Gamification of Neurorehabilitation-centric Hand Exercises Post Stroke or Brain Injury

NCT ID: NCT05547217

Last Updated: 2023-04-03

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 8 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-09-19
• Study Completion Date: 2023-09-19

Brief Summary

Stroke is the leading cause of adult disability worldwide. Often, severe neurological deficits occur after a stroke and roughly 70% of all stroke survivors have some form of hand function disability. To improve the lives of those with hand function disability, IRegained Inc. has created the MyHandTM System. The MyHandTM System is a smart-mechatronic device programmed with proprietary hand function training regiments (protocols) based on deep research in neuroplasticity. It provides a highly unique and targeted approach to hand function rehabilitation with the help of the aforementioned protocols delivered with gamified training techniques. The gamified format of the protocols allows for better patient engagement, thus allowing for more effective and efficient therapy. Individuals who have sustained a stroke 5 months or earlier (considered to be chronic stroke survivors) will be eligible to participate in this study. Participants will undergo a 2-hour training session, 2-3 days per week, over 12 weeks, for a total of 30 sessions. Hand function therapy will be administered in a specific and gamified manner to enhance rehabilitation of the hand and provide participants with greater opportunity to regain hand function over the course of the study. The goal of this research project is to understand how a gamified approach to hand function rehabilitation impacts engagement and motivation. This understanding will directly translate into the development of more efficient and effective modes of therapy.

Conditions

Stroke; Engagement, Patient

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Neurorehabilitation of the Hand

Participants will undergo a 2-hour training session, 2-3 days per week, over 12 weeks, for a total of 30 sessions. Hand function therapy will be administered in a specific and gamified manner to enhance rehabilitation of the hand and provide participants with greater opportunity to regain hand function over the course of the study.

Group Type: EXPERIMENTAL

Hand Therapy using the MyHand System

Intervention Type: DEVICE

The MyHandTM System is a smart-mechatronic device programmed with proprietary hand function training regiments (protocols) based on deep research in neuroplasticity. It provides a highly unique and targeted approach to hand function rehabilitation with the help of the aforementioned protocols delivered with gamified training techniques. The gamified format of the protocols allows for better patient engagement, thus allowing for more effective and efficient therapy. Participants will undergo a 2-hour training session, 2-3 days per week, over 12 weeks, for a total of 30 sessions. Hand function therapy will be administered in a specific and gamified manner to enhance rehabilitation of the hand and provide participants with greater opportunity to regain hand function over the course of the study.

Interventions

Hand Therapy using the MyHand System

The MyHandTM System is a smart-mechatronic device programmed with proprietary hand function training regiments (protocols) based on deep research in neuroplasticity. It provides a highly unique and targeted approach to hand function rehabilitation with the help of the aforementioned protocols delivered with gamified training techniques. The gamified format of the protocols allows for better patient engagement, thus allowing for more effective and efficient therapy. Participants will undergo a 2-hour training session, 2-3 days per week, over 12 weeks, for a total of 30 sessions. Hand function therapy will be administered in a specific and gamified manner to enhance rehabilitation of the hand and provide participants with greater opportunity to regain hand function over the course of the study.

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• Sustained a single stroke

Exclusion Criteria

• Severe spasticity or contractures (2 or less in the CMSA) or any other musculoskeletal or neuromuscular disorders that compromise sensation or other neuromuscular parameters will be excluded from the study. Prospective participants who are incapable of providing consent to participate in the research study will also be excluded (determined by an MMSE score of 23 or less).

• Minimum Eligible Age: 25 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Laurentian University, Health Science North

UNKNOWN

Sponsor Role: collaborator

IRegained Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Laurentian University

Greater Sudbury, Ontario, Canada

Site Status: RECRUITING

Countries

Canada

Central Contacts

Amy Doan, PhD Student

Role: CONTACT

adoan@laurentian.ca

705-675-1151 ext. 2351

Facility Contacts

Amy Doan, PhD

Role: primary

adoan@laurentian.ca

705-675-1151 ext. 2351

Other Identifiers

LUSUON0002

Identifier Type: -

Identifier Source: org_study_id