Robot Therapy for Anxiety

(Canada-UK AI Trial)

Recruiting at 1 trial location

Overseen By Patricia Candelaria, BScN

Age: < 18

Sex: Any

Trial Phase: Academic

Sponsor: University of Alberta

Disqualifiers: Medically unstable, Unconscious, Neurocognitive delays, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 3

Duration: 1 day per participant

90 Participants Needed

Trial Summary

What is the purpose of this trial?

Children experience pain and distress in clinical settings every day. The negative consequences of unaddressed pain can be both short-term (e.g. fear, distress, inability to perform procedures) and long-term (e.g. needle phobia, anxiety). In previous small studies, a humanoid robot has been used to deliver cognitive-behavioural therapy during needle procedures. The results of these early studies have been positive, showing high acceptance among children as well as promising initial clinical results. However, these studies all had critical technical limitations: the robot was remotely operated and used purely scripted behaviour with limited Artificial Intelligence support. This reduced the potential to offer personalized support to children. In this project, the study team aims to address this limitation by developing and evaluating a clinically relevant and responsive artificial intelligence-enhanced social robot.

Will I have to stop taking my current medications?

The trial information does not specify whether participants need to stop taking their current medications.

What data supports the effectiveness of the Robot Therapy for Anxiety treatment?

Research on robot-assisted rehabilitation for stroke patients shows that these robots can help improve arm function by making exercises more engaging and providing feedback on progress. This suggests that similar robot therapy could be effective for anxiety by offering interactive and motivating tasks. ^{1 2 3 4 5}

Is robot therapy generally safe for humans?

Research on rehabilitation robots, including those for hand and upper limb therapy, shows they are generally safe for humans, with no significant adverse effects reported. Safety assessments focus on preventing excessive forces and ensuring movements stay within safe joint ranges. ^{5 6 7 8 9}

How does robot therapy for anxiety differ from other treatments?

Robot therapy for anxiety is unique because it uses a robot to assist in rehabilitation, providing a more interactive and engaging experience compared to traditional methods. This approach can offer repetitive and motivating tasks, such as games, and provide quantitative feedback on progress, which is not typically available in standard anxiety treatments. ^{1 2 3 5 10}

Eligibility Criteria

This trial is for children aged 5-11 years who need an intravenous injection (IVI) and will receive a topical anesthetic for it. It's designed to help kids who experience pain or distress during medical procedures like getting a shot.

Inclusion Criteria

My child is between 5 and 11 years old.

I need injections into my eye.

I will be given a local anesthetic for my injection.

Exclusion Criteria

Unconscious or not fully alert

Parental or child language barrier precluding the ability to understand and complete study assessments, in the absence of a native language translator

Not accompanied by legal guardian

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

1 visit (in-person)

Co-design and Usability

Development and evaluation of the AI-enhanced social robot with family input and research team collaboration

12 months

Treatment

Participants receive either standard of care or robot intervention during IV insertion

1 day per participant

1 visit (in-person)

Follow-up

Participants are monitored for satisfaction, fear, anxiety, and engagement immediately after the procedure

1 day

1 visit (in-person)

Treatment Details

Interventions

• Robot

Trial Overview The study is testing how well a humanoid robot can deliver cognitive-behavioral therapy to reduce anxiety and distress in children during needle procedures. The robot uses artificial intelligence to provide personalized support, improving upon previous models that had limited AI capabilities.

Participant Groups

Group I: Robot (Intervention) Experimental Treatment 1 Intervention

This arm will include the addition of robot distraction to current departmental standard of care. Distraction will include interaction with a socially intelligent, autonomous humanoid robot, the development of which will be informed by the other work packages.

Group II: Standard of Care (Control) Active Control 1 Intervention

This arm will include topical anesthetic as well as a combination of parental support, child life services and/or healthcare provider support, at the discretion of the treating team and family.

Robot is already approved in United States for the following indications:

Approved in United States as Motus Hand for:

• Stroke rehabilitation
• Upper limb motor recovery

Approved in United States as IpsiHand for:

• Stroke rehabilitation
• Upper limb motor recovery

Who Is Running the Clinical Trial?

University of Alberta

Lead Sponsor

Trials

957

Recruited

437,000+

University of Toronto

Collaborator

Trials

739

Recruited

1,125,000+

Findings from Research

Robot-aided rehabilitation for stroke patients offers a more intensive and engaging approach to restoring arm function, making repetitive exercises feel like games, which can enhance motivation and adherence to therapy.

The review highlights the effectiveness of various rehabilitation robots, showing positive clinical outcomes and usability in real-life applications, indicating their potential to significantly improve recovery in stroke patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A review of technological and clinical aspects of robot-aided rehabilitation of upper-extremity after stroke. Babaiasl, M., Mahdioun, SH., Jaryani, P., et al.[2017]

Robotic therapy using the Armeo® device shows a positive trend in improving upper limb rehabilitation for stroke patients when combined with conventional therapy, based on a review of six studies.

The studies reviewed highlight the need for further research due to limitations in quality, but the encouraging results suggest that Armeo® could be a valuable tool in stroke rehabilitation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Effectiveness of the Armeo ® device in the rehabilitation of the upper limb of stroke's patients. A review of the literature]. Yáñez-Sánchez, A., Cuesta-Gómez, A.[2021]

An international survey of 233 therapists revealed key preferences for a robotic device aimed at upper limb rehabilitation post-stroke, emphasizing the need for features like facilitating various arm movements and providing biofeedback.

