An interventional study of Treatment using the MyHand System in Stroke and Hand Function, sponsored by IRegained Inc.. Status unknown at 1 site in Canada. Open to participants aged 18 Years to 100 Years. Per ClinicalTrials.gov, last updated 2023-04-13.
Sponsored by IRegained Inc. · Not applicable, Interventional, and Treatment
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.
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
IRegained Inc. is the lead sponsor of 4 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
-Sustained a single stroke >6months prior to start of study
Exclusion Criteria:
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.
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.
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.
Time frame: Baseline- before beginning the treatment and Post treatment- after the conclusion of 15 treatment sessions, within 5 days
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.
Time frame: Baseline- before beginning the treatment and Post treatment- after the conclusion of 15 treatment sessions, within 5 days
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.
Time frame: Baseline- before beginning the treatment and Post treatment- after the conclusion of 15 treatment sessions, within 5 days
Finger Goniometry- Change is being assessed
Estimate range of motion (ROM) of the various finger joints.
Time frame: Baseline- before beginning the treatment and Post treatment- after the conclusion of 15 treatment sessions, within 5 days
Grip Dynamometry- Change is being assessed
Measures participants grip strength
Time frame: Baseline- before beginning the treatment and Post treatment- after the conclusion of 15 treatment sessions, within 5 days
Pinch Dynamometry- Change is being assessed
Measures participants pinch strength
Time frame: Baseline- before beginning the treatment and Post treatment- after the conclusion of 15 treatment sessions, within 5 days
Plan to share: No
No publications or documents are linked to this record.
This study is status unknown, as verified in Mar 2023. You cannot join it, but the record below documents what was studied.
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IRegained Inc.