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Trial registered on ANZCTR


Registration number
ACTRN12617001439336
Ethics application status
Approved
Date submitted
5/10/2017
Date registered
11/10/2017
Date last updated
11/10/2017
Type of registration
Prospectively registered

Titles & IDs
Public title
Can robotic-assisted therapy help children with acquired brain injury?
Scientific title
What are the benefits of robotic-assisted rehabilitation compared to conventional therapy: A randomised controlled clinical trial in children with acquired brain injury.
Secondary ID [1] 292920 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Acquired brain injury 304806 0
Condition category
Condition code
Physical Medicine / Rehabilitation 304103 304103 0 0
Physiotherapy
Injuries and Accidents 304335 304335 0 0
Other injuries and accidents

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Robotic assisted therapy intervention arm.

Approx 1-1.5 hour individual therapy sessions, 3x week over a 5 week period. Treatments alternate between conventional therapy and robotic therapy during this period (15 sessions in total - 8 robotics and 7 conventional).

During robotic therapy sessions two robotic devices, the Armeo and Lokomat will be used. Armeo is designed to improve arm function and Lokomat to improve walking. These sessions will be administered by a senior physiotherapist who is an expert with the robotic devices. There will be 30-40 minutes of Lokomat and 20-30 minuntes of Armeo per session. They will be conducted at the Little Heroes Foundation Centre for Robotics and Innovation located in the Women's and Children's Hospital in Adelaide, South Australia. Participants will receive guidance and encouragement from therapists and get visual biofeedback from the devices and play virtual reality games.

Conventional sessions will consist of current standard-practice manual exercises overseen by a clinical expert paediatric physiotherapist for improving gait, balance and functional abilities. They will be one on one sessions of 30-45 minute duration. Exercises will be goal directed and chosen at the discretion of the treating physiotherapist from intervention areas including functional strengthening, isolated strengthening, gait training, cardio-respiratory training, balance/core exercises and motor skill learning. Exercises will progress in difficultly to remain challenging for each client and reviewed at the end of each week. Participants will receive encouragement from therapists and general verbal performance feedback in order to engage participants as much as possible and to increase their active participation and motivation.

There is a 6 week washout period between interventions.
Intervention code [1] 299160 0
Rehabilitation
Intervention code [2] 299324 0
Treatment: Devices
Comparator / control treatment
Conventional physiotherapy arm.

30-45 minute sessions, 3x week over a 5 week period. Treatments will all be conventional therapy during this period. Some sessions may be run by a student physiotherapist who is supervised by an expert paediatric physiotherapist. Treatment progression and exercise selection will be dine in consultation with the supervising expert physiotherapist.

Conventional sessions will consist of current standard-practice manual exercises overseen by a clinical expert paediatric physiotherapist for improving gait, balance and functional abilities. They will be one on one sessions of 30-45 minute duration. Exercises will be goal directed and chosen at the discretion of the treating physiotherapist from intervention areas including functional strengthening, isolated strengthening, gait training, cardio-respiratory training, balance/core exercises and motor skill learning. Exercises will progress in difficultly to remain challenging for each client and reviewed at the end of each week. Participants will receive encouragement from therapists and general verbal performance feedback in order to engage participants as much as possible and to increase their active participation and motivation.
Control group
Active