Therapists indicated that the ideal robotic device should be user-friendly for seated patients, include virtual activities for daily living, be adjustable to individual needs, and cost under $6000 to enhance integration into clinical practice.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The development of an upper limb stroke rehabilitation robot: identification of clinical practices and design requirements through a survey of therapists. Lu, EC., Wang, RH., Hebert, D., et al.[2022]

In a study involving 39 stroke patients, robot-assisted rehabilitation using the MOTORE/Armotion haptic system led to significant improvements in motor recovery, as measured by various clinical assessments like the Fugl-Meyer Assessment and Box and Block Test.

Subacute stroke patients showed notable enhancements in multiple parameters, including mean speed and energy expenditure, while chronic stroke patients primarily improved in elbow spasticity, indicating that the haptic device is effective across different stages of stroke recovery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Upper limb robot-assisted therapy in subacute and chronic stroke patients using an innovative end-effector haptic device: A pilot study. Mazzoleni, S., Battini, E., Crecchi, R., et al.[2019]

A novel robot-assisted neuro-rehabilitation therapy for upper limbs was tested in a clinical trial with 30 stroke patients over three months, showing no adverse effects and good patient acceptance.

The therapy not only helps reduce muscular tension but also suggests that manipulating the impaired upper limb may positively influence brain recovery, highlighting its potential efficacy in rehabilitation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A novel robot neurorehabilitation for upper limb motion. Xiu-Feng, Z., Lin-Hong, J., Li-Yun, G.[2020]

A pilot study involving 12 stroke survivors with chronic moderate hemiparesis demonstrated that a new robotic device for hand rehabilitation is safe and well-tolerated, with no complications reported during the 6-week training program.

Participants showed significant improvements in motor performance across various assessments, indicating that robotic therapy could effectively enhance hand function in stroke survivors.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Robot-assisted exercise for hand weakness after stroke: a pilot study. Stein, J., Bishop, L., Gillen, G., et al.[2016]

A new validation toolkit was created to ensure the safety of rehabilitation robots by assessing risks related to moving a patient's upper limb beyond safe anatomical limits.

The toolkit includes a sensorized dummy limb and software for risk assessment, allowing for better monitoring of rehabilitation robots during operation to prevent injuries.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Testing the Limit Range of Motion Safety Function of Upper Limb Rehabilitation Robots with an Anthropometrically Adjustable and Sensorized Dummy Limb. Toth, A., Pilissy, T., Bauer, MO., et al.[2022]

The RobHand robotic exoskeleton is a safe rehabilitation tool for stroke patients, with no significant adverse events reported during the training sessions, and users expressed high satisfaction with its comfort and professional support.

Despite the positive safety and satisfaction outcomes, the study found no statistically significant improvements in manual function after 16 training sessions, likely due to the chronic stage of the stroke in the participants, suggesting that future research should focus on earlier intervention in subacute patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Hand rehabilitation based on the RobHand exoskeleton in stroke patients: A case series study. Barria, P., Riquelme, M., Reppich, H., et al.[2023]

The article proposes a uniform approach for assessing the safety of rehabilitation robots early in their development, focusing on safety skills that help mitigate specific risks during human-robot interactions.

Identifying excessive forces on soft tissue and musculoskeletal levels as key hazards, the authors suggest safety validation protocols that can be adapted across various applications, highlighting the need for reliable measurement methods and limit values for safe human-robot interactions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety Assessment of Rehabilitation Robots: A Review Identifying Safety Skills and Current Knowledge Gaps. Bessler, J., Prange-Lasonder, GB., Schaake, L., et al.[2021]

A pilot study involving 22 stroke patients and 11 occupational therapists demonstrated that a robotic system designed for muscle reeducation is safe and generally well-accepted by patients during rehabilitation sessions.

Therapists showed a qualified acceptance of the robotic system, indicating that while they see its potential, they also suggested modifications to enhance its utility in therapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Patient and staff acceptance of robotic technology in occupational therapy: a pilot study. Dijkers, MP., deBear, PC., Erlandson, RF., et al.[2022]

References

1. England pubmed.ncbi.nlm.nih.gov

A review of technological and clinical aspects of robot-aided rehabilitation of upper-extremity after stroke. [2017]

2. Spain pubmed.ncbi.nlm.nih.gov

[Effectiveness of the Armeo ® device in the rehabilitation of the upper limb of stroke's patients. A review of the literature]. [2021]

3. England pubmed.ncbi.nlm.nih.gov

The development of an upper limb stroke rehabilitation robot: identification of clinical practices and design requirements through a survey of therapists. [2022]

4. Netherlands pubmed.ncbi.nlm.nih.gov

Upper limb robot-assisted therapy in subacute and chronic stroke patients using an innovative end-effector haptic device: A pilot study. [2019]

5. United States pubmed.ncbi.nlm.nih.gov

A novel robot neurorehabilitation for upper limb motion. [2020]

6. United States pubmed.ncbi.nlm.nih.gov

Robot-assisted exercise for hand weakness after stroke: a pilot study. [2016]

7. United States pubmed.ncbi.nlm.nih.gov

Testing the Limit Range of Motion Safety Function of Upper Limb Rehabilitation Robots with an Anthropometrically Adjustable and Sensorized Dummy Limb. [2022]

8. Switzerland pubmed.ncbi.nlm.nih.gov

Hand rehabilitation based on the RobHand exoskeleton in stroke patients: A case series study. [2023]

9. Switzerland pubmed.ncbi.nlm.nih.gov

Safety Assessment of Rehabilitation Robots: A Review Identifying Safety Skills and Current Knowledge Gaps. [2021]

10. United States pubmed.ncbi.nlm.nih.gov

Patient and staff acceptance of robotic technology in occupational therapy: a pilot study. [2022]