Hand Training & Brain Changes
- Conditions
- StrokeHand Function
- Interventions
- Device: Treatment using the MyHand System
- Registration Number
- NCT05811819
- Lead Sponsor
- IRegained Inc.
- 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
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 10
-Sustained a single stroke >6months prior to start of study
- 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).
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Neurorehabilitation of the Hand Treatment using the MyHand System 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.
- Primary Outcome Measures
Name Time Method ABILHAND- Change is being assessed Baseline- before beginning the treatment and Post treatment- after the conclusion of 15 treatment sessions, within 5 days 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.
Chedoke Arm and Hand Activity Inventory 9 (CAHAI-9)- Change is being assessed Baseline- before beginning the treatment and Post treatment- after the conclusion of 15 treatment sessions, within 5 days 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.
Box and Block (BBT)- Change is being assessed Baseline- before beginning the treatment and Post treatment- after the conclusion of 15 treatment sessions, within 5 days 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.
- Secondary Outcome Measures
Name Time Method Grip Dynamometry- Change is being assessed Baseline- before beginning the treatment and Post treatment- after the conclusion of 15 treatment sessions, within 5 days Measures participants grip strength
Finger Goniometry- Change is being assessed Baseline- before beginning the treatment and Post treatment- after the conclusion of 15 treatment sessions, within 5 days Estimate range of motion (ROM) of the various finger joints.
Pinch Dynamometry- Change is being assessed Baseline- before beginning the treatment and Post treatment- after the conclusion of 15 treatment sessions, within 5 days Measures participants pinch strength
Trial Locations
- Locations (1)
Aimee Nelson
🇨🇦Hamilton, Ontario, Canada