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Trial registered on ANZCTR


Registration number
ACTRN12617001410347
Ethics application status
Approved
Date submitted
29/09/2017
Date registered
5/10/2017
Date last updated
10/09/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
What are the possible benefits of Robotic-Assisted Gait Training and how much training is needed: A pilot randomised clinical trial with children with Cerebral Palsy.
Scientific title
What is the effect of Robotic-Assisted Gait Training on self-perception of performance and participation, using the Canadian Occupational Performance Measure (COPM), and how much training is needed to determine change: a pilot randomised clinical trial with children with Cerebral Palsy.
Secondary ID [1] 293037 0
Nil Known
Universal Trial Number (UTN)
U1111-1202-6495
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Cerebral Palsy 304869 0
Condition category
Condition code
Neurological 304181 304181 0 0
Other neurological disorders
Physical Medicine / Rehabilitation 304289 304289 0 0
Physiotherapy

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Pilot 3-arm randomised controlled trial investigating the effects of Robotic-Assisted Gait Training (RAGT) in children with cerebral palsy (CP)
Arm 1: Six-week waitlist then random allocation into two or four (30-40 minute) RAGT sessions per week for six weeks.
Arm 2: two (30-40 minute) sessions of RAGT per week for six weeks
Arm 3: four (30-40 minute) sessions of RAGT per week for six weeks.
RAGT sessions: approximately 1 hour, with 30-40 minutes of this active 1:1 (individual) therapy using the Lokomat Pro in sessions conducted by the Robotics and Innovation Physiotherapist at the Women's and Children's Hospital. These sessions will be carried out at the Little Heroes Foundation Centre for Robotics and Innovation at the Women's and Children's Hospital. All sessions are conducted following the Hocoma Lokomat manual, and directions and session plans are created based on clinical reasoning by paediatric physiotherapists.
In the first session of the intervention blocks, pre-assessment data will be collected and recorded (approximately 1 hour) before an acclimatisation session in the Lokomat®Pro (30-40 minutes). Each subsequent intervention session will be 60 minutes long which will include around 10-20 minutes of heart rate and blood pressure measures, set up and fitting time, 30-40 minutes of active RAGT, and five minutes for completion of final assessments. During the active RAGT period, a range of avatar-based games and biofeedback information will be used to target different goals as determined by the COPM assessment. The three Lokomat® variables that will be adjusted regularly throughout sessions are treadmill speed, weight support and guidance force. These changes will be made subject to Borgs rating of percieved exertion scores being ideally 13. Treadmill speed would be increased, and weight support decreased if it appears the child requires an increased challenge or is progressing well between sessions. Guidance force is the amount of assistance the Lokomat® is providing the child to walk in the physiological gait pattern. This would be decreased to provide an additional challenge or as a motivational technique using the biofeedback charts. Throughout the RAGT sessions, children will be given feedback on progress as compared to previous sessions and achievements can be logged and shown in real time on the video screen. At the last intervention session, the post-assessments will be undertaken (approximately 1 hour). The assessments will be repeated six weeks after the intervention period.
Intervention code [1] 299209 0
Rehabilitation
Intervention code [2] 299279 0
Treatment: Devices
Comparator / control treatment
Arm 1 (control): Six week wait list then random allocation into two or four (30-40 minute) RAGT sessions per week for six weeks
Arm 2: two (30-40 minute) sessions of RAGT per week for six weeks
Arm 3: four (30-40 minute) sessions of RAGT per week for six weeks.
Control group
Active

