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Trial registered on ANZCTR


Registration number
ACTRN12621000605897
Ethics application status
Approved
Date submitted
1/03/2021
Date registered
20/05/2021
Date last updated
11/11/2022
Date data sharing statement initially provided
20/05/2021
Type of registration
Prospectively registered

Titles & IDs
Public title
Can robotic technology assist children with cerebral palsy after botulinum toxin injection?
Scientific title
Can robotic technology assist children with cerebral palsy after botulinum toxin injection?
Secondary ID [1] 303341 0
EOI Ref No: 12711200 (Channel 7 Children's Research Foundation)
Universal Trial Number (UTN)
U1111-1264-8729
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Cerebral Palsy 320591 0
Lower limb hypertonia 320592 0
Gait abnormalities 320606 0
Equinus 320607 0
Condition category
Condition code
Physical Medicine / Rehabilitation 318449 318449 0 0
Physiotherapy
Neurological 318450 318450 0 0
Other neurological disorders
Musculoskeletal 319188 319188 0 0
Other muscular and skeletal disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Robotic enhanced therapy program (starting 1-2 weeks after lower limb botulinum toxin administration). Participants will undertake individual, one hour Physiotherapy-led sessions twice a week for six weeks (twelve sessions total). One session per week on the Lokomat® Pro Robotic Gait Orthosis (50% of program) face-to-face at the Hospital, and one session per week of land based therapy (50% of program) either face-to-face at the Hospital or, if required, through Telehealth. Telehealth will be provided as an option if 1. it is clinically safe and appropriate, 2. the participant can otherwise not attend the session and 3. it is <50% of their program. The participants will be provided with an information sheet which details the nature of the intervention - the specific components and requirements - and consent form.
The Lokomat® Pro is a robotic gait orthosis to support a participant on a treadmill. The robotic exoskeleton provides specific guidance of the hip, knee and ankle movements to facilitate a physiological walking pattern. The device is completely programmable and can assist with tactile, visual and auditory feedback for the participant and allow for many repetitions of a typical gait pattern. Games enhance motivation and a visual display allows participants to track their progress. The aim of the Lokomat is to hit targets that are known to be critical elements of functional improvement.
A typical Lokomat® session includes set up (10 minutes), facilitated walking for 30-45 minutes, with standing rest breaks as required. A child’s program will be individualised based on their objective measures, goals and functional level. Lokomat® sessions could include activities that target symmetrical step length, increased step height, reduced body weight support (increased load), movement control or increased pace.
A typical land based session includes 45-60 minutes of activity based rehabilitation and is standard practice at the unit. The land based session is individualised and based on a child’s objective measures, goals and functional status. A typical session may include activities such as strengthening (lower limb and core), balance activities, gait re-education and practicing improved movement patterns (in walking, running or sports activities).
Sessions will be overseen by a Physiotherapist to ensure all treatment sessions are clinically appropriate.
Session attendance will be logged, and session notes maintained, as per usual Physiotherapy practice.
There will be no botulinum toxin administration during the 6 week treatment period in accordance with our research questions and aim.
Intervention code [1] 319650 0
Rehabilitation
Intervention code [2] 319658 0
Treatment: Drugs
Comparator / control treatment
Conventional therapy program (starting 1-2 weeks after lower limb botulinum toxin administration). Participants will undertake individual, one hour Physiotherapy-led sessions twice a week for six weeks (twelve sessions total). All sessions will be land based therapy either face-to-face at the Hospital or, if required, through Telehealth. Telehealth will be provided as an option if 1. it is clinically safe and appropriate, 2. the participant can otherwise not attend the session and 3. it is <50% of their program. The participants will be provided with an information sheet detailing the nature of the therapy and any considerations, and consent form.
A typical land based therapy session includes 45-60 minutes of activity based rehabilitation and is standard practice at the unit. The land-based session is individualised and based on a child’s objective measures, goals and functional status. A typical session may include activities such as strengthening (lower limb and core), balance activities, gait re-education and practicing improved movement patterns (in walking, running or sports activities).
Sessions will be overseen by a Physiotherapist to ensure all treatment sessions are clinically appropriate.
Session attendance will be logged, and session notes maintained, as per usual Physiotherapy practice.
There will be no botulinum toxin administration during the 6 week treatment period in accordance with our research questions and aim.
Control group
Active

