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

Sponsor
IRegained Inc. (Industry)
Overall Status
Recruiting
CT.gov ID
NCT05547217
Collaborator
Laurentian University, Health Science North (Other)
8
1
1
3
2.7

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Device: Hand Therapy using the MyHand System
N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
8 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Gamification of Neurorehabilitation-centric Hand Exercises Post Stroke or Brain Injury
Actual Study Start Date :
Sep 19, 2022
Anticipated Primary Completion Date :
Dec 19, 2022
Anticipated Study Completion Date :
Dec 19, 2022

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

  1. the Chedoke Arm and Hand Activity Inventory -9 (CAHAI-9)- Change is being assessed [Baseline- before beginning the treatment, INTRA- after the completion of 15 treatment sessions and Post treatment- after the conclusion of 30 treatment sessions]

    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.

  2. Box and Block Test- Change is being assessed [Baseline- before beginning the treatment, INTRA- after the completion of 15 treatment sessions and Post treatment- after the conclusion of 30 treatment sessions]

    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.

  3. The Motor Activity Log- Change is being assessed [Baseline- before beginning the treatment, INTRA- after the completion of 15 treatment sessions and Post treatment- after the conclusion of 30 treatment sessions]

    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.

  4. the NASA-Task Load Index (NASA-TLX)- Change is being assessed [After each treatment session]

    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.

  5. European Quality of Life Five Dimension Questionnaire (EQ-5D)- Change is being assessed [Baseline- before beginning the treatment and Post treatment- after the conclusion of 30 treatment sessions]

    To measure participants perceived quality of life through a questionnaire.

Secondary Outcome Measures

  1. Finger Goniometry- Change is being assessed [Baseline- before beginning the treatment, INTRA- after the completion of 15 treatment sessions and Post treatment- after the conclusion of 30 treatment sessions]

    estimate range of motion (ROM) of the various finger joints.

  2. Grip Dynamometry- Change is being assessed [Baseline- before beginning the treatment, INTRA- after the completion of 15 treatment sessions and Post treatment- after the conclusion of 30 treatment sessions]

    Measures participants grip strength

  3. Pinch Dynamometry- Change is being assessed [Baseline- before beginning the treatment, INTRA- after the completion of 15 treatment sessions and Post treatment- after the conclusion of 30 treatment sessions]

    Measures participants pinch strength

Eligibility Criteria

Criteria

Ages Eligible for Study:
25 Years to 85 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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).

Contacts and Locations

Locations

Site City State Country Postal Code
1 Laurentian University Sudbury Ontario Canada P3E 2C6

Sponsors and Collaborators

  • IRegained Inc.
  • Laurentian University, Health Science North

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
IRegained Inc.
ClinicalTrials.gov Identifier:
NCT05547217
Other Study ID Numbers:
  • LUSUON0002
First Posted:
Sep 21, 2022
Last Update Posted:
Sep 23, 2022
Last Verified:
Sep 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Sep 23, 2022