Outcomes
Primary outcome [1] 303491 0
Change in Canadian Occupational Performance Measure (COPM)
Timepoint [1] 303491 0
pre-intervention, post-intervention and 6 week follow up.
Secondary outcome [1] 339064 0
Gross Motor Function Measure sections D and E (GMFM)
Timepoint [1] 339064 0
pre-intervention, post-intervention and 6 week follow up.
Secondary outcome [2] 339272 0
Standardised muscle circumference of thigh and calf (centimetres)
Timepoint [2] 339272 0
pre-intervention, post-intervention and 6 week follow up. Using a tape measure that will be used consistently throughout the protocol.
Secondary outcome [3] 339275 0
Borgs Rating of Perceived Exertion Scale (RPE)
Timepoint [3] 339275 0
To be asked every 10 minutes per session to indicate the level of exertion to determine the required change of Lokomat variables (rating of 13 ideal).
Secondary outcome [4] 339276 0
Australian Spasticity Assessment Scale (ASAS)
Timepoint [4] 339276 0
pre-intervention, post-intervention and 6 week follow up.
Secondary outcome [5] 339277 0
Range of motion of lower limbs;
Timepoint [5] 339277 0
pre-intervention, post-intervention and 6 week follow up. Taken using a goniometer. The same goniometer will be used throughout the protocol.
Secondary outcome [6] 339278 0
Selective motor control in lower limbs
Knee:
Position: Sitting
Ask the participant to extend, flex then extend the knee while keeping the hip flexed. For example: “Straighten your knee as much as you can, then bend it and straighten again. Try to do this without leaning further back or moving your other leg. I will take you
through the motion first, and then I’
d like you to do it yourself.”
Ankle:
Position: Sitting. The knee is extended and the examiner supports the calf. Assess passive ankle
dorsiflexion ROM with the knee extended. The knee may be flexed to approximately 20 degrees if needed to accommodate hamstring and/or
gastrocnemius tightness.
Instructions –
Ask participant to dorsiflex, plantar flex then dorsiflex the ankle while maintaining knee extension. For example:
“Keeping your knee straight while I support your leg, move your foot up, down then up again. I will take you through the motion first, then
I’d like you to do it yourself.”
Timepoint [6] 339278 0
pre-intervention, post-intervention and 6 week follow up.
Secondary outcome [7] 339279 0
Gross Motor Function Classification Scale (GMFCS)
Timepoint [7] 339279 0
pre-intervention, post-intervention and 6 week follow up.
Secondary outcome [8] 339280 0
Functional Mobility Scale
Timepoint [8] 339280 0
pre-intervention, post-intervention and 6 week follow up.
Secondary outcome [9] 339281 0
Two-minute walk test (2mwt)
Timepoint [9] 339281 0
pre-intervention, post-intervention and 6 week follow up. Will require a stopwatch and a tape measure to lay out a 20 metre path.
Secondary outcome [10] 339282 0
Cerebral Palsy Quality of Life Questionnaire (CP QOL-Child)
Timepoint [10] 339282 0
pre-intervention, post-intervention and 6 week follow up.
Secondary outcome [11] 339283 0
The Children’s Assessment of Participation and Enjoyment (CAPE)
Timepoint [11] 339283 0
pre-intervention, post-intervention and 6 week follow up.
Secondary outcome [12] 339362 0
Preferences for Activities of Children (PAC)
Timepoint [12] 339362 0
pre-intervention, post-intervention and 6 week follow up.

Eligibility
Key inclusion criteria
Inclusion Criteria:
•Children with a diagnosis of Cerebral Palsy
•GMFCS level of II-IV
•Aged 5 to 14 years
•Able to follow instructions, and to participate in a minimum of 45 min of active physical therapy
•Able to communicate pain, discomfort and report on perceived level of exertion
Minimum age
5 Years
Maximum age
14 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Exclusion Criteria:
•Body weight: less than 15kg or more than 135kg
•Femur length: less than 23cm or more than 47cm
•Unable to sustain vertical position for >20 minutes (orthostatic)
•Knee flexion contracture of >10°
•Knee valgus >40°
•Orthopaedic surgery <9 months for soft tissues and <18 months for lower limb bony surgery
•Botulinum Toxin (Type A) injection in the previous four months or planned during study period
•Uncontrolled seizure disorder
•Weight-bearing restrictions
•Pregnancy
•Behavioural problems/inability to offer consent in addition to guardian.

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 via third party not involved in recruitment
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
sequence is computer generated , and stratified to GMFM to ensure equal numbers of each level in each arm.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?

The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Other
Other design features
Participants are randomly allocated into three groups as described above. One group (arm 1) of participants will be assigned to 'waitlist' before allocation to two or four RAGT sessions per week for six weeks. A second group (arm 2) will receive two sessions of RAGT per week for six weeks. The third group (arm 3) will receive four sessions of RAGT per week for six weeks.
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
n=10
Multiple ANOVA tests to be conducted for COPM, GMFM and 2MWT to see the difference between groups.
A repeated measures ANCOVA will be used to compare the effects of the different intensities of RAGT.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
6/10/2017
Actual
6/11/2017
Date of last participant enrolment
Anticipated
3/02/2018
Actual
1/03/2018
Date of last data collection
Anticipated
30/06/2018
Actual
3/05/2018
Sample size
Target
10
Accrual to date
Final
5
Recruitment in Australia
Recruitment state(s)
SA
Recruitment hospital [1] 9102 0
Womens and Childrens Hospital - North Adelaide
Recruitment postcode(s) [1] 17601 0
5006 - North Adelaide