Outcomes
Primary outcome [1] 326409 0
Duration of effect. Time (in days) from botulinum toxin injection to functional deterioration that necessitates re-injection, assessed using Goal Attainment Scaling (GAS) responses from weekly text messages. A GAS score of -1 or below is considered functional deterioration.
Timepoint [1] 326409 0
Weekly, from week 1 after injection until 'time-to-event'. 'Time-to-event' will vary for the individual post-injection.
Secondary outcome [1] 391392 0
Lower limb muscle tone as assessed by Modified Tardieu Scale.
Timepoint [1] 391392 0
Baseline, and at 1 month, 3 month, 6 month, and at 'time-to-event' after Botulinum toxin injection.
Secondary outcome [2] 391393 0
Walking endurance as assessed by 2 minute walk test (measured via video).
Timepoint [2] 391393 0
Baseline, and at 3 month, 6 month, and at 'time-to-event' after Botulinum toxin injection.
Secondary outcome [3] 391394 0
Gross motor function as measured by the Gross Motor Function Measure GMFM-66 standing and walking (D&E) sub-sections .
Timepoint [3] 391394 0
Baseline, and at 3 month and 6 month after Botulinum toxin injection.
Secondary outcome [4] 391396 0
Quality of life as assessed by the Cerebral Palsy Quality Of Life Questionnaire (Child or Teen).
Timepoint [4] 391396 0
Baseline, and at 6 months after Botulinum toxin injection.
Secondary outcome [5] 392224 0
Self-perception of functional performance as measured by Canadian Occupational Performance Measure (COPM).
Timepoint [5] 392224 0
Baseline, and at 3 month and 6 month after Botulinum toxin injection.
Secondary outcome [6] 393821 0
Selective motor control at ankle as assessed by Selective Motor Control measure.
Timepoint [6] 393821 0
Baseline, and at 1 month, 3 month, 6 month and 'time-to-event' after Botulinum toxin injection.
Secondary outcome [7] 393836 0
Gait speed as measured by 10 metre walk test (measured via video).
Timepoint [7] 393836 0
Baseline, and at 3 month and 6 month after botulinum toxin injection
Secondary outcome [8] 393837 0
An economic evaluation, as assessed by the the Child Health Utility 9-D (a preference based instrument for estimation of quality adjusted life years for the economic evaluation of health care treatment of young people).
Timepoint [8] 393837 0
Baseline, and at 6 month and 12 month after botulinum toxin injection .
Secondary outcome [9] 394367 0
Lower limb muscle tone as measured by the Australian Spasticity Assessment Scale (ASAS).
Timepoint [9] 394367 0
Baseline and at 1 month, 3 month, 6 month and at 'time-to-event' after Botulinum toxin injection.
Secondary outcome [10] 394368 0
Joint range of motion using a goniometer to measure ankle dorsiflexion (with knee extended), popliteal angle and hip abduction (with hip extended) range.
Timepoint [10] 394368 0
Baseline, and at 1 month, 3 month, 6 month and at 'time-to-event' after Botulinum toxin injection.

Eligibility
Key inclusion criteria
Diagnosed with cerebral palsy (CP).
Gross Motor Function Classification System (GMFCS) Level I-IV.
Dynamic hypertonia in lower limb muscles with functional impact not responsive to therapy input alone.
Able to follow instructions, participate in 45 minutes of therapy.
Able to communicate pain, perceived level of exertion.
Minimum age
5 Years
Maximum age
17 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Body weight less than 15kg or greater than 135kg.
Femur length less than 23cm or greater than 47cm.
Unable to maintain standing >20minutes.
Knee flexion contracture >15degrees.
Knee valgus >40degrees.
Orthopaedic surgery (lower limb) <9months (soft tissue); <18months (bony)
Botulinum Toxin (type A) injection in past 4 months.
Uncontrolled siezures.
Weight-bearing restrictions.
Behavioural problems.
Requires serial casting.

