Recruiting

Neurorehabilitation

Sponsor:

IRegained Inc.

Code:

NCT05547217

Conditions

Stroke

Engagement, Patient

Eligibility Criteria

Sex: All

Age: 25 - 70+

Healthy Volunteers: Not accepted

Interventions

Hand Therapy using the MyHand System

Study Details

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

Study ID

NCT05547217

Start date

Sep 19, 2022

Status verified date

Mar, 2023

Completion date

Sep 19, 2023

Anticipated

Primary completion date

Sep 19, 2023

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 25 - 70+

Healthy Volunteers: Not accepted

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).

Study Design

Enrollment

8 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

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.

Interventions

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.

Primary outcome measure

  • the Chedoke Arm and Hand Activity Inventory -9 (CAHAI-9)- Change is being assessed [ 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 ]
  • Box and Block Test- Change is being assessed [ 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 ]
  • The Motor Activity Log- Change is being assessed [ 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 ]
  • the NASA-Task Load Index (NASA-TLX)- Change is being assessed [ Time Frame: After each treatment session ]
  • European Quality of Life Five Dimension Questionnaire (EQ-5D)- Change is being assessed [ Time Frame: Baseline- before beginning the treatment and Post treatment- after the conclusion of 30 treatment sessions ]

Central Contacts and Locations

Central contacts

Locations

Laurentian University

Recruiting

Sudbury, Ontario, Canada, P3E 2C6

Contacts

Principal Investigator:

Amy Doan, PhD Student

More Information

Sponsor

IRegained Inc.

Last update posted

Apr 3, 2023

Last verified

Mar, 2023

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by IRegained Inc. on 2023-04-03.