Funding & Sponsors
Funding source category [1] 297594 0
Charities/Societies/Foundations
Name [1] 297594 0
The Little Heroes Foundation
Country [1] 297594 0
Australia
Primary sponsor type
Hospital
Name
Women's and Children's Hospital
Address
72 King William Rd, North Adelaide SA 5006
Country
Australia
Secondary sponsor category [1] 296608 0
University
Name [1] 296608 0
The University of South Australia
Address [1] 296608 0
108 North Terrace, Adelaide SA 5001
Country [1] 296608 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 298685 0
Women's and Children's Health Network Human Research Ethics Committee
Ethics committee address [1] 298685 0
72 King William Road
North Adelaide 5006
South Australia
Ethics committee country [1] 298685 0
Australia
Date submitted for ethics approval [1] 298685 0
22/03/2017
Approval date [1] 298685 0
19/04/2017
Ethics approval number [1] 298685 0
HREC/16/WCHN/48

Summary
Brief summary
Gait disorders in children can result from a number of conditions including cerebral palsy (CP),
myelomeningocoele and traumatic brain injury. Such disorders can have a profound effect on the components of walking, as well as the functional participation of children in their home, school and other natural environments. Robotic-Assisted Gait Training (RAGT) is an emerging option in physical rehabilitation for adults and children with disorders impairing their ability to walk. RAGT devices such as the Lokomat®Pro support an individual on a treadmill while the robotic exoskeleton moves the lower limbs to simulate walking.
There have been positive results from the use of RAGT in adult spinal cord injury and stroke populations for improvement in gait speed and endurance; however, the outcomes were not always better than traditional physiotherapy. Currently, there is weak and inconsistent evidence that RAGT may benefit children with CP with recommendations that higher level research investigates the role and potential of RAGT in this population. Additionally, many studies have failed to consider the impact of RAGT on participation outcomes. A limitation of the current literature is that no study has investigated different training schedules (frequency and intensity) of RAGT in children with CP and there is no consensus on the best schedule to promote functional improvement. Therefore, this study aims to investigate how RAGT should be prescribed and its impacts on body structure and function, activity and participation domains of the ICF. This research has the potential to aid in the development of clinical practice guidelines for the use of RAGT in children with CP.

Aims of research
This project will pilot test robotically-assisted gait training (RAGT) in children with cerebral palsy to:
1. Establish the most effective dosage for RAGT in terms of a) frequency and b) intensity of session, to induce clinically meaningful improvement in lower limb functioning, (as measured by the outcome measure listed in 'procedures and measurement')
2. Establish the measurements of outcome that demonstrate the most improvement from baseline after treatment to capture relative effectiveness across the ICF domains.
Hypotheses:
1. In children with CP, we hypothesise that a relationship exists between increased intensity and/or frequency of RAGT sessions and clinically meaningful improvement in lower limb performance (on ICF outcome measures).
2. We hypothesise that the greatest change in outcome measures will occur in the group with the higher dosage of RAGT therapy.
Trial website
Trial related presentations / publications
Public notes
Attachments [1] 2092 2092 0 0
/AnzctrAttachments/373708-WCHN Ethics Approval.pdf (Ethics approval)
Attachments [2] 2094 2094 0 0
/AnzctrAttachments/373708-Lefmann, Russo and Hillier.pdf (Publication)

Contacts
Principal investigator
Name 77890 0
Miss Emma Lowe
Address 77890 0
c/o C7-66
University of South Australia, City East Campus, GPO Box 2471, Adelaide, SA, 5001
Country 77890 0
Australia
Phone 77890 0
+61458973642
Fax 77890 0
Email 77890 0
[email protected]
Contact person for public queries
Name 77891 0
Remo (Ray) Russo
Address 77891 0
Head of Research, Paediatric Rehabilitation Department
Women's and Children's Health Network
72 King William Road, North Adelaide SA 5006
Country 77891 0
Australia
Phone 77891 0
+61-8-8161-7220
Fax 77891 0
+61-8-8161-8488
Email 77891 0
[email protected]
Contact person for scientific queries
Name 77892 0
Remo (Ray) Russo
Address 77892 0
Head of Research, Paediatric Rehabilitation Department
Women's and Children's Health Network
72 King William Road, North Adelaide SA 5006
Country 77892 0
Australia
Phone 77892 0
+61-8-8161-7220
Fax 77892 0
+61-8-8161-8488
Email 77892 0
[email protected]

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