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Hand Training & Brain Changes

Primary Purpose

Stroke, Hand Function

Status
Recruiting
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Treatment using the MyHand System
Sponsored by
IRegained Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Stroke focused on measuring Hand Function, Rehabilitation, stroke rehabilitation, Motor control, Hand Rehabilitation, Neurorehabilitation

Eligibility Criteria

18 Years - 100 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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 23 or less).

Sites / Locations

  • Aimee NelsonRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Neurorehabilitation of the Hand

Arm Description

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.

Outcomes

Primary Outcome Measures

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.
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.
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.

Secondary Outcome Measures

Finger Goniometry- Change is being assessed
Estimate range of motion (ROM) of the various finger joints.
Grip Dynamometry- Change is being assessed
Measures participants grip strength
Pinch Dynamometry- Change is being assessed
Measures participants pinch strength

Full Information

First Posted
September 28, 2022
Last Updated
March 31, 2023
Sponsor
IRegained Inc.
Collaborators
Baycrest, McMaster University
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1. Study Identification

Unique Protocol Identification Number
NCT05811819
Brief Title
Hand Training & Brain Changes
Official Title
Reversing Physiological Dysfunction With Non-invasive Brain Stimulation: Physiological Changes From Hand Movement Therapy
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Recruiting
Study Start Date
October 19, 2022 (Actual)
Primary Completion Date
July 9, 2023 (Anticipated)
Study Completion Date
July 9, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
IRegained Inc.
Collaborators
Baycrest, McMaster University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke, Hand Function
Keywords
Hand Function, Rehabilitation, stroke rehabilitation, Motor control, Hand Rehabilitation, Neurorehabilitation

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
10 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Neurorehabilitation of the Hand
Arm Type
Experimental
Arm Description
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 Type
Device
Intervention Name(s)
Treatment using the MyHand System
Intervention Description
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 Outcome Measure Information:
Title
Chedoke Arm and Hand Activity Inventory 9 (CAHAI-9)- Change is being assessed
Description
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
Title
ABILHAND- Change is being assessed
Description
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
Title
Box and Block (BBT)- Change is being assessed
Description
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
Secondary Outcome Measure Information:
Title
Finger Goniometry- Change is being assessed
Description
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
Title
Grip Dynamometry- Change is being assessed
Description
Measures participants grip strength
Time Frame
Baseline- before beginning the treatment and Post treatment- after the conclusion of 15 treatment sessions, within 5 days
Title
Pinch Dynamometry- Change is being assessed
Description
Measures participants pinch strength
Time Frame
Baseline- before beginning the treatment and Post treatment- after the conclusion of 15 treatment sessions, within 5 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
100 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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 23 or less).
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ravjot Rehsi, MSc
Phone
9052996418
Email
rehsir@mcmaster.ca
First Name & Middle Initial & Last Name or Official Title & Degree
Mikayla Marshall
Phone
2898088821
Email
mikayla@iregained.ca
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Aimee Nelson, PhD
Organizational Affiliation
McMaster University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Jed Meltzer, PhD
Organizational Affiliation
Baycrest Hospital
Official's Role
Study Director
Facility Information:
Facility Name
Aimee Nelson
City
Hamilton
State/Province
Ontario
ZIP/Postal Code
L8L 8E7
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mikayla Marshall
Phone
2898088821
Email
mikayla@iregained.ca

12. IPD Sharing Statement

Plan to Share IPD
No

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Hand Training & Brain Changes

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