StrokeGoHandNCT05321446
GoHand(TM) to Enhance Recovery of Arm and Hand Function Post-Stroke
A study testing GoHand(TM) in people with Stroke, run by McGill University at 1 site in Canada.
Trial summary
This is a proof-of-concept study aimed at contributing evidence towards the need, usability and efficacy potential of the GoHandTM sensor in people with reduced hand function post-stroke. A two group, randomized, proof-of-concept, trial. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Stroke
- What is being tested?
- GoHand(TM)
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 12 participants
- Where
- 1 siteCanada
- Study dates
- 1 Jul 2022to 31 Oct 2022
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Anyone with self-reported difficulties in hand function as indicated by reporting that 2 or more items of the Stroke Impact Scale hand function domain as being somewhat or more difficult to do (as a result of the stroke and not a pre-existing arm problem)
- Capacity to activate the auditory feedback using the GoHand sensor.
Who cannot join
- Stroke more than 2 years ago
- People who get more than 2/6 items incorrect on the Six-Item Screener.
- Pain in affected arm that limits mobility and function.
- Botox in past 3 months for spasticity.
- People who do not think that they could participate in the prescribed 45 minutes per day of arm and hand activities.
Trial locations and contacts
1 site in 1 country.
Ahmed Abou-Sharkh, MSc(PT) contact
Canada1 site
Research Institute of the McGill University Health Center, CORE, 5252 de Maisonneuve
Montreal, Quebec, H4A 3S5
Nancy Mayo, PhD, 5143862711, nancy.mayo@mcgill.ca
Nancy E Mayo, PhD
About this study
This is a proof-of-concept study aimed at contributing evidence towards the need, usability and efficacy potential of the GoHandTM sensor in people with reduced hand function post-stroke. A two group, randomized, proof-of-concept, trial. The outcome is change over a one-month period in movement quality as measured by the GoHand sensor. The intervention period is one month. The intervention to be tested is the GoHand sensor, specifically the auditory feedback provided for an optimal wrist and hand movement during everyday tasks. To standardize the practice sessions, all persons will be taught the GRASP (Graded Repetitive Arm Supplementary Program) which has been shown to be of benefit to people recovering from stroke. The intervention group will practice the GRASP program with the sensor in feedback mode and the control group will practice with the sensor without feedback. The total sample size is 12, 6 per group.
The study will be used to create movement metric algorithms and provide preliminary data for extent of change and usability.
Read the detailed description
Abstract One of the most frustrating and persistent motor sequelae of stroke is poor arm and hand function. There are many therapies for arm function post-stroke. The most effective strategies use repetitive, meaningful movement to promote neuroplasticity to support long lasting improvements in arm function. However, at best, the interventions are only moderately effective in improving impairment related outcomes with little or no carry over into everyday, real-world, activities.
There are two gaps in this area, one is for effective interventions and the second is for methods of measuring outcomes that reflect real-world use of the arm. This study is designed to fill both these gaps with technology. GoHandTM is conceived to be a therapeutic wearable to provide auditory feedback for any voluntary wrist and finger movement. This type of positive auditory feedback is known to stimulate neural connections and, through the process of neural plasticity, imprint the learned movement pattern. The sensor also provides performance feedback that is motivating allowing patients to set and accomplish movement and practice goals and track progress.
The global aim of this project is to develop and validate a sensing and feedback device to the detect disassociated wrist and arm movements and provide auditory feedback for hand movement over a range of starting capacities. The focus is on wrist movement because one of the strongest prognostic indicators for recovery of arm function post-stroke is 20o of active wrist extension and any degree of active finger movement.20 This is a proof-of-concept study aimed at contributing evidence towards the need, usability and efficacy potential of the GoHandTM sensor in people with reduced hand function post-stroke. People with stroke who have arm and hand movement deficits will be invited into a two group, randomized, proof-of-concept, trial. The outcome is change over a one-month period in movement quality as measured by the GoHand sensor. The intervention period is one month. The intervention to be tested is the GoHand sensor, specifically the auditory feedback provided for an optimal wrist and hand movement during everyday tasks. To standardize the practice sessions, all persons will be taught the GRASP (Graded Repetitive Arm Supplementary Program) which has been shown to be of benefit to people recovering from stroke. The intervention group will practice the GRASP program with the sensor in feedback mode and the control group will practice with the sensor without feedback. The total sample size is 12, 6 per group.
The study will be used to create movement metric algorithms and provide preliminary data for extent of change and usability.
- Conditions
- Stroke
- Being tested
- GoHand(TM)
- Keywords
- recovery feedback sensors hand function movement
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GoHand(TM)Device
The GoHand(TM) is a therapeutic wearable that provides positive auditory feedback when the wrist and hand moves optimally during execution of dexterity tests and everyday movements.
| Study group | Role | What they receive |
|---|---|---|
| GoHand Feedback Group | Experimental | Both groups will receive a standardized home practice program, the GRASP (Graded Repetitive Arm Supplementary Program). This is a program that has a standard set of arm and hand movements to be practiced 45 minutes per day over a one month period. The person manipulates objects to practice different hand movements. These are everyday objects and each person will be given a set of these to take home and to keep.
