StrokeNCT06062693
New Interactive Sensor-home-based Hand Training to Improve Dexterity
A study testing smart sensor egg training in people with Stroke and Multiple Sclerosis, run by Luzerner Kantonsspital at 1 site in Switzerland.
Trial summary
Primary objective of this study is to explore the impact of a 3-week upper limb hand function training in patients with PD, MS or stroke. The benefits on hand function of this training program will be evaluated. The hypothesize is that the 3-week upper limb hand function training improves finger dexterity. Read more about this study
- Who is it for?
- Ages 18 to 99 yearsHealthy volunteers can take part
- Conