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

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.

Study Overview

• Status: Recruiting
• Conditions: Stroke; Engagement, Patient
• Intervention / Treatment: Device: Hand Therapy using the MyHand System

• Study Type: Interventional
• Enrollment (Anticipated): 8
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Amy Doan, PhD Student; Phone Number: 2351 705-675-1151; Email: adoan@laurentian.ca

Study Locations

• Canada
  • Ontario
    • Sudbury, Ontario, Canada, P3E 2C6
      • Recruiting
      • Laurentian University
      • Contact: Amy Doan, PhD; Phone Number: 2351 705-675-1151; Email: adoan@laurentian.ca
      • Principal Investigator: Amy Doan, PhD Student
      • Principal Investigator: Ratvinder Grewal, PhD
      • Sub-Investigator: Vineet Johnson, PhD (c)
      • Sub-Investigator: Mikayla Marshall, HBSc
      • Sub-Investigator: Eric Dumais, HBSc

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 25 years to 85 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: 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.

Device: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
the Chedoke Arm and Hand Activity Inventory -9 (CAHAI-9)- Change is being assessed	a 9-item assessment, will be performed by a trained clinician to estimate a participants functional ability during the initial assessment. The CAHAI-9 requires a participant to perform 9 bimanual ADLs, each of which will be scored on a 7 point scale.	Baseline- before beginning the treatment, INTRA- after the completion of 15 treatment sessions and Post treatment- after the conclusion of 30 treatment sessions
Box and Block Test- Change is being assessed	The BBT requires participants to move cubical wooden blocks over a partition from one box to another. Grip and pinch dynamometry will be used to assess a participant's hand strength.	Baseline- before beginning the treatment, INTRA- after the completion of 15 treatment sessions and Post treatment- after the conclusion of 30 treatment sessions
The Motor Activity Log- Change is being assessed	Estimates how much and how well a participant is able to use their affected upper limb. The MAL is a 30 item questionnaire administered in through a semi-structured interview between the participant and a trained clinician.	Baseline- before beginning the treatment, INTRA- after the completion of 15 treatment sessions and Post treatment- after the conclusion of 30 treatment sessions
the NASA-Task Load Index (NASA-TLX)- Change is being assessed	an assessment tool used to evaluate a participants perceived cognitive load during a session. The NASA-TLX has six sub-scales; mental demand, temporal demand, frustration, performance, effort and physical demand. The NASA-TLX scores, time taken to complete a level, game score and verbal language references made during gameplay will be used to estimate engagement.	After each treatment session
European Quality of Life Five Dimension Questionnaire (EQ-5D)- Change is being assessed	To measure participants perceived quality of life through a questionnaire.	Baseline- before beginning the treatment and Post treatment- after the conclusion of 30 treatment sessions

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Finger Goniometry- Change is being assessed	estimate range of motion (ROM) of the various finger joints.	Baseline- before beginning the treatment, INTRA- after the completion of 15 treatment sessions and Post treatment- after the conclusion of 30 treatment sessions
Grip Dynamometry- Change is being assessed	Measures participants grip strength	Baseline- before beginning the treatment, INTRA- after the completion of 15 treatment sessions and Post treatment- after the conclusion of 30 treatment sessions
Pinch Dynamometry- Change is being assessed	Measures participants pinch strength	Baseline- before beginning the treatment, INTRA- after the completion of 15 treatment sessions and Post treatment- after the conclusion of 30 treatment sessions

Collaborators and Investigators

• Sponsor: IRegained Inc.
• Collaborators: Laurentian University, Health Science North

Study record dates

Study Major Dates

• Study Start (Actual): September 19, 2022
• Primary Completion (Anticipated): September 19, 2023
• Study Completion (Anticipated): September 19, 2023

Study Registration Dates

• First Submitted: September 14, 2022
• First Submitted That Met QC Criteria: September 19, 2022
• First Posted (Actual): September 21, 2022

Study Record Updates

• Last Update Posted (Actual): April 3, 2023
• Last Update Submitted That Met QC Criteria: March 31, 2023
• Last Verified: March 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Wounds and Injuries; Craniocerebral Trauma; Trauma, Nervous System; Stroke; Brain Injuries
• Other Study ID Numbers: LUSUON0002

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No