For the Experimental Group, the person will be taught the GRASP program and how to move the wrist and hand optimally to activate the GoHand sensor to hear the sound. Receives: Device: GoHand(TM) |
| GoHand Measurement Group | Sham comparator | For Group 2, the person will be taught GRASP program and how to wear the sensor so it measures movement but does not emit a sound. Receives: Device: GoHand(TM) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in hand movement quality metrics from GoHand sensor.
Angular velocity wrist flexion and extension, coefficient of variation, quaterions, while doing standardized dexterity tests (wrist flexion and extension, Box and Block Test, Nine Hole Peg Test) and a set of functional tasks.
Measured: Change over 1 month
Secondary outcomes (4)
Change in Nine Hole Peg Test (NHPT)
The NHPT is administered by asking the participant to take the pegs from a container, one by one, and placing them into the holes on the board, as quickly as possible. Participants must then remove the pegs from the holes, one by one, and replace them back into the container. Participants are scored based on the time taken to complete the test activity, recorded in seconds. Both hands are tested.
Measured: Change over 1 month
Change in Box and Block Test (BBT)
BBT measures unilateral gross manual dexterity. The BBT is composed of a wooden box (53.7 cm x 25.4 cm x 8.5 cm) divided in two compartments by a partition and 150 blocks (2.5 cm). The BBT administration consists of asking the participant to move, one by one, the maximum number of blocks from one compartment of a box to another of equal size, within 60 seconds. Both hands are tested.
Measured: Change over 1 month
Change in Grip strength
Measured (kg.) for both hands using a hand-held dynamometer (JAMAR).
Measured: Change over 1 month
Change in Stroke Arm Ladder (SF-ARM)
A 20 item index developed using Rasch analysis to measure arm and hand function after stroke. It is classified as a Clinician Reported Outcome (ClinRO) as a clinician rates the quality of movement on an ordinal scale while the participant performs tasks. The SF-ARM measure has been formatted in a manner similar to Computer Adaptive Testing, meaning that the administration of the measure begins at the item representing a middle level of arm and hand function and subsequent items are administered depending on the individuals' responses. In this manner, researchers are able to identify an individuals' exact level of function with the administration of only a fraction of the test items. The result is a shorter, less burdensome and more accurate measure of arm and hand function. The original scoring on a logit scale (-4 to +4) has been transformed to a 0 to 100 scale with 10 points considered clinically meaningful.
Measured: Change over 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Apr 2022
- Study start1 Jul 2022 (estimated)
- Primary completion31 Oct 2022 (estimated)
- Study completion31 Oct 2022 (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
- Device feasibility
- Allocation
- Randomised
- Intervention model
- Sequential
- Model description
- The intervention is positive auditory feedback provided by the device for good wrist movement during completion of different functional tasks. Two different groups are assessed, one with the device and one without in a sequential pre-post design. The groups are not compared.
- Masking
- None (open label)
- Enrolment
- 12 participants (estimated)
Sponsor and investigators
- Lead sponsor
- McGill University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nancy Mayo, McGill University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05321446
- Sponsor's protocol ID
- HBHL Ignite Program 2020
- Acronym
- GoHand
- Status last verified
- Oct 2021
- First submitted
- 20 Oct 2021
- Last updated
- 11 Apr 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- GoHand(TM) to Enhance Recovery of Arm and Hand Function Post-Stroke
- ClinicalTrials.gov ID
- NCT05321446
- Acronym / sponsor ID
- GoHand / HBHL Ignite Program 2020
- Conditions
- Stroke
- Keywords
- recovery feedback sensors hand function movement
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 12 participants (estimated)
- Lead sponsor
- McGill UniversityUniversity, hospital or other
- Study start
- 1 Jul 2022 (estimated)
- Primary completion
- 31 Oct 2022 (estimated)
- Study completion
- 31 Oct 2022 (estimated)
- First posted
- 11 Apr 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.
This is a proof-of-concept study aimed at contributing evidence towards the need, usability and efficacy potential of the GoHandTM sensor in people with reduced hand function post-stroke. A two group, randomized, proof-of-concept, trial. The outcome is change over a one-month period in movement quality as measured by the GoHand sensor. The intervention period is one month. The intervention to be tested is the GoHand sensor, specifically the auditory feedback provided for an optimal wrist and hand movement during everyday tasks. To standardize the practice sessions, all persons will be taught the GRASP (Graded Repetitive Arm Supplementary Program) which has been shown to be of benefit to people recovering from stroke. The intervention group will practice the GRASP program with the sensor in feedback mode and the control group will practice with the sensor without feedback. The total sample size is 12, 6 per group.
The study will be used to create movement metric algorithms and provide preliminary data for extent of change and usability.
