Does the use of a robotic rehabilitation trainer change quality of life, range of movement and function in children with cerebral palsy?

Plain English summary of protocol

Background and study aims
Current recommendations suggest that all children should access participate in about 60 minutes of moderate to vigorous exercise per day to improve overall health and quality of life. This includes children with a disability such as cerebral palsy (CP), which is the most common physical disability in childhood, occurring in 1 in 500 live births. However, moderate to vigorous exercise is particularly challenging in children with CP classified as Gross Motor Function Classification System (GMFCS) level IV or V, who are unable to walk or stand without aid or equipment. As a result, children with CP (GMFCS levels IV or V) are more likely to be predominantly sedentary (inactive), leading to negative health outcomes.
Robot-assisted therapies, such as the Innowalk Pro (IP), have evolved over the last 15 years and are increasing equity of access to therapy since they include adjustable settings to account for differences in range of movement, tone, and functional ability. Emerging evidence suggests improvements in quality of life from using robot-assisted devices, reported by both parents and patients. A robotic rehabilitation trainer (RRT) allows patients with severe physical disability to stand and move in an upright position with natural weight-bearing. It provides assisted, guided, and repetitive movements, giving the user flexibility in adjustment and support, allowing for mobilisation with high intensity. The aim of this study is to explore the effects of the Innowalk on quality of life, as reported by parents.

Who can participate?
Students who attend a special school in London, aged 5-18 years, with cerebral palsy and who are unable to stand or walk unaided

What does the study involve?
All participants in the study will receive their usual level of physiotherapy care before during and after the trial is completed, this includes the use of standing frames/walkers/direct physiotherapy sessions as needed, and this will not change due to them being involved in the study.
Participants' quality of life is assessed up to 5 days before they start using the RRT. The students will be assessed before the trial begins to assess the set up for each child which will be carried out by the physiotherapist, this requires measurements of the length of knee crease to the sole of the foot, and the height of the student to be taken. Measurements are taken on the day of the trial before the participants begin using the RRT by a trained member of the research team.
Each participant will receive the intervention of using the RRT for 30 minutes a day, 4 times a week for 6 weeks. The RRT has a tablet which will record the time each participant has spent using the equipment, what angle they stood at, how far they technically travelled in metres and the participants’ satisfaction when using it using a four-point scale of smiley faces – sad, indifferent, happy and very happy. This is recorded at the end of every session the participant has using the equipment. If the desired 30 minutes using the RRT is not reached for a reason this will be recorded.
On the final day of using the RRT, within an hour after completing the session of 30 minutes; all measurements will be repeated by a physiotherapist within 1 hour. Quality of life will also be assessed again within 2 days of the participants completing the intervention.
All assessments will then be repeated 6 weeks and 3 months following the completion of the intervention. Once the intervention is completed there will be no change in the provision of physiotherapy within the school to what they normally receive and therefore they will receive their usual standard of care.

What are the possible benefits and risks of participating?
The intervention of using the Innowalk Pro is not perceived to involve higher risk than what is known from their usual physiotherapy treatment as it offers movement through their available range of movement of their lower limbs.
It is important to note that although there have been no reports of this to the researchers' knowledge, if a child has a diagnosis of brittle bones or low bone density there is a potential risk of fracture. This is only a precaution, and each child will be closely monitored throughout the study.
Another risk is a potential for friction/pressure areas around areas of contact on the Innowalk, for example the shins and feet. This will be checked regularly to try and minimise risk.
There is a risk that any child may experience some pain or discomfort using the Innowalk. This will be monitored for very closely and if there are any signs of pain or discomfort, the use of it will be stopped immediately and reviewed by a physiotherapist. If once it has been reviewed by the physiotherapist and the child continues to experience pain or discomfort, they will cease to continue with the trial. If this is the case data will still be collected up until that point.
Smaller studies have shown some positive effects of using the Innowalk, such as improved range of movement, but this cannot be generalised to every child.
By consenting to participate in this study means each child will have access to the Innowalk Pro which will allow them to experience movement and time out of their chair for 30 minutes more than their usual postural program four times a week for 6 weeks.
Each child taking part in the study will be adding to evidence around the best use of the Innowalk. If benefits are evidenced through the research, these benefits are likely to also be experienced by other children with cerebral palsy as a consequence of its discovery.

Where is the study run from?
Whittington Health NHS Trust (UK)

When is the study starting and how long is it expected to run for?
August 2018 to October 2021

Who is funding the study?
Investigator initiated and funded

Who is the main contact?
Clare Grodon
clare.grodon@nhs.net

Contact information

Study information

Eligibility

Locations

Countries of recruitment

• England
• United Kingdom

Study participating centre

Sponsor information

Whittington Health NHS Trust
Hospital/treatment centre

Noclor Research Support Service
1st Floor, Bloomsbury Building
St Pancras Hospital
4 St Pancras Way
London
NW1 0PE
England
United Kingdom

Phone	+44 (0)20 7450 8507
Email	sponsor.noclor@nhs.net
Website	https://www.noclor.nhs.uk/request
"ROR"	https://ror.org/02vg92y09

Funders

Funder type

Other

Results and Publications

Study outputs

Additional files

41073_PIS_V1.1_18Dec19_Parent.pdf

Parent

41073_PIS_V1.1_18Dec19_Child.pdf

Child

ISRCTN92095509_PROTOCOL_V1.1_18Dec19.pdf

ISRCTN92095509_BasicResults 21Dec2022.pdf

Editorial Notes

22/12/2022: The basic results have been uploaded to the trial outputs table.
07/09/2022: The following changes have been made:
1. The public title has been changed from “Does the use of a robotic rehabilitation trainer improve quality of life, range of movement and functional goals in children with cerebral palsy?” to “Does the use of a robotic rehabilitation trainer change quality of life, range of movement and function in children with cerebral palsy?”
2. The intention to publish date has been changed from 01/09/2022 to 09/01/2023.
3. The principal investigator's contact details have been changed.
17/08/2022: Protocol file uploaded.
01/04/2022: added CPMS number to Protocol /serial number field.
18/03/2022: The principal investigator's contact details have been changed.
09/02/2022: Trial's existence confirmed by the London - Camden and Kings Cross Research Ethics Committee.