StrokeNCT05547217
Gamification of Neurorehabilitation-centric Hand Exercises Post Stroke or Brain Injury
A study testing Hand Therapy using the MyHand System in people with Stroke and Engagement, Patient, run by IRegained Inc. at 1 site in Canada.
Trial summary
Stroke is the leading cause of adult disability worldwide. Often, severe neurological deficits occur after a stroke and roughly 70% of all stroke survivors have some form of hand function disability. To improve the lives of those with hand function disability, IRegained Inc. has created the MyHandTM System. Read more about this study
- Who is it for?
- Ages 25 to 85 years
- Conditions the study is for
- Stroke, Engagement, Patient
- What is being tested?
- Hand Therapy using the MyHand System
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 8 participants
- Where
- 1 siteCanada
- Study dates
- 19 Sep 2022to 19 Sep 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 25 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Sustained a single stroke
Who cannot join
- Severe spasticity or contractures (2 or less in the CMSA) or any other musculoskeletal or neuromuscular disorders that compromise sensation or other neuromuscular parameters will be excluded from the study. 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).
Trial locations and contacts
1 site in 1 country.
Canada1 site, 1 recruiting
- Recruiting
Laurentian University
Greater Sudbury, Ontario, P3E 2C6
Amy Doan, PhD, 705-675-1151 ext. 2351, adoan@laurentian.ca
Amy Doan, PhD Student
About this study
Stroke is the leading cause of adult disability worldwide. Often, severe neurological deficits occur after a stroke and roughly 70% of all stroke survivors have some form of hand function disability. To improve the lives of those with hand function disability, IRegained Inc. has created the MyHandTM System. The MyHandTM System is a smart-mechatronic device programmed with proprietary hand function training regiments (protocols) based on deep research in neuroplasticity. It 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. Individuals who have sustained a stroke 5 months or earlier (considered to be chronic stroke survivors) will be eligible to participate in this study. Participants will undergo a 2-hour training session, 2-3 days per week, over 12 weeks, for a total of 30 sessions. Hand function therapy will be administered in a specific and gamified manner to enhance rehabilitation of the hand and provide participants with greater opportunity to regain hand function over the course of the study. The goal of this research project is to understand how a gamified approach to hand function rehabilitation impacts engagement and motivation. This understanding will directly translate into the development of more efficient and effective modes of therapy.
- Conditions
- Stroke, Engagement, Patient
- Being tested
- Hand Therapy using the MyHand System
- Medical subject headings
- Stroke, Patient Participation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hand Therapy using the MyHand SystemDevice
The MyHandTM System is a smart-mechatronic device programmed with proprietary hand function training regiments (protocols) based on deep research in neuroplasticity. It 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. Participants will undergo a 2-hour training session, 2-3 days per week, over 12 weeks, for a total of 30 sessions. Hand function therapy will be administered in a specific and gamified manner to enhance rehabilitation of the hand and provide participants with greater opportunity to regain hand function over the course of the study.
| Study group | Role | What they receive |
|---|---|---|
| Neurorehabilitation of the Hand | Experimental | Participants will undergo a 2-hour training session, 2-3 days per week, over 12 weeks, for a total of 30 sessions. Hand function therapy will be administered in a specific and gamified manner to enhance rehabilitation of the hand and provide participants with greater opportunity to regain hand function over the course of the study. Receives: Device: Hand Therapy using the MyHand System |
What is being measured
The primary outcome is the main question the study is designed to answer.
the 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.
Measured: Baseline- before beginning the treatment, INTRA- after the completion of 15 treatment sessions and Post treatment- after the conclusion of 30 treatment sessions
Box and Block Test- 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.
Measured: Baseline- before beginning the treatment, INTRA- after the completion of 15 treatment sessions and Post treatment- after the conclusion of 30 treatment sessions
The Motor Activity Log- Change is being assessed
Estimates how much and how well a participant is able to use their affected upper limb. The MAL is a 30 item questionnaire administered in through a semi-structured interview between the participant and a trained clinician.
Measured: Baseline- before beginning the treatment, INTRA- after the completion of 15 treatment sessions and Post treatment- after the conclusion of 30 treatment sessions
the NASA-Task Load Index (NASA-TLX)- Change is being assessed
an assessment tool used to evaluate a participants perceived cognitive load during a session. The NASA-TLX has six sub-scales; mental demand, temporal demand, frustration, performance, effort and physical demand. The NASA-TLX scores, time taken to complete a level, game score and verbal language references made during gameplay will be used to estimate engagement.
Measured: After each treatment session
European Quality of Life Five Dimension Questionnaire (EQ-5D)- Change is being assessed
To measure participants perceived quality of life through a questionnaire.
Measured: Baseline- before beginning the treatment and Post treatment- after the conclusion of 30 treatment sessions
Secondary outcomes (3)
Finger Goniometry- Change is being assessed
estimate range of motion (ROM) of the various finger joints.
Measured: Baseline- before beginning the treatment, INTRA- after the completion of 15 treatment sessions and Post treatment- after the conclusion of 30 treatment sessions
Grip Dynamometry- Change is being assessed
Measures participants grip strength
Measured: Baseline- before beginning the treatment, INTRA- after the completion of 15 treatment sessions and Post treatment- after the conclusion of 30 treatment sessions
Pinch Dynamometry- Change is being assessed
Measures participants pinch strength
Measured: Baseline- before beginning the treatment, INTRA- after the completion of 15 treatment sessions and Post treatment- after the conclusion of 30 treatment sessions
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2022
- Study start19 Sep 2022
- Primary completion19 Sep 2023 (estimated)
- Study completion19 Sep 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for StrokeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 8 participants (estimated)
Sponsor and investigators
- Lead sponsor
- IRegained Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Laurentian University, Health Science North
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05547217
- Sponsor's protocol ID
- LUSUON0002
- Status last verified
- Mar 2023
- First submitted
- 14 Sep 2022
- Last updated
- 3 Apr 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Gamification of Neurorehabilitation-centric Hand Exercises Post Stroke or Brain Injury
- ClinicalTrials.gov ID
- NCT05547217
- Acronym / sponsor ID
- LUSUON0002
- Conditions
- Stroke, Engagement, Patient
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 8 participants (estimated)
- Lead sponsor
- IRegained Inc.Industry (pharma, biotech, devices)
- Collaborators
- Laurentian University, Health Science North
- Study start
- 19 Sep 2022 (actual)
- Primary completion
- 19 Sep 2023 (estimated)
- Study completion
- 19 Sep 2023 (estimated)
- First posted
- 21 Sep 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Stroke is the leading cause of adult disability worldwide. Often, severe neurological deficits occur after a stroke and roughly 70% of all stroke survivors have some form of hand function disability. To improve the lives of those with hand function disability, IRegained Inc. has created the MyHandTM System. The MyHandTM System is a smart-mechatronic device programmed with proprietary hand function training regiments (protocols) based on deep research in neuroplasticity. It 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. Individuals who have sustained a stroke 5 months or earlier (considered to be chronic stroke survivors) will be eligible to participate in this study. Participants will undergo a 2-hour training session, 2-3 days per week, over 12 weeks, for a total of 30 sessions. Hand function therapy will be administered in a specific and gamified manner to enhance rehabilitation of the hand and provide participants with greater opportunity to regain hand function over the course of the study. The goal of this research project is to understand how a gamified approach to hand function rehabilitation impacts engagement and motivation. This understanding will directly translate into the development of more efficient and effective modes of therapy.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Neurorehabilitation of the Hand | Experimental | Device: Hand Therapy using the MyHand SystemParticipants will undergo a 2-hour training session, 2-3 days per week, over 12 weeks, for a total of 30 sessions. Hand function therapy will be administered in a specific and gamified manner to enhance rehabilitation of the hand and provide participants with greater opportunity to regain hand function over the course of the study. |
Who may qualify
- Ages
- 25 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Sustained a single stroke
Key exclusion criteria (1 listed)
- Severe spasticity or contractures (2 or less in the CMSA) or any other musculoskeletal or neuromuscular disorders that compromise sensation or other neuromuscular parameters will be excluded from the study. 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Hand Therapy using the MyHand SystemThe MyHandTM System is a smart-mechatronic device programmed with proprietary hand function training regiments (protocols) based on deep research in neuroplasticity. It 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. Participants will undergo a 2-hour training session, 2-3 days per week, over 12 weeks, for a total of 30 sessions. Hand function therapy will be administered in a specific and gamified manner to enhance rehabilitation of the hand and provide participants with greater opportunity to regain hand function over the course of the study. | Device | Neurorehabilitation of the Hand |
Primary outcome
the Chedoke Arm and Hand Activity Inventory -9 (CAHAI-9)- Change is being assessed
Time frame: Baseline- before beginning the treatment, INTRA- after the completion of 15 treatment sessions and Post treatment- after the conclusion of 30 treatment sessions
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 Test- Change is being assessed
Time frame: Baseline- before beginning the treatment, INTRA- after the completion of 15 treatment sessions and Post treatment- after the conclusion of 30 treatment sessions
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.
The Motor Activity Log- Change is being assessed
Time frame: Baseline- before beginning the treatment, INTRA- after the completion of 15 treatment sessions and Post treatment- after the conclusion of 30 treatment sessions
Estimates how much and how well a participant is able to use their affected upper limb. The MAL is a 30 item questionnaire administered in through a semi-structured interview between the participant and a trained clinician.
the NASA-Task Load Index (NASA-TLX)- Change is being assessed
Time frame: After each treatment session
an assessment tool used to evaluate a participants perceived cognitive load during a session. The NASA-TLX has six sub-scales; mental demand, temporal demand, frustration, performance, effort and physical demand. The NASA-TLX scores, time taken to complete a level, game score and verbal language references made during gameplay will be used to estimate engagement.
European Quality of Life Five Dimension Questionnaire (EQ-5D)- Change is being assessed
Time frame: Baseline- before beginning the treatment and Post treatment- after the conclusion of 30 treatment sessions
To measure participants perceived quality of life through a questionnaire.
3 secondary outcomes
Finger Goniometry- Change is being assessed
Time frame: Baseline- before beginning the treatment, INTRA- after the completion of 15 treatment sessions and Post treatment- after the conclusion of 30 treatment sessions
Grip Dynamometry- Change is being assessed
Time frame: Baseline- before beginning the treatment, INTRA- after the completion of 15 treatment sessions and Post treatment- after the conclusion of 30 treatment sessions
Pinch Dynamometry- Change is being assessed
Time frame: Baseline- before beginning the treatment, INTRA- after the completion of 15 treatment sessions and Post treatment- after the conclusion of 30 treatment sessions
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Apr 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Hand Therapy using the MyHand System in people with Stroke and Engagement, Patient, run by IRegained Inc. at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 3 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Amy Doan, PhD Student (705-675-1151 ext. 2351, adoan@laurentian.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
the Chedoke Arm and Hand Activity Inventory -9 (CAHAI-9)- Change is being assessed (time frame: Baseline- before beginning the treatment, INTRA- after the completion of 15 treatment sessions and Post treatment- after the conclusion of 30 treatment sessions). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Apr 2023.