heROIC trial: Investigating the RRT in children with CP Version1.1
Research type
Research Study
Full title
heROIC trial: A prospective, single arm, pre-post trial to investigate whether quality of life (QOL), range of movement (ROM), spasticity and function, in children with cerebral palsy (GMFCS IV-V) can be affected using a robotic rehabilitation trainer (RRT) for 30 minutes, 4 times a week for 6 weeks.
IRAS ID
260371
Contact name
Clare Dorset-Purkis
Contact email
Sponsor organisation
Noclor on behalf of Whittington Health
ISRCTN Number
ISRCTN92095509
Duration of Study in the UK
1 years, 4 months, 7 days
Research summary
Summary of Research
This non-randomised controlled trial aims to investigate whether quality of life (QOL) in children with cerebral palsy (CP), who are unable to stand or walk unaided can change after using an Innowalk Pro (IP). It will be used for 30minutes 4x a week, over 6 weeks, using a convenience sample from a special school. The IP is a robotic rehabilitation trainer that allows users with significant physical disabilities to stand and move in an upright position that promotes weight-bearing. It provides assisted, guided and repetitive movements in a supported system, allowing for safe mobilisation. The primary outcome will measure QOL using the Caregiver Priorities and Child Health Index of Life with Disabilities (CPCHILD) which is a questionnaire to be filled in by parents/caregivers. Secondary outcomes (measured by a Physiotherapist)are:
-participant function using the Goal Attainment Scale (GAS)
-range of movement (ROM)in lower limbs (hip and knee extension, popliteal angle, and dorsiflexion of the ankle using a goniometer)
-spasticity of lower limb muscles (hamstrings, rectus femoris, gastrocnemius and soleus using the Modified Tardieu Scale(MTS))
Outcomes will be assessed before and after intervention and re-assessed at 6weeks and 3months after intervention. Through clinical practice it has been widely noted that children with significant physical impairments related to their CP often have issues with pain and physical wellbeing. Positioning and activity, has often helped to improve pain and wellbeing and is recommended by physiotherapists to reduce the severity of postural deformities and subsequent pain. Literature has found that there were strong associations in poorer parent-reported QoL in the domains of physical wellbeing for children with CP with higher severity of motor impairments. This study will attempt to show if the IP can be helpful in this population to improve overall QOL as reported by parents.Summary of Results
The results of this study suggest that a six-week course of the Innowalk Pro (four times a week for 30mins), can improve quality of life and functional goals for children with cerebral palsy aged 5-18 years, albeit with no clinically meaningful change in range of movement or spasticity. It also demonstrates that after a break of 6-12 weeks of using the Innowalk Pro, functional goals tend to return to baseline level and knee extension range could reduce. This is the first study in the UK to demonstrate these findings within a school setting.REC name
London - Camden & Kings Cross Research Ethics Committee
REC reference
19/LO/1721
Date of REC Opinion
28 Jan 2020
REC opinion
Further Information Favourable Opinion