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

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

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12621000605897
Enrollment
20
Registered
2021-05-20
Start date
2021-05-25
Completion date
2023-06-30
Last updated
2022-11-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief 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.

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 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 pro

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.

Sponsors

Womens and Childrens Hospital
Lead SponsorHospital

Study design

Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Outcomes Assessor)

Eligibility

Sex/Gender
All
Age
5 Years to 17 Years
Healthy volunteers
No

Inclusion criteria

Diagnosed with cerebral palsy (CP). Gross Motor Function Classification System (GMFCS) Level I-IV. Dynamic hypertonia in lower limb muscles with functional impact not responsive to therapy input alone. Able to follow instructions, participate in 45 minutes of therapy. Able to communicate pain, perceived level of exertion.

Exclusion criteria

Body weight less than 15kg or greater than 135kg. Femur length less than 23cm or greater than 47cm. Unable to maintain standing >20minutes. Knee flexion contracture >15degrees. Knee valgus >40degrees. Orthopaedic surgery (lower limb) <9months (soft tissue); <18months (bony) Botulinum Toxin (type A) injection in past 4 months. Uncontrolled siezures. Weight-bearing restrictions. Behavioural problems. Requires serial casting.

Outcome results

None listed

Source: ANZCTR · Data processed: Sep 1, 2026