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

Primary Purpose

Stroke, Engagement, Patient

Status
Recruiting
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Hand Therapy using the MyHand System
Sponsored by
IRegained Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Stroke

Eligibility Criteria

25 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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).

Sites / Locations

  • Laurentian UniversityRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Neurorehabilitation of the Hand

Arm Description

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.

Outcomes

Primary Outcome Measures

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.
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.
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.
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.
European Quality of Life Five Dimension Questionnaire (EQ-5D)- Change is being assessed
To measure participants perceived quality of life through a questionnaire.

Secondary Outcome Measures

Finger Goniometry- Change is being assessed
estimate range of motion (ROM) of the various finger joints.
Grip Dynamometry- Change is being assessed
Measures participants grip strength
Pinch Dynamometry- Change is being assessed
Measures participants pinch strength

Full Information

First Posted
September 14, 2022
Last Updated
March 31, 2023
Sponsor
IRegained Inc.
Collaborators
Laurentian University, Health Science North
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1. Study Identification

Unique Protocol Identification Number
NCT05547217
Brief Title
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

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Recruiting
Study Start Date
September 19, 2022 (Actual)
Primary Completion Date
September 19, 2023 (Anticipated)
Study Completion Date
September 19, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
IRegained Inc.
Collaborators
Laurentian University, Health Science North

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke, Engagement, Patient

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
8 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Neurorehabilitation of the Hand
Arm Type
Experimental
Arm Description
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
Intervention Name(s)
Hand Therapy using the MyHand System
Intervention Description
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.
Primary Outcome Measure Information:
Title
the Chedoke Arm and Hand Activity Inventory -9 (CAHAI-9)- Change is being assessed
Description
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.
Time Frame
Baseline- before beginning the treatment, INTRA- after the completion of 15 treatment sessions and Post treatment- after the conclusion of 30 treatment sessions
Title
Box and Block Test- Change is being assessed
Description
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.
Time Frame
Baseline- before beginning the treatment, INTRA- after the completion of 15 treatment sessions and Post treatment- after the conclusion of 30 treatment sessions
Title
The Motor Activity Log- Change is being assessed
Description
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.
Time Frame
Baseline- before beginning the treatment, INTRA- after the completion of 15 treatment sessions and Post treatment- after the conclusion of 30 treatment sessions
Title
the NASA-Task Load Index (NASA-TLX)- Change is being assessed
Description
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.
Time Frame
After each treatment session
Title
European Quality of Life Five Dimension Questionnaire (EQ-5D)- Change is being assessed
Description
To measure participants perceived quality of life through a questionnaire.
Time Frame
Baseline- before beginning the treatment and Post treatment- after the conclusion of 30 treatment sessions
Secondary Outcome Measure Information:
Title
Finger Goniometry- Change is being assessed
Description
estimate range of motion (ROM) of the various finger joints.
Time Frame
Baseline- before beginning the treatment, INTRA- after the completion of 15 treatment sessions and Post treatment- after the conclusion of 30 treatment sessions
Title
Grip Dynamometry- Change is being assessed
Description
Measures participants grip strength
Time Frame
Baseline- before beginning the treatment, INTRA- after the completion of 15 treatment sessions and Post treatment- after the conclusion of 30 treatment sessions
Title
Pinch Dynamometry- Change is being assessed
Description
Measures participants pinch strength
Time Frame
Baseline- before beginning the treatment, INTRA- after the completion of 15 treatment sessions and Post treatment- after the conclusion of 30 treatment sessions

10. Eligibility

Sex
All
Minimum Age & Unit of Time
25 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
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).
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Amy Doan, PhD Student
Phone
705-675-1151
Ext
2351
Email
adoan@laurentian.ca
Facility Information:
Facility Name
Laurentian University
City
Sudbury
State/Province
Ontario
ZIP/Postal Code
P3E 2C6
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Amy Doan, PhD
Phone
705-675-1151
Ext
2351
Email
adoan@laurentian.ca
First Name & Middle Initial & Last Name & Degree
Amy Doan, PhD Student
First Name & Middle Initial & Last Name & Degree
Ratvinder Grewal, PhD
First Name & Middle Initial & Last Name & Degree
Vineet Johnson, PhD (c)
First Name & Middle Initial & Last Name & Degree
Mikayla Marshall, HBSc
First Name & Middle Initial & Last Name & Degree
Eric Dumais, HBSc

12. IPD Sharing Statement

Plan to Share IPD
No

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

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