIDES-CP: Randomised trial Combined Intensive Gait and Cycling Training for gross motor skills and physical activity participation in children with moderate to severe bilateral cerebral palsy
Secondary ID [1] 304482 0
None
Universal Trial Number (UTN)
U1111-1280-8194
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Cerebral Palsy 322319 0
Condition category
Condition code
Neurological 319989 319989 0 0
Other neurological disorders
Musculoskeletal 319990 319990 0 0
Other muscular and skeletal disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
ACTIVE STRIDES-CP is an intensive program of Functional Electrical Stimulation Cycling, Partial Body Weight Support Treadmill Training (PBWTT) and goal directed training.

Dose: We will deliver a total dose of 32 hours of direct therapy which will be delivered over 8 weeks. This comprises 2 x weekly clinic visits of 1.5 hours duration, 4 home visits of 1 hour duration (alternate weeks) and 4 telehealth sessions of 1 hour duration (alternative weeks to home visits.)
Mode: Individual intervention with a ratio of 2:1 therapist + therapy assistant for child on-site training. Face-to face clinic sessions and home visits. Telehealth for 4 sessions.
Intervention Providers: Physiotherapists or exercise physiologists delivering ACTIVE STRIDES CP will complete standardised training provided by the CI team. The trained providers will provide direction to allied health assistants assisting with the on-site (clinical setting) sessions.
Content and tailoring: ACTIVE STRIDES-CP is a motor training approach comprising a rehabilitation package of up to 30 mins/session each of (i) assisted FES cycling, (ii) partial body weight support treadmill/ over ground walking, and (iii) planning/revision of the goal directed home exercise program (based on functional goals targeted at activity performance or participation) and 4 x fortnightly 1hr home visits to practice recreational cycling (individualized adapted bike), over ground walking (using gait trainers) and goals in context, and on alternating weeks, 4 x fortnightly 1hr telehealth sessions. FES cycling consists of 3 x 10 minute cycling phases ( 2 x self-selected cadence, 1 sprints). The aim will be to progress speed, resistance and power output each session. PBWSTT comprises 3 x 10 minute sets using a treadmill and overhead hoist. Over time, speed will be increased and support will be decreased. Two to three functional mobility or cycling related goals will be set and developed as a home program.
Target intensity: During FES cycling, training intensity is aimed to be >60% of age-predicted heart rate maximum for two phases and >80% during sprints. During PBWSTT, training intensity is aimed to be 70% heart rate maximum.
Fidelity: All providers will complete standardised training to deliver ACTIVE STRIDES-CP and meet specified competencies to deliver each aspect of the intervention. Following each intervention session, therapists will complete a session checklist and reflection to ensure that all elements have been recorded, and that ongoing incrementation of the program is occurring. Intervention sessions will be video recorded and a random sample reviewed against a bespoke fidelity checklist (first 2 sessions for each interventionist and then 10% of sessions thereafter).
Intervention code [1] 320839 0
Rehabilitation
Intervention code [2] 320840 0
Treatment: Other
Comparator / control treatment
Usual care over the 6 month wait-list period will vary across Australia and could range from weekly clinic-based therapy sessions to school-based consultative services provided on a monthly, quarterly or yearly basis. All families in both groups will complete a usual care diary for the duration of study involvement to record the frequency and duration of therapy, exercise activities and any concurrent medical interventions such as intramuscular Botulinum Toxin A injections and/or serial casting. All children in CAU group will be offered ACTIVE STRIDES-CP after the 6-month retention (T3).
Control group
Active

