Hand Training & Brain Changes

NCT ID: NCT05811819

Last Updated: 2023-04-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

10 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-10-19

Study Completion Date

2023-07-09

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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

See the medical conditions and disease areas that this research is targeting or investigating.

Stroke Hand Function

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are 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).
Minimum Eligible Age

18 Years

Maximum Eligible Age

100 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Baycrest

OTHER

Sponsor Role collaborator

McMaster University

OTHER

Sponsor Role collaborator

IRegained Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Aimee Nelson, PhD

Role: PRINCIPAL_INVESTIGATOR

McMaster University

Jed Meltzer, PhD

Role: STUDY_DIRECTOR

Baycrest Hospital

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Aimee Nelson

Hamilton, Ontario, Canada

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

Canada

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Ravjot Rehsi, MSc

Role: CONTACT

9052996418

Mikayla Marshall

Role: CONTACT

2898088821

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Mikayla Marshall

Role: primary

2898088821

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

BHMU0002

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Hand Rehabilitation Study for Stroke Patients
NCT03148106 ACTIVE_NOT_RECRUITING NA