StrokeNCT05549375
Neurorehabilitation of the Hand
A study testing MyHand System Hand Rehabilitation in people with Stroke, run by IRegained Inc. at 1 site in Canada.
Trial summary
Stroke is the number one cause of adult disability in the world. Due to the neurological damage from stroke, a vast majority of individuals suffer from hand function disability (~70%). Read more about this study
- Who is it for?
- Ages 30 to 85 years
- Conditions the study is for
- Stroke
- What is being tested?
- MyHand System Hand Rehabilitation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteCanada
- Study dates
- 4 Aug 2021to 1 Sep 2021
- 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 30 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- sustained a single stroke
- aged between 30-85 years of age.
Who cannot join
- Participants with severe spasticity or contractures,
- have other musculoskeletal or neuromuscular disorders that compromises sensation or other neuromuscular parameters
- participants who are unable to provide consent to participate
Trial locations and contacts
1 site in 1 country.
About this study
Stroke is the number one cause of adult disability in the world. Due to the neurological damage from stroke, a vast majority of individuals suffer from hand function disability (~70%). To improve hand function and overcome challenges from this disability, IRegained has developed the MyHandTM system, a connected mechatronic device with programmed proprietary hand function training protocols developed through deep research in neuroplasticity that provide targeted hand function therapy. When these therapeutic protocols are provided in a gamified format, it enhances the patient engagement and motivation, thereby enabling effective therapy administration with the required intensity and repetition to improve hand function. Participants who have sustained a stroke 6 months or earlier will be eligible to participate in this study, and will undergo hand function therapy for one 1-hour/session, 5 times/week, over a 3-week duration, for a total of 15 sessions. Therapy will be administered through with specific hand functions in a gamified format to enhance greater function in the hand and thereby help patients gain greater independence in performing activities of daily living. This research project will aim to understand the extent to which this approach to therapy impacts patient motivation and engagement in order to develop the most efficient and effective mode of therapy.
- Conditions
- Stroke
- Being tested
- MyHand System Hand Rehabilitation
- Keywords
- Hand Function, Rehabilitation, Engagement, Motor control
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MyHand System Hand RehabilitationDevice
15 1-hour patient specific sessions using the MyHand System to help improve Hand function in the affected hand of stroke survivors
| Study group | Role | What they receive |
|---|---|---|
| Neurorehabilitation of the Hand | Experimental | Not described Receives: Device: MyHand System Hand Rehabilitation |
What is being measured
The primary outcome is the main question the study is designed to answer.
the Nasa-Task Load Index (NASA-TLX)
an assessment tool used to evaluate the participant's perceived cognitive load during an activity will be used. It has six subscales; mental demand, physical demand, temporal demand, performance, effort, and frustration. To estimate the level of participant engagement, the participants score within the game/intervention, the time taken to complete a level, as well as verbal language references made during gameplay will be utilized along with the NASA-TLX sub-scores
Measured: immediately after each treatment session
ABILHAND- change is being assessed
ABILHAND 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.
