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Completed

NCT Number: NCT05811806

Physiological Changes From Hand Movement Training

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.

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Key information

Conditions

Stroke Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Nervous System Diseases Vascular Diseases

Age range

18 year–100 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Baycrest Hospital

North York, Ontario, M6A 2E1, Canada

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Treatment using the MyHand System

Device

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.

Primary outcomes

  1. 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).

  2. 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.

  3. 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.

Secondary outcomes

  1. Finger Goniometry- Change is being assessed

    Time frame: 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.

  2. Grip Dynamometry- Change is being assessed

    Time frame: Baseline- before beginning the treatment and Post treatment- after the conclusion of 15 treatment sessions, within 5 days

    Measures participants grip strength

  3. Pinch Dynamometry- Change is being assessed

    Time frame: Baseline- before beginning the treatment and Post treatment- after the conclusion of 15 treatment sessions, within 5 days

    Measures participants pinch strength

Sponsors and collaborators

Lead sponsor

IRegained Inc.

Industry

Collaborators

  • Baycrest
  • McMaster University

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2022
Study completion
2022
First posted
Apr 13, 2023
Registry last updated
Apr 13, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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