A pilot investigation of the safety, feasibility and efficacy of robotics-based rehabilitation in children and adolescents with cancer

Chief Investigator: Dr Michael Osborn

Funding Amount: $75,000

Recipient: Women’s and Children’s Health Network

Overview:

Cancer treatment is associated with significant physical deconditioning, resulting in impaired functioning, worse quality of life, fatigue and depression. Given that >80% of children with cancer will become long-term survivors, efforts to improve physical functioning are likely to have long-term benefit. Our recent research demonstrated that a structured exercise program accelerated recovery of physical fitness in adolescents and young adults post-cancer treatment. However, many patients are incapable of participating due to limb surgery or neuromuscular complications of treatment. Investigation of novel approaches, including rehabilitation robotics, is required for these young people to improve their physical functioning and quality of life.

Research Outcomes:

Researchers: Dr Michael Osborn, Morgan Atkinson, Chris Innes-Wong, Angela Tully, Cathy Pendegrast, A/Prof Ray Russo, A/Prof Carol Maher, Dr Luke Johnson, Dr Tom Goddard, Dr Maria Kirby

Research Completed: 2021

Research Findings: There is increasing evidence that exercise is associated with improved cardiovascular fitness following cancer therapy. However, some patients (eg those with brain tumours, bone tumours, or nerve injuries) may have physical restrictions preventing participation in conventional exercise programs. Our study demonstrated that robotic guided rehabilitation, using devices such as lokomat or armeo, is  safe, feasible and is  associated with improved physical fitness and functioning in children, adolescents  and young adults undergoing cancer treatment.

Key Outcomes:

Background and Study Aims:

Cancer and its treatment is associated with significant physical deconditioning. There is increasing evidence that exercise is associated with improved cardiovascular fitness following cancer therapy. However, some patient groups (eg those with brain tumours, sarcomas, and treatment-related peripheral neuropathy) may have physical restrictions preventing them from participating in conventional exercise programs. Robotic guided rehabilitation, using devices such as lokomat or armeo, may benefit such individuals.

The aim of this study was to determine the safety and feasibility of robotics-based rehabilitation in paediatric, adolescent and young adult {AVA) cancer patients, as well as conducting a preliminary evaluation of efficacy.

Study Outcomes

Safety:

  • Safety was assessed by recording the number and grade of adverse events and infections experienced during rehabilitation robotics sessions. No grade 3 or 4 adverse events occurred in the 21 patients enrolled in the study. There were 22 grade 1adverse events (minor) and two grade 2 (moderate) adverse events. No infections relating to robotics were recorded. Adverse events included: delayed onset muscle soreness, joint pain, minor bruising and nerve pain. Importantly, all adverse events were either minor or moderate in severity and did not lead to withdrawal from the study.

Feasibility:

  • Feasibility was objectively measured via program demand, adherence to the robotics intervention and participant/family perceptions.
  • Program demand: 34 potential participants were screened prior to eligibility assessment, with 6 potential participants excluded for the following reasons: treatment related (n=l), not medically cleared (n=2), ineligible (n=3). 28 patients were approached and invited to participate. Seven did not participate for the following reasons: consented to study and withdrew prior to baseline assessment (n=2), declined participation (n= 2), approached and lost to follow up (n=3). 21 participants consented to study. 16 of 21 participants {76%) completed the 6-week intervention with five withdrawals. Reasons for withdrawal included:  relapsed disease (n=2), not challenging enough (n=l), disinterested (n=l), Completed 11of 12 sessions and was unable to complete 6 week assessment due to COVID19 lockdown (n=l).
  • Adherence to the robotics rehabilitation was 83% {231 robotics sessions attended of the 276 prescribed).
  • Participants and families were invited to provide an overall rating from 1to 10 indicating their level of satisfaction with rehabilitation robotics. The average rating was 8.6/10. Participants were also invited to provide positive and negative feedback. Positive feedback included: “The games helped to motivate me,” “You can hardly tell you’re doing the exercise,” and “I was able to tolerate it even when I wasn’t feeling well.” Negative feedback included: “Games got repetitive,” “Usually on a Friday after robotics I’d have no energy  and be quite drained,” “Impact on time and juggling school,” and “Doing other activities made it difficult.”

Efficacy:

  • Participants demonstrated a median improvement in cardiopulmonary fitness of 2.1 ml/kg/min-1from baseline to 6-week assessment. Measures of gait efficiency such as the 6-minute walk test (6MWT) improved by an average of 49.5 metres and gait speed over ten metres improved by 0.7 seconds. Further, we were able to detect improvement in the Canadian Occupational Performance Measure {COPM), which rates self­ perception of performance and satisfaction in everyday living. Performance and satisfaction improved by 2.0 and 2.6 points respectively, indicating a positive change.

Conclusion We were able to demonstrate that rehabilitation robotics was safe (no serious adverse events, no withdrawals relating to adverse events) and feasible (high uptake, good adherence and high participant/family satisfaction scores). Further, we were able to detect an efficacy signal via improved cardiovascular fitness {V02 peak), measures of gait efficiency

Research Papers: Currently there are no publications or conference presentations on the results of this study. The study team is currently analysing data and preparing a manuscript to be published in an appropriate peer reviewed journal. Any conference or publication information will be forwarded to the Channel 7 Children’s Research Foundation for the specified period following the funding period.

Related Publications:

Future Outcomes:

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