Clinical trial NCT05547217: Gamification of Neurorehabilitation-centric Hand Exercises Post Stroke or Brain Injury
Official title: Gamification of Neurorehabilitation-centric Hand Exercises Post Stroke or Brain Injury
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Stroke
Engagement, Patient
Lead sponsor: IRegained Inc.
Sponsor class: INDUSTRY
Collaborators: name: Laurentian University, Health Science North
First posted: 2022-09-21
Enrollment: 8
Sex: ALL
Minimum age (years): 25
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


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).

Primary outcomes:
measure: the Chedoke Arm and Hand Activity Inventory -9 (CAHAI-9)- Change is being assessed
timeFrame: Baseline- before beginning the treatment, INTRA- after the completion of 15 treatment sessions and Post treatment- after the conclusion of 30 treatment sessions
measure: Box and Block Test- Change is being assessed
timeFrame: Baseline- before beginning the treatment, INTRA- after the completion of 15 treatment sessions and Post treatment- after the conclusion of 30 treatment sessions
measure: The Motor Activity Log- Change is being assessed
timeFrame: Baseline- before beginning the treatment, INTRA- after the completion of 15 treatment sessions and Post treatment- after the conclusion of 30 treatment sessions
measure: the NASA-Task Load Index (NASA-TLX)- Change is being assessed
timeFrame: After each treatment session
measure: European Quality of Life Five Dimension Questionnaire (EQ-5D)- Change is being assessed
timeFrame: Baseline- before beginning the treatment and Post treatment- after the conclusion of 30 treatment sessions
Secondary outcomes:
measure: Finger Goniometry- Change is being assessed
timeFrame: Baseline- before beginning the treatment, INTRA- after the completion of 15 treatment sessions and Post treatment- after the conclusion of 30 treatment sessions
measure: Grip Dynamometry- Change is being assessed
timeFrame: Baseline- before beginning the treatment, INTRA- after the completion of 15 treatment sessions and Post treatment- after the conclusion of 30 treatment sessions
measure: Pinch Dynamometry- Change is being assessed
timeFrame: Baseline- before beginning the treatment, INTRA- after the completion of 15 treatment sessions and Post treatment- after the conclusion of 30 treatment sessions
Other outcomes:
Locations:
city: Sudbury
country: Canada
facility: Laurentian University
state: Ontario
Study officials:
References: