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

NCT05547217 | Unknown

• 1 other identifier: LUSUON0002
• Study Type: interventional
• Target: 8
• Locations: 1 country
• Sites: 1

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.

Conditions

Stroke; Engagement, Patient

Outcome Measures

Primary Outcomes (5)

• 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 Outcomes (3)

• 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

• 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

• 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

Study Arms (1)

Neurorehabilitation of the Hand

EXPERIMENTAL

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

Interventions

Hand Therapy using the MyHand System DEVICE

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.

Neurorehabilitation of the Hand

Eligibility Criteria

• Age: 25 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Sustained a single stroke

You may not qualify if:

• 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).

Sponsors & Collaborators

• IRegained Inc.: lead
• Laurentian University, Health Science North: collaborator

Study Sites (1)

Laurentian University

Greater Sudbury, Ontario, P3E 2C6, Canada

RECRUITING

MeSH Terms

Conditions

Stroke; Patient Participation

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Patient Acceptance of Health Care; Treatment Adherence and Compliance; Health Behavior; Behavior

Central Study Contacts

Amy Doan, PhD Student

CONTACT

705-675-1151; adoan@laurentian.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 14, 2022
• First Posted: September 21, 2022
• Study Start: September 19, 2022
• Primary Completion: September 19, 2023
• Study Completion: September 19, 2023
• Last Updated: April 3, 2023

Record last verified: 2023-03

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)