Physiological Changes From Hand Movement Training

Stroke Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05811806
• Other study ID #: BHMU0001
• Status: Completed
• Phase: N/A
• Start date: May 2, 2022
• Est. completion date: August 4, 2022

Study information

• Verified date: March 2023
• Source: IRegained Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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: Completed
• Enrollment: 11
• Est. completion date: August 4, 2022
• Est. primary completion date: August 4, 2022
• 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 24 or less).
• Botox Injections less than 2 months prior to starting the study

Related Conditions & MeSH terms

• 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	Baycrest Hospital	North York	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	Action Research Arm Test (ARAT)- Change is being assessed	ARAT is a 19 item observational measure used to assess upper extremity performance (coordination, dexterity and functioning) in stroke recovery, brain injury and multiple sclerosis populations. Items comprising the ARAT are categorized into four subscales (grasp, grip, pinch and gross movement) and arranged in order of decreasing difficulty, with the most difficult task examined first, followed by the least difficult task. Task performance is rated on a 4-point scale, ranging from 0 (no movement) to 3 (movement performed normally).	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- after the completion of 15 treatment sessions, within 5 days
Primary	Box and Block Test (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