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

Stroke Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05547217
• Other study ID #: LUSUON0002
• Status: Recruiting
• Phase: N/A
• Start date: September 19, 2022
• Est. completion date: September 19, 2023

Study information

• Verified date: March 2023
• Source: IRegained Inc.
• Contact: Amy Doan, PhD Student
• Phone: 705-675-1151
• Email: adoan[@]laurentian.ca
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 8
• Est. completion date: September 19, 2023
• Est. primary completion date: September 19, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 25 Years to 85 Years

Eligibility

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).

Related Conditions & MeSH terms

• Brain Injuries
• Engagement, Patient
• Stroke

Intervention

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.

Locations

Country	Name	City	State
Canada	Laurentian University	Sudbury	Ontario

Sponsors (2)

Lead Sponsor	Collaborator
IRegained Inc.	Laurentian University, Health Science North

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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	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
Secondary	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
Secondary	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