Outcomes
Primary outcome [1] 327865 0
Gross Motor Function (Gross Motor Function Measure (GMFM-66)
GMFM-66 for an overall measure of gross motor function capacity as the primary outcome.
Timepoint [1] 327865 0
(T1: Baseline)
(T2: 9 weeks); Primary timepoint
(T3: 26 weeks) for retention at 6 months post baseline
Secondary outcome [1] 396808 0
Daily time spent sedentary -
Habitual physical activity (HPA) as assessed using triaxial accelerometers, will be worn during waking hours for 7 days to determine time spent sedentary.
Timepoint [1] 396808 0
(T2: 9 weeks); and for retention at 6 months post baseline (T3: 26 weeks)
Secondary outcome [2] 396809 0
Walking endurance - using Six Minute Walk Test (6MWT)
Timepoint [2] 396809 0
(T2: 9 weeks); and for retention at 6 months post baseline (T3: 26 weeks)
Secondary outcome [3] 396810 0
Maximal walking speed (10m fast walk test (10mFWT))
Timepoint [3] 396810 0
(T2: 9 weeks); and for retention at 6 months post baseline (T3: 26 weeks)
Secondary outcome [4] 396811 0
Pediatric Evaluation of Disability Inventory Computer Adapted Test (PEDI-CAT): The parent-reported PEDI-CAT measures performance of daily activities and mobility using normative standard scores and scaled scores with good validity, reliability, standardisation on TDC. The speedy version will be administered on-line.
Timepoint [4] 396811 0
(T2: 9 weeks); and for retention at 6 months post baseline (T3: 26 weeks)
Secondary outcome [5] 396812 0
Physiological Cost Index (PCI) will be measured using heart rate (HR) throughout each intervention session on a Polar Heart Rate Monitor.
Timepoint [5] 396812 0
(T2: 9 weeks); and for retention at 6 months post baseline (T3: 26 weeks)
Secondary outcome [6] 396813 0
Perceived performance of individualised goals (Canadian Occupational Performance Measure COPM)
Children will set a maximum of two to three goals related to mobility or adapted cycling.
Timepoint [6] 396813 0
(T2: 9 weeks); and for retention at 6 months post baseline (T3: 26 weeks)
Secondary outcome [7] 396815 0
The Cerebral Palsy Quality of Life-child (CPQOL-child) assesses wellbeing using parent-report (4-12 years) and child self-report from 9 years.
Timepoint [7] 396815 0
(T2: 9 weeks); and for retention at 6 months post baseline (T3: 26 weeks)
Secondary outcome [8] 396816 0
The Child Health Utility-9D (CHU-9D) is a generic instrument for children aged 7-11 years giving a single preference-based utility index for health states, making the data amenable for
economic evaluations for interventions
Timepoint [8] 396816 0
(T2: 9 weeks); and for retention at 6 months post baseline (T3: 26 weeks)
Secondary outcome [9] 398560 0
Satisfaction with individualised goals (Canadian Occupational Performance Measure - COPM)
Timepoint [9] 398560 0
(T2: 9 weeks); and for retention at 6 months post baseline (T3: 26 weeks)
Secondary outcome [10] 398847 0
Standing
GMFM-88 domain D
Timepoint [10] 398847 0
(T2: 9 weeks); and for retention at 6 months post baseline (T3: 26 weeks)
Secondary outcome [11] 398848 0
Walking
GMFM-88 domain E
Timepoint [11] 398848 0
(T2: 9 weeks); and for retention at 6 months post baseline (T3: 26 weeks)
Secondary outcome [12] 398852 0
Daily time spent in light to moderate physical activity:
Habitual physical activity (HPA) as assessed using triaxial accelerometers, will be worn during waking hours for 7 days to determine time spent in light to moderate physical activity.
Timepoint [12] 398852 0
(T2: 9 weeks); and for retention at 6 months post baseline (T3: 26 weeks)
Secondary outcome [13] 398853 0
Daily time spent in moderate to vigorous physical activity:
Habitual physical activity (HPA) as assessed using triaxial accelerometers, will be worn during waking hours for 7 days to determine time spent in vigorous physical activity.
Timepoint [13] 398853 0
(T2: 9 weeks); and for retention at 6 months post baseline (T3: 26 weeks)
Secondary outcome [14] 398854 0
Performance of individualised goals (Canadian Occupational Performance Measure - COPM)
Timepoint [14] 398854 0
(T2: 9 weeks); and for retention at 6 months post baseline (T3: 26 weeks)

