Hand Training & Brain Changes

Stroke Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05811819
• Other study ID #: BHMU0002
• Status: Recruiting
• Phase: N/A
• Start date: October 19, 2022
• Est. completion date: July 9, 2023

Study information

• Verified date: March 2023
• Source: IRegained Inc.
• Contact: Ravjot Rehsi, MSc
• Phone: 9052996418
• Email: rehsir[@]mcmaster.ca
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 10
• Est. completion date: July 9, 2023
• Est. primary completion date: July 9, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 100 Years

Eligibility

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).

Related Conditions & MeSH terms

• Hand Function
• Stroke

Intervention

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.

Locations

Country	Name	City	State
Canada	Aimee Nelson	Hamilton	Ontario

Sponsors (3)

Lead Sponsor	Collaborator
IRegained Inc.	Baycrest, McMaster University

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Chedoke Arm and Hand Activity Inventory 9 (CAHAI-9)- Change is being assessed	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.	Baseline- before beginning the treatment and Post treatment- after the conclusion of 15 treatment sessions, within 5 days
Primary	ABILHAND- Change is being assessed	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.	Baseline- before beginning the treatment and Post treatment- after the conclusion of 15 treatment sessions, within 5 days
Primary	Box and Block (BBT)- Change is being assessed	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.	Baseline- before beginning the treatment and Post treatment- after the conclusion of 15 treatment sessions, within 5 days
Secondary	Finger Goniometry- Change is being assessed	Estimate range of motion (ROM) of the various finger joints.	Baseline- before beginning the treatment and Post treatment- after the conclusion of 15 treatment sessions, within 5 days
Secondary	Grip Dynamometry- Change is being assessed	Measures participants grip strength	Baseline- before beginning the treatment and Post treatment- after the conclusion of 15 treatment sessions, within 5 days
Secondary	Pinch Dynamometry- Change is being assessed	Measures participants pinch strength	Baseline- before beginning the treatment and Post treatment- after the conclusion of 15 treatment sessions, within 5 days