Outcomes
Primary outcome [1] 303431 0
Canadian Occupational Performance Measure (COPM)
Timepoint [1] 303431 0
Before and after each treatment arm and at 3 months post last intervention.
Secondary outcome [1] 338906 0
Hip torque in Newton Metre assessed by Lokomat force sensors
Timepoint [1] 338906 0
At the beginning and end of the robotic therapy arm.
Secondary outcome [2] 338908 0
2 minute walk test
Timepoint [2] 338908 0
Before and after each treatment arm and at 3 months post last intervention.
Secondary outcome [3] 338909 0
10 metre walk test
Timepoint [3] 338909 0
Before and after each treatment arm and at 3 months post last intervention.
Secondary outcome [4] 338911 0
Box and block test.
Timepoint [4] 338911 0
Before and after each treatment arm and at 3 months post last intervention.
Secondary outcome [5] 338912 0
Resting heart rate by oximeter.
Timepoint [5] 338912 0
Before and after each treatment arm and at 3 months post last intervention.
Secondary outcome [6] 338914 0
Questionnaire - specifically written by study authors about perceived benefits and barriers of the treatment.
Timepoint [6] 338914 0
At the completion of each 5 week intervention block.
Secondary outcome [7] 338916 0
Pediatric Quality of Life inventory.
Timepoint [7] 338916 0
Before and after each treatment arm and at 3 months post last intervention.
Secondary outcome [8] 339590 0
Range of motion of lower limbs - straight leg raise, Thomas test, dorsiflexion. Measured in supine with a goniometer.
Timepoint [8] 339590 0
Before and after each treatment arm and at 3 month follow up.
Secondary outcome [9] 339591 0
Overall perception of exertion - measured using Borgs Rating.
Timepoint [9] 339591 0
Recorded during each treatment session.
Secondary outcome [10] 339592 0
Functional mobility scale
Timepoint [10] 339592 0
Before and after each treatment arm and at 3 month follow up.
Secondary outcome [11] 339593 0
Gross motor function classification system (GMFCS).
Timepoint [11] 339593 0
At baseline assessment for randomisation.
Secondary outcome [12] 339653 0
Resting blood pressure by oximeter.
Timepoint [12] 339653 0
Before and after each treatment arm and at 3 months post last intervention.
Secondary outcome [13] 339654 0
Knee torque in Newton Metre assessed by Lokomat force sensors
Timepoint [13] 339654 0
At the beginning and end of the robotic therapy arm.

Eligibility
Key inclusion criteria
- Limitations in gross motor functioning resulting from an acquired brain injury (ABI)
- Diagnosis of ABI in paediatric age and adolescence (4-18 years)
- Had sustained the ABI 12 months prior to recruitment.
- Participant has both upper and lower limb functional goals
- Femur length greater than 21cm and upper arm greater than 16cm
- Able to fit to both arm and leg orthosis
- Able to comprehend and follow instructions for robotic therapy
- Ability to signal pain/fear/discomfort to therapist
Minimum age
4 Years
Maximum age
18 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- Contraindications to the Lokomat or Armeo and/or participation requirements (pregnant, orthopaedic, language, cognitive or behavioural impairments)
- severe contractures, fractures, osseous instabilities and osteoporosis
- Open skin lesions on extremities
- Aggressive or self-harming behaviour
- Neurological or cognitive-behavioural deficit/impairment manifested before the ABI event

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)
Potential subjects approached by researcher (from referral list); allocated to treatment by third party independent of recruitment.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Stratified allocation - Gross motor functional classification system (GMFCS). Randomisation schedule from computer generated sequence.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
Intervention assignment
Crossover
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Analyses will be on an intention-to-treat basis using SPSS 22 (SPPS inc. Chicago , IL). Means and medians (95% confidence intervals [CI]) will be calculated according to the data distribution. Comparisons between groups for categorical variables will use the Chi squared or Fisher's exact test. For group comparisons of continuous variables, the independent sample t test or the Mann-Whitney U test will be used.

The difference between means for the performance component of the primary outcome (COPM) is 2.1 and the SD is 1.3. The minimum clinically significant change for the COPM is 2 units on the measure. A significance level of .05 p-value will be used throughout.