Eligibility
Key inclusion criteria
Children diagnosed with bilateral CP (diplegia/quadriplegia), GMFCS III (walks with
limitations) to IV (limited self-mobility); (b) aged 5-15 yrs; (c) have goals to improve mobility,
cycling, sit-to-stand or stepping transfers; (d) able to attend training, testing and follow-up sessions; (e) able to follow instructions to perform GMFM and intervention; (f) not expected to undergo lower limb orthopaedic or neurosurgery (e.g. Selective Dorsal Rhizotomy) during the study period. If they have received lower limb orthopaedic surgery in the previous 12 months then study entry will be delayed; (g) medically fit to undertake moderate intensity exercise; (h) adequate range of motion (ROM) in their hips, knees and ankles to complete a full revolution of the RT300 cycle (Restorative Therapies Inc., Baltimore) crank arm; (i) able to verbally or non-verbally communicate pain or discomfort.
Minimum age
5 Years
Maximum age
15 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
(a) lower limb joint contracture, severe spasticity or severely
reduced ROM that limits ability to complete a full cycling revolution; (b) uncontrolled epilepsy (not controlled by medication) as this would be a confounder; (c) surgery, trauma or fractures in the preceding 12 months without medical clearance to participate; (d) cardiovascular or pulmonary diseases without medical clearance to participate in the 8-week intervention.

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)
An electronic system will determine allocation, completed by non-study personnel. Group allocation will be concealed to the treating therapist, research team, and the family until after all baseline measures are completed.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a randomisation table created by computer software (i.e. computerised sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Analyses will follow standard principles for RCTs using two-group comparisons on all participants on an intention-to-treat basis. Primary comparison at 9 weeks (T2 post) on GMFM performance and satisfaction will be between treatment groups using linear regression with treatment group (ACTIVE STRIDES-CP/waitlist control) included as the main effect and stratification factors as co-variables. Effect estimates will be presented as mean difference and 95% confidence interval. Secondary analyses will use similar methods to compare outcomes between groups at 9weeks for HPA level and sedentary behaviours, and self and parent-proxy reported quality of life (CPQOL-Child). In cases where interval data cannot be transformed appropriately for regression analyses, non-parametric methods (Mann-Whitney U) will be used for between-treatment comparisons. Recruitment bias will be assessed by comparing sociodemographic and clinical variables for consenters with non-consenters using t-tests (or Mann-Whitney U tests) for continuous variables and chi-squared tests for categorical variables. Possible differential attrition will be assessed by comparing baseline characteristics of drop-outs and continuing participants using t-tests (or Mann-Whitney U tests if appropriate) for continuous variables and chi-squared tests for categorical variables. Sensitivity analyses of all outcomes will be conducted using multiple imputation techniques, to investigate the effect of non-ignorable missing data during follow up.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
1/09/2022
Actual
1/08/2022
Date of last participant enrolment
Anticipated
1/04/2025
Actual
Date of last data collection
Anticipated
1/11/2025
Actual
Sample size
Target
150
Accrual to date
4
Final
Recruitment in Australia
Recruitment state(s)
NSW,QLD,WA,VIC
Recruitment hospital [1] 19739 0
Queensland Children's Hospital - South Brisbane
Recruitment hospital [2] 19740 0
The Royal Childrens Hospital - Parkville
Recruitment hospital [3] 19741 0
Cerebral Palsy Alliance - Allambie Heights
Recruitment postcode(s) [1] 34377 0
6000 - Perth
Recruitment postcode(s) [2] 34378 0
4101 - South Brisbane
Recruitment postcode(s) [3] 34379 0
2075 - St Ives
Recruitment postcode(s) [4] 34380 0
3052 - Parkville
Recruitment postcode(s) [5] 34381 0
2100 - Allambie Heights

