NCT05811819|Unknown
Hand Training & Brain Changes
Reversing Physiological Dysfunction With Non-invasive Brain Stimulation: Physiological Changes From Hand Movement Therapy
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Reversing Physiological Dysfunction With Non-invasive Brain Stimulation: Physiological Changes From Hand Movement Therapy
Sponsor study identifier
interventional
10
1 country
1
Study Start
October 19, 2022
Actual (reported)Primary Completion
July 9, 2023
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
July 9, 2023
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
July 9, 2023
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
September 28, 2022
Actual (reported)October 19, 2022
Actual (reported)April 13, 2023
Actual (reported)July 9, 2023
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
July 9, 2023
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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
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
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
Finger Goniometry- Change is being assessed
Baseline- before beginning the treatment and Post treatment- after the conclusion of 15 treatment sessions, within 5 days
Grip Dynamometry- Change is being assessed
Baseline- before beginning the treatment and Post treatment- after the conclusion of 15 treatment sessions, within 5 days
Pinch Dynamometry- Change is being assessed
Baseline- before beginning the treatment and Post treatment- after the conclusion of 15 treatment sessions, within 5 days
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.
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.
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Aimee Nelson
Hamilton, Ontario, L8L 8E7, Canada
Aimee Nelson, PhD
McMaster University
Jed Meltzer, PhD
Baycrest Hospital
First Submitted
September 28, 2022
First Posted
April 13, 2023
Study Start
October 19, 2022
Actual (reported)Primary Completion
July 9, 2023
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Gamification of Neurorehabilitation-centric Hand Exercises Post Stroke or Brain Injury
Contact the study team to confirm eligibility.
Study Completion
July 9, 2023
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Last Updated
April 13, 2023
Record last verified: 2023-03
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Source: ClinicalTrials.gov.
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