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

Study Overview
=================
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.

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

Conditions
-----------------
Stroke, Engagement, Patient

Intervention / Treatment
-----------------
* Device: Hand Therapy using the MyHand System


Participation Criteria
=================
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).

Ages Eligible for Study
-----------------
Minimum Age: 25 Years
Maximum Age: 85 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Neurorehabilitation of the Hand<br>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<br>* 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.<br>|

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 |