Measured: Baseline- prior to intervention and post- intervention- one day after completing the intervention
Jebson Taylor Hand Function Assessment-change is being assessed
7 tasks used to measure participants functional ability with they upper limbs
Measured: Baseline- prior to intervention and post- intervention- one day after completing the intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Sep 2022
- Study start4 Aug 2021
- Primary completion1 Sep 2021
- Study completion1 Sep 2021
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
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- IRegained Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Laurentian University, Health Sciences North
- Responsible party
- Sponsor
- Investigators
- Ratvinder Grewal, Principal investigator, Laurentian University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05549375
- Sponsor's protocol ID
- LUSUON0001
- Status last verified
- Sep 2022
- First submitted
- 28 Jul 2021
- Last updated
- 22 Sep 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 22 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Neurorehabilitation of the Hand
- ClinicalTrials.gov ID
- NCT05549375
- Acronym / sponsor ID
- LUSUON0001
- Conditions
- Stroke
- Keywords
- Hand Function, Rehabilitation, Engagement, Motor control
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- IRegained Inc.Industry (pharma, biotech, devices)
- Collaborators
- Laurentian University, Health Sciences North
- Study start
- 4 Aug 2021 (actual)
- Primary completion
- 1 Sep 2021 (actual)
- Study completion
- 1 Sep 2021 (actual)
- First posted
- 22 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 number one cause of adult disability in the world. Due to the neurological damage from stroke, a vast majority of individuals suffer from hand function disability (~70%). To improve hand function and overcome challenges from this disability, IRegained has developed the MyHandTM system, a connected mechatronic device with programmed proprietary hand function training protocols developed through deep research in neuroplasticity that provide targeted hand function therapy. When these therapeutic protocols are provided in a gamified format, it enhances the patient engagement and motivation, thereby enabling effective therapy administration with the required intensity and repetition to improve hand function. Participants who have sustained a stroke 6 months or earlier will be eligible to participate in this study, and will undergo hand function therapy for one 1-hour/session, 5 times/week, over a 3-week duration, for a total of 15 sessions. Therapy will be administered through with specific hand functions in a gamified format to enhance greater function in the hand and thereby help patients gain greater independence in performing activities of daily living. This research project will aim to understand the extent to which this approach to therapy impacts patient motivation and engagement in order to develop the most efficient and effective mode 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: MyHand System Hand Rehabilitation |
Who may qualify
- Ages
- 30 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- sustained a single stroke
- aged between 30-85 years of age.
Key exclusion criteria (3 listed)
- Participants with severe spasticity or contractures,
- have other musculoskeletal or neuromuscular disorders that compromises sensation or other neuromuscular parameters
- participants who are unable to provide consent to participate
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 |
|---|---|---|
| MyHand System Hand Rehabilitation15 1-hour patient specific sessions using the MyHand System to help improve Hand function in the affected hand of stroke survivors | Device | Neurorehabilitation of the Hand |
Primary outcome
the Nasa-Task Load Index (NASA-TLX)
Time frame: immediately after each treatment session
an assessment tool used to evaluate the participant's perceived cognitive load during an activity will be used. It has six subscales; mental demand, physical demand, temporal demand, performance, effort, and frustration. To estimate the level of participant engagement, the participants score within the game/intervention, the time taken to complete a level, as well as verbal language references made during gameplay will be utilized along with the NASA-TLX sub-scores
ABILHAND- change is being assessed
Time frame: Baseline- prior to intervention and post- intervention- one day after completing the intervention
ABILHAND 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.
Jebson Taylor Hand Function Assessment-change is being assessed
Time frame: Baseline- prior to intervention and post- intervention- one day after completing the intervention
7 tasks used to measure participants functional ability with they upper limbs
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Sep 2022.
- Individual participant dataSharing planned: Undecided
Related trials for Stroke
Not yet recruiting
Temporal Interference Stimulation for Upper-Limb Motor Recovery in Early Subacute Stroke
Acute Ischemic Stroke
RecruitingObservational study
ELATE Study: Evaluating Large-vessel Acute Thrombectomy in Extended Time Window
Acute Ichemic Stroke
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Web-Based Tele-Rehabilitation Using Action Observation and Mirror Therapy for Subacute Stroke: A Randomized Controlled Trial
Stroke, Upper Extremity Paresis
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Early Motor-Cognitive Integrative Training on Cognitive and Motor Performance in Patients With Aneurysmal Subarachnoid Hemorrhage
Subarachnoid Aneurysm Hemorrhage
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Selective Intra-Arterial Hypothermia After Endovascular Treatment for Acute Basilar Artery Occlusion
Acute Ischemic Stroke, Basilar Artery Occlusion
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.
Ratvinder Grewal principal investigator
Laurentian University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing MyHand System Hand Rehabilitation in people with Stroke, 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 2 inclusion and 3 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: finished, as of the sponsor's last update on 22 Sep 2022. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
the Nasa-Task Load Index (NASA-TLX) (time frame: immediately after each treatment session). The study lists 3 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 22 Sep 2022.