Hand Training & Brain Changes

Sponsor

IRegained Inc. (Industry)

Overall Status

Recruiting

CT.gov ID

NCT05811819

Collaborator

Baycrest (Other), McMaster University (Other)

Enrollment

Location

Arm

8.6

Anticipated Duration (Months)

1.2

Patients Per Site Per Month

Study Details

Study Description

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.

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

Detailed Description

This pilot study will investigate the potential changes in the brain area controlling hand movement following 15 days of exercises to improve hand function in participants with upper limb impairments resulting from stroke. A device developed by Dr. Vineet Johnson (IRegained Inc.) will be used to administer standardized exercises to improve hand function. To assess brain changes, transcranial magnetic stimulation pulses will be delivered to the motor cortex. The motor evoked potential (MEP), a muscle response evoked from the TMS, will be measured using electrodes on the hand. This study will test the feasibility of conducting motor therapy using this device while assessing potential changes in motor cortex function. Findings from this study will contribute to developing treatment trials aimed at improving impaired limb function in stroke patients and quality of life in these individuals

Study Design

Study Type:

Interventional

Anticipated Enrollment :

10 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

Reversing Physiological Dysfunction With Non-invasive Brain Stimulation: Physiological Changes From Hand Movement Therapy

Actual Study Start Date :

Oct 19, 2022

Anticipated Primary Completion Date :

Jul 9, 2023

Anticipated Study Completion Date :

Jul 9, 2023

Arms and Interventions

Arm	Intervention/Treatment
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.	Device: 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.

Arm

Intervention/Treatment

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.

Device: 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.

Outcome Measures

Primary Outcome Measures

Chedoke Arm and Hand Activity Inventory 9 (CAHAI-9)- Change is being assessed [Baseline- before beginning the treatment and Post treatment- after the conclusion of 15 treatment sessions, within 5 days]
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.
ABILHAND- Change is being assessed [Baseline- before beginning the treatment and Post treatment- after the conclusion of 15 treatment sessions, within 5 days]
a subjective functional assessment tool will be used. The tool is a 23-item survey, and participants are provided with a list of various everyday functional tasks and are scored based on patient response. For example, participant will be asked whether it is 'easy', 'difficult' or 'impossible' for each of the 23 tasks.
Box and Block (BBT)- Change is being assessed [Baseline- before beginning the treatment and Post treatment- after the conclusion of 15 treatment sessions, within 5 days]
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.

Secondary Outcome Measures

Finger Goniometry- Change is being assessed [Baseline- before beginning the treatment and Post treatment- after the conclusion of 15 treatment sessions, within 5 days]
Estimate range of motion (ROM) of the various finger joints.
Grip Dynamometry- Change is being assessed [Baseline- before beginning the treatment and Post treatment- after the conclusion of 15 treatment sessions, within 5 days]
Measures participants grip strength
Pinch Dynamometry- Change is being assessed [Baseline- before beginning the treatment and Post treatment- after the conclusion of 15 treatment sessions, within 5 days]
Measures participants pinch strength

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 100 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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).