Physiological Changes From Hand Movement Training

IRegained

Status: Completed

Conditions: Stroke

Treatments: Device: Treatment using the MyHand System

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT05811806

BHMU0001

Details and patient eligibility

About

11 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 Baycrest, 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.

Full 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

Enrollment: 11 patients

Sex: All

Ages: 18 to 100 years old

Volunteers: No 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 24 or less).
• Botox Injections less than 2 months prior to starting the study

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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11 participants in 1 patient group

Neurorehabilitation of the Hand

Experimental group

Description:

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.

Treatment:

Device: Treatment using the MyHand System