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Hand Training & Brain Changes

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

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05811819
Enrollment
10
Registered
2023-04-13
Start date
2022-10-19
Completion date
2023-07-09
Last updated
2023-04-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hand Function, Stroke

Keywords

Hand Function, Rehabilitation, stroke rehabilitation, Motor control, Hand Rehabilitation, Neurorehabilitation

Brief 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.

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

Interventions

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.

Sponsors

Baycrest
CollaboratorOTHER
McMaster University
CollaboratorOTHER
IRegained Inc.
Lead SponsorINDUSTRY

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 100 Years
Healthy volunteers
No

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).

Design outcomes

Primary

MeasureTime frameDescription
Chedoke Arm and Hand Activity Inventory 9 (CAHAI-9)- Change is being assessedBaseline- before beginning the treatment and Post treatment- after the conclusion of 15 treatment sessions, within 5 daysa 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.
ABILHAND- Change is being assessedBaseline- before beginning the treatment and Post treatment- after the conclusion of 15 treatment sessions, within 5 daysa 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.
Box and Block (BBT)- Change is being assessedBaseline- before beginning the treatment and Post treatment- after the conclusion of 15 treatment sessions, within 5 daysThe 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.

Secondary

MeasureTime frameDescription
Finger Goniometry- Change is being assessedBaseline- before beginning the treatment and Post treatment- after the conclusion of 15 treatment sessions, within 5 daysEstimate range of motion (ROM) of the various finger joints.
Grip Dynamometry- Change is being assessedBaseline- before beginning the treatment and Post treatment- after the conclusion of 15 treatment sessions, within 5 daysMeasures participants grip strength
Pinch Dynamometry- Change is being assessedBaseline- before beginning the treatment and Post treatment- after the conclusion of 15 treatment sessions, within 5 daysMeasures participants pinch strength

Countries

Canada

Contacts

Primary ContactRavjot Rehsi, MSc
rehsir@mcmaster.ca9052996418
Backup ContactMikayla Marshall
mikayla@iregained.ca2898088821

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026