Based on the above and work from Koele et al, (2014) , the COPM performance component needs a difference of means of 2.1 and the SD 1.3, giving ratio (2.1/1.3 = 1.6 approximately) which corresponds to a sample size of 21 (or 24 allowing for attrition). Therefore, we are allocating 12 participants to each group powered at 80% with a p<0.05.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
16/10/2017
Actual
Date of last participant enrolment
Anticipated
30/10/2017
Actual
Date of last data collection
Anticipated
22/02/2019
Actual
Sample size
Target
24
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
SA
Recruitment hospital [1] 9090 0
Womens and Childrens Hospital - North Adelaide
Recruitment postcode(s) [1] 17584 0
5006 - North Adelaide

Funding & Sponsors
Funding source category [1] 297550 0
Charities/Societies/Foundations
Name [1] 297550 0
Women's and Children's Hospital Foundation
Country [1] 297550 0
Australia
Primary sponsor type
Hospital
Name
Women's and Children's Hospital
Address
72 King William Road, North Adelaide
Country
Australia
Secondary sponsor category [1] 296560 0
University
Name [1] 296560 0
University of South Australia
Address [1] 296560 0
Frome Road, Adelaide, SA 5000
Country [1] 296560 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 298645 0
Women's and Children's Health Network Human Research Ethics Commitee
Ethics committee address [1] 298645 0
72 King William Road, North Adelaide, 5009
Ethics committee country [1] 298645 0
Australia
Date submitted for ethics approval [1] 298645 0
21/11/2016
Approval date [1] 298645 0
18/04/2017
Ethics approval number [1] 298645 0
HREC/16/WCHN/189

Summary
Brief summary
This study is looking at whether the use of robotic technology can assist youth with acquired brain injury function better in their lives. This is important because we know from previous studies that functional improvements in brain injury, such as better walking, can come from more intensity of therapy (doing lots of therapy). Robotic technology may be a fun way to provide this therapy to young people. Based on studies in people with neurological conditions it is felt that the technology could assist, but further studies are needed to determine whether this is true. This study is being conducted to assist in answering that question.

This study will involve two robotic machines - the Lokomat and the Armeo. The Lokomat is a robotic device to assist with walking and endurance. You/your child will be fitted to the device and while using it have the opportunity to engage with the interactive software used for fun and motivation. The Armeo is an upper limb robotic device that allows for practice of upper limb (arm and hand) skills, movement and strengthening. This device is connected to computer graphics with games and activities to motivate you/your child to complete activities. They allow for repetitive functional movements with instant feedback and the user practices these movement skills in virtual reality games. They are both located in the Little Heroes Foundation Centre for Robotics and Innovation at the Women's and Children's Hospital.

Initially you/your child will be randomly allocated to one of two treatment groups: robotic therapy or conventional physiotherapy (usual land-based physiotherapy). Then, after a 6 week break, will be crossed over into the other group for the second treatment block. All participants therefore get to experience both robotic and conventional physiotherapy. In each treatment group you/your child will receive 15 training (therapy) sessions in total over a 5 week period. Each training session should take approximately 1 hour to complete. There is a series of assessments (muscle length, walking speed, walking endurance etc) that will be conducted by an assessment physiotherapist before and after treatment blocks and at a 3 month follow up. We expect these to take about 1 hour each time.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 77758 0
Mr Chris Innes-Wong
Address 77758 0
Women's and Children's Hospital
72 King William Road,
North Adelaide, 5006.
Country 77758 0
Australia
Phone 77758 0
+61 8 8161 7000
Fax 77758 0
Email 77758 0
[email protected]
Contact person for public queries
Name 77759 0
Chris Innes-Wong
Address 77759 0
Women's and Children's Hospital
72 King William Road,
North Adelaide, 5006.
Country 77759 0
Australia
Phone 77759 0
+61 8 8161 7000
Fax 77759 0
Email 77759 0
[email protected]
Contact person for scientific queries
Name 77760 0
Remo (Ray) Russo
Address 77760 0
Women's and Children's Hospital
72 King William Road,
North Adelaide, 5006
Country 77760 0
Australia
Phone 77760 0
+61 8 8161 7000
Fax 77760 0
Email 77760 0
[email protected]

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No Supporting Document Provided



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