Recruiting

IRegained

Sponsor:

IRegained Inc.

Code:

NCT05811819

Conditions

Stroke

Hand Function

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

Treatment using the MyHand System

Study Details

Brief summary:

10 participants with upper-limb impairment will be recruited from community sources. They will be invited to participate in a 15-day trial involving the IRegained device. The study will involve 2 assessment visits to McMaster, before and after the treatment, and 15 treatment visits. The data from the pilot study will be analyzed both quantitatively and qualitatively, as outcomes and explicit feedback from participants will be used to further optimize the device for future studies.

Conditions

Stroke

Hand Function

Study ID

NCT05811819

Start date

Oct 19, 2022

Status verified date

Mar, 2023

Completion date

Jul 9, 2023

Anticipated

Primary completion date

Jul 9, 2023

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Inclusion Criteria:

-Sustained a single stroke >6months prior to start of study

Exclusion Criteria:

  • Severe spasticity or contractures (2 or less in the CMSA)
  • any other musculoskeletal or neuromuscular disorders that compromise sensation
  • 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

10 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Neurorehabilitation of the Hand

Participants will undergo a 1-hour training session 5 days per week, over 3 weeks for a total of 15 sessions. Hand function therapy will be administered using the gamified protocol to enhance rehabilitation of the hand and provide participants with greater opportunity to regain hand function over the course of the study.

Interventions

Treatment using the MyHand System

Participants will undergo three weeks of 1-hour hand therapy with the MyHand System. The MyHand System 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.

Primary outcome measure

  • Chedoke Arm and Hand Activity Inventory 9 (CAHAI-9)- Change is being assessed [ Time Frame: Baseline- before beginning the treatment and Post treatment- after the conclusion of 15 treatment sessions, within 5 days ]
  • ABILHAND- Change is being assessed [ Time Frame: Baseline- before beginning the treatment and Post treatment- after the conclusion of 15 treatment sessions, within 5 days ]
  • Box and Block (BBT)- Change is being assessed [ Time Frame: Baseline- before beginning the treatment and Post treatment- after the conclusion of 15 treatment sessions, within 5 days ]

Central Contacts and Locations

Central contacts

Ravjot Rehsi, MSc

9052996418rehsir@mcmaster.ca

Mikayla Marshall

2898088821mikayla@iregained.ca

Locations

Aimee Nelson

Recruiting

Hamilton, Ontario, Canada, L8L 8E7

Contacts

Mikayla Marshall

2898088821mikayla@iregained.ca

More Information

Sponsor

IRegained Inc.

Last update posted

Apr 13, 2023

Last verified

Mar, 2023

Keywords

  • Hand Function
  • Rehabilitation
  • stroke rehabilitation
  • Motor control
  • Hand Rehabilitation
  • Neurorehabilitation

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 2023-04-13.