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)
Allocation will involve contacting the holder of the allocation schedule who is “off-site”.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a randomisation table created by computer software - 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
Currently re-injection interval varies but is typically six months. An increase of 25% would be judged as being clinically meaningful. Based on this proportion, assuming a power of 80%, p<0.05 and attrition, it was calculated that 15 participants per group are required (30 participants total).
Data will be maintained in a locked filing cabinet at the Women’s and Children’s Hospital, entered manually and a random selection of 5% will be checked for accuracy. Analyses will be performed using SPSS or STATA under an “intention to treat” approach. Quantitative data will be subject to descriptive analyses and parametric/non-parametric statistics according to data distribution. Independent samples t-test, Mann Whitney U test and the Chi squared test of association will be used to test for differences in baseline characteristics by treatment group. To test for the effect of the intervention on key outcomes, statistical analysis will examine gain scores in the primary and secondary outcome measures and utilise analysis of covariance (ANCOVA) to reduce errors due to variance in the data. Also, generalised linear models using a generalised estimating equation approach will be fitted. The effects of time to follow-up and treatment will be tested and planned comparison introduced into the model to test for effects at the key follow-up dates.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
2/06/2021
Actual
25/05/2021
Date of last participant enrolment
Anticipated
30/06/2023
Actual
Date of last data collection
Anticipated
31/12/2023
Actual
Sample size
Target
30
Accrual to date
14
Final
Recruitment in Australia
Recruitment state(s)
SA
Recruitment hospital [1] 18576 0
Womens and Childrens Hospital - North Adelaide
Recruitment postcode(s) [1] 32949 0
5006 - North Adelaide

Funding & Sponsors
Funding source category [1] 307758 0
Charities/Societies/Foundations
Name [1] 307758 0
Channel 7 Children's Research Foundation
Country [1] 307758 0
Australia
Primary sponsor type
Hospital
Name
Womens and Childrens Hospital
Address
72 King William Rd, North Adelaide SA 5006
Country
Australia
Secondary sponsor category [1] 308546 0
University
Name [1] 308546 0
University of South Australia
Address [1] 308546 0
City East Campus, 101 Currie St, Adelaide SA 5001
Country [1] 308546 0
Australia
Other collaborator category [1] 281640 0
University
Name [1] 281640 0
Flinders University
Address [1] 281640 0
Flinders University, Matthew Flinders Fellow College of Nursing and Health Sciences, Flinders University, Sturt Road, Bedford Park South Australia 5042
Country [1] 281640 0
Australia
Other collaborator category [2] 281641 0
University
Name [2] 281641 0
Adelaide University
Address [2] 281641 0
Adelaide University, Floor/Room WS8068.01, Adelaide University, Adelaide Health and Medical Sciences, North Terrace Adelaide SA 5000
Country [2] 281641 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 307779 0
Women's and Children's Health Network Human Research Ethics Committee
Ethics committee address [1] 307779 0
72 King William Road, North Adelaide SA, 5006
Ethics committee country [1] 307779 0
Australia
Date submitted for ethics approval [1] 307779 0
25/02/2020
Approval date [1] 307779 0
18/01/2021
Ethics approval number [1] 307779 0

Summary
Brief summary
Botulinum toxin to treat lower limb hypertonia has been shown to benefit children with cerebral palsy when coupled with therapy. There is little consensus on the details of the therapy regimes. There is concern about the potential effects for the Botulinum toxin to produce significant atrophy in the muscle, felt to be related to repeated injections. Efforts to limit the number of injection episodes by prolonging the effects of the toxin should be explored. This study aims to investigate if the duration of effect of Botulinum toxin injection in the legs of children with cerebral palsy differ with robotic-enhanced therapy compared to conventional therapy. The study will also investigate whether robotic-enhanced therapy is judged to be more or less engaging and fun for participants, and if it is cost effective.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 108470 0
A/Prof Remo (Ray) Russo
Address 108470 0
Women's and Children's Hospital, 72 King William Road, North Adelaide, SA 5006
Country 108470 0
Australia
Phone 108470 0
+61 08 81617000
Fax 108470 0
Email 108470 0
[email protected]
Contact person for public queries
Name 108471 0
Angela Tully
Address 108471 0
Women's and Children's Hospital, 72 King William Road, North Adelaide, SA 5006
Country 108471 0
Australia
Phone 108471 0
+61 08 81617000
Fax 108471 0
Email 108471 0
[email protected]
Contact person for scientific queries
Name 108472 0
Angela Tully
Address 108472 0
Women's and Children's Hospital, 72 King William Road, North Adelaide, SA 5006
Country 108472 0
Australia
Phone 108472 0
+61 08 81617000
Fax 108472 0
Email 108472 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


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
11431Other    Table of Assessments 381353-(Uploaded-21-04-2021-16-13-20)-Study-related document.pdf



Results publications and other study-related documents

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