Physiological Changes From Hand Movement Training

NCT ID: NCT05811806

Last Updated: 2023-04-13

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 11 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-05-02
• Study Completion Date: 2022-08-04

Brief Summary

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.

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

Conditions

Stroke

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Treatment using the MyHand System

Intervention Type: DEVICE

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.

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.

Intervention Type: DEVICE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 100 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Baycrest

OTHER

Sponsor Role: collaborator

McMaster University

OTHER

Sponsor Role: collaborator

IRegained Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jed Meltzer, PhD

Role: PRINCIPAL_INVESTIGATOR

Baycrest Hospital

Locations

Baycrest Hospital

North York, Ontario, Canada

Countries

Canada

Other Identifiers

BHMU0001

Identifier Type: -

Identifier Source: org_study_id