Funding & Sponsors
Funding source category [1] 308843 0
Government body
Name [1] 308843 0
National Health and Medical Research Council
Country [1] 308843 0
Australia
Primary sponsor type
University
Name
The University of Queensland
Address
The University of Queensland St Lucia QLD 4072
Country
Australia
Secondary sponsor category [1] 309759 0
None
Name [1] 309759 0
Address [1] 309759 0
Country [1] 309759 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 308750 0
Children's Health Queensland Human Research Ethics Committee
Ethics committee address [1] 308750 0
Ethics committee country [1] 308750 0
Australia
Date submitted for ethics approval [1] 308750 0
19/07/2021
Approval date [1] 308750 0
15/09/2021
Ethics approval number [1] 308750 0
Ethics committee name [2] 308755 0
The University of Queensland's Human Research Ethics Committee
Ethics committee address [2] 308755 0
Ethics committee country [2] 308755 0
Australia
Date submitted for ethics approval [2] 308755 0
19/08/2021
Approval date [2] 308755 0
Ethics approval number [2] 308755 0
16/09/2021
Ethics committee name [3] 311350 0
Curtin University Human Research Ethics
Ethics committee address [3] 311350 0
Ethics committee country [3] 311350 0
Australia
Date submitted for ethics approval [3] 311350 0
01/12/2021
Approval date [3] 311350 0
08/12/2021
Ethics approval number [3] 311350 0
HRE2021-0760.

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

Contacts
Principal investigator
Name 111762 0
A/Prof Leanne Sakzewski
Address 111762 0
Queensland Cerebral Palsy and Rehabilitation Research Centre Level 6 Centre for Children's Health Research
62 Graham Street South Brisbane QLD 4101
Country 111762 0
Australia
Phone 111762 0
+61 7 3069 7345
Fax 111762 0
Email 111762 0
l.sakzewski1@uq.edu.au
Contact person for public queries
Name 111763 0
Natalie Dos Santos
Address 111763 0
Queensland Cerebral Palsy and Rehabilitation Research Centre Level 6 Centre for Children's Health Research
62 Graham Street South Brisbane QLD 4101
Country 111763 0
Australia
Phone 111763 0
+61 7 3069 7356
Fax 111763 0
Email 111763 0
n.dossantos@uq.edu.au
Contact person for scientific queries
Name 111764 0
Leanne Sakzewski
Address 111764 0
Queensland Cerebral Palsy and Rehabilitation Research Centre Level 6 Centre for Children's Health Research
62 Graham Street South Brisbane QLD 4101
Country 111764 0
Australia
Phone 111764 0
+61 7 3069 7345
Fax 111764 0
Email 111764 0
l.sakzewski1@uq.edu.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
The study team are available to collaborate with other research teams upon receipt of a reasonable request to access study data. Expressions of interest to access study data (all of the individual participant data collected during the trial), made out the Principal Investigator, Assoc. Prof. Leanne Sakzewski will be considered and the group level or individual level de-identi data could be shared as appropriate.
When will data be available (start and end dates)?
Data will be available on completion of Data collection - 31/12/2026. End date: 2027
Available to whom?
The study team are available to collaborate with other research teams upon receipt of a reasonable request to access study data.
Available for what types of analyses?
Expressions of interest to access study data, made out the Principal Investigator, Assoc. Prof. Leanne Sakzewski will be considered and the group level or individual level de-identified data could be shared as appropriate for IPD met-analyses.
How or where can data be obtained?
Expressions of interest to access study data, made out the Principal Investigator, Assoc. Prof. Leanne Sakzewski will be considered. Postal Address: Assoc. Prof. Leanne Sakzewski
UQ - Queensland Cerebral Palsy and Rehabilitation Research Centre (QCPRRC) Centre for Children’s Health Research Level 6, 62 Graham Street, South Brisbane Qld 4101 Australia E: l.sakzewski1@uq.edu.au


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
12058Informed consent form    382176-(Uploaded-22-02-2023-13-44-59)-Study-related document.docx
12183Other    Study Flyer 382176-(Uploaded-29-06-2021-15-34-01)-Study-related document.pdf



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
SourceTitleYear of PublicationDOI
EmbaseACTIVE STRIDES-CP: Protocol for a randomised trial of intensive rehabilitation (combined intensive gait and cycling training) for children with moderate-to-severe bilateral cerebral palsy.2023https://dx.doi.org/10.1136/bmjopen-2022-068774
N.B. These documents automatically identified may not have been verified by the study sponsor.