Reversing Physiological Dysfunction With Non-invasive Brain Stimulation: Physiological Changes From Hand Movement Therapy
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- IRegained Inc.
- Enrollment
- 11
- Locations
- 1
- Primary Endpoint
- Box and Block Test (BBT)- Change is being assessed
Study Overview
Brief 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.
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
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 100 Years (Adult, Older Adult)
- Sex
- All
- Accepts 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 24 or less).
- •Botox Injections less than 2 months prior to starting the study
Arms & Interventions
Neurorehabilitation of the Hand
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.
Intervention: Treatment using the MyHand System (Device)
Outcomes
Primary Outcomes
Box and Block Test (BBT)- Change is being assessed
Time Frame: 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.
Action Research Arm Test (ARAT)- Change is being assessed
Time Frame: Baseline- before beginning the treatment and Post treatment- after the conclusion of 15 treatment sessions, within 5 days
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).
ABILHAND- Change is being assessed
Time Frame: Baseline- before beginning the treatment, and Post- after the completion 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.
Secondary Outcomes
- 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)