Detailed description
Abstract One of the most frustrating and persistent motor sequelae of stroke is poor arm and hand function. There are many therapies for arm function post-stroke. The most effective strategies use repetitive, meaningful movement to promote neuroplasticity to support long lasting improvements in arm function. However, at best, the interventions are only moderately effective in improving impairment related outcomes with little or no carry over into everyday, real-world, activities.
There are two gaps in this area, one is for effective interventions and the second is for methods of measuring outcomes that reflect real-world use of the arm. This study is designed to fill both these gaps with technology. GoHandTM is conceived to be a therapeutic wearable to provide auditory feedback for any voluntary wrist and finger movement. This type of positive auditory feedback is known to stimulate neural connections and, through the process of neural plasticity, imprint the learned movement pattern. The sensor also provides performance feedback that is motivating allowing patients to set and accomplish movement and practice goals and track progress.
The global aim of this project is to develop and validate a sensing and feedback device to the detect disassociated wrist and arm movements and provide auditory feedback for hand movement over a range of starting capacities. The focus is on wrist movement because one of the strongest prognostic indicators for recovery of arm function post-stroke is 20o of active wrist extension and any degree of active finger movement.20 This is a proof-of-concept study aimed at contributing evidence towards the need, usability and efficacy potential of the GoHandTM sensor in people with reduced hand function post-stroke. People with stroke who have arm and hand movement deficits will be invited into a two group, randomized, proof-of-concept, trial. The outcome is change over a one-month period in movement quality as measured by the GoHand sensor. The intervention period is one month. The intervention to be tested is the GoHand sensor, specifically the auditory feedback provided for an optimal wrist and hand movement during everyday tasks. To standardize the practice sessions, all persons will be taught the GRASP (Graded Repetitive Arm Supplementary Program) which has been shown to be of benefit to people recovering from stroke. The intervention group will practice the GRASP program with the sensor in feedback mode and the control group will practice with the sensor without feedback. The total sample size is 12, 6 per group.
The study will be used to create movement metric algorithms and provide preliminary data for extent of change and usability.
Study design
- Primary purpose
- Device feasibility
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- The intervention is positive auditory feedback provided by the device for good wrist movement during completion of different functional tasks. Two different groups are assessed, one with the device and one without in a sequential pre-post design. The groups are not compared.
| Arm | Type | Receives |
|---|---|---|
| GoHand Feedback Group | Experimental | Device: GoHand(TM)Both groups will receive a standardized home practice program, the GRASP (Graded Repetitive Arm Supplementary Program). This is a program that has a standard set of arm and hand movements to be practiced 45 minutes per day over a one month period. The person manipulates objects to practice different hand movements. These are everyday objects and each person will be given a set of these to take home and to keep. For the Experimental Group, the person will be taught the GRASP program and how to move the wrist and hand optimally to activate the GoHand sensor to hear the sound. |
| GoHand Measurement Group | Sham comparator | Device: GoHand(TM)For Group 2, the person will be taught GRASP program and how to wear the sensor so it measures movement but does not emit a sound. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Anyone with self-reported difficulties in hand function as indicated by reporting that 2 or more items of the Stroke Impact Scale hand function domain as being somewhat or more difficult to do (as a result of the stroke and not a pre-existing arm problem)
- Capacity to activate the auditory feedback using the GoHand sensor.
Key exclusion criteria (5 listed)
- Stroke more than 2 years ago
- People who get more than 2/6 items incorrect on the Six-Item Screener.
- Pain in affected arm that limits mobility and function.
- Botox in past 3 months for spasticity.
- People who do not think that they could participate in the prescribed 45 minutes per day of arm and hand activities.
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 |
|---|---|---|
| GoHand(TM)The GoHand(TM) is a therapeutic wearable that provides positive auditory feedback when the wrist and hand moves optimally during execution of dexterity tests and everyday movements. | Device | GoHand Feedback Group, GoHand Measurement Group |
Primary outcome
Change in hand movement quality metrics from GoHand sensor.
Time frame: Change over 1 month
Angular velocity wrist flexion and extension, coefficient of variation, quaterions, while doing standardized dexterity tests (wrist flexion and extension, Box and Block Test, Nine Hole Peg Test) and a set of functional tasks.
4 secondary outcomes
Change in Nine Hole Peg Test (NHPT)
Time frame: Change over 1 month
Change in Box and Block Test (BBT)
Time frame: Change over 1 month
Change in Grip strength
Time frame: Change over 1 month
Change in Stroke Arm Ladder (SF-ARM)
Time frame: Change over 1 month
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Apr 2022.
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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.
Ahmed Abou-Sharkh, MSc(PT) contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing GoHand(TM) in people with Stroke, run by McGill University 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 5 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 11 Apr 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. Some participants in this study may receive a placebo. 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 Nancy Mayo, PhD (15143862711, nancy.mayo@mcgill.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in hand movement quality metrics from GoHand sensor. (time frame: Change over 1 month). 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 11 Apr 2022.