RecruitingACTRN12621000605897

Can robotic technology assist children with cerebral palsy after botulinum toxin injection?

Sponsor

Womens and Childrens Hospital

Enrollment

30 participants

Start Date

May 25, 2021

Study Type

Interventional

Conditions

Lower limb hypertonia Equinus Cerebral Palsy Gait abnormalities

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.

Eligibility

Sex: Both males and femalesMin Age: 5 YearssMax Age: 17 Yearss

Plain Language Summary

Simplified for easier understanding

Children with cerebral palsy often have increased muscle stiffness (hypertonia) in their legs, which can affect how they walk and move. Botulinum toxin (commonly known as Botox) injections can temporarily relax these muscles, but the benefits may fade after a few months and repeated injections may cause muscle shrinkage over time. Robotic-assisted therapy — using a walking robot that guides the legs through correct movement patterns — may help prolong the effects of the injections by helping the nervous system learn better movement patterns. Your child may be eligible if they have cerebral palsy, are classified as GMFCS Level I to IV (meaning they can walk with or without support), have dynamic leg muscle stiffness that affects function, and can follow instructions and participate in 45-minute therapy sessions. Children who weigh under 15 kg, have had recent orthopaedic surgery, or cannot bear weight are not eligible. Participants are randomly assigned to robotic-enhanced therapy or conventional physiotherapy after their botulinum toxin injection. Researchers will compare how long the beneficial effects of the injection last, how much children enjoy the therapy, and whether it is cost-effective. The study is being run at the Women's and Children's Hospital in Adelaide.

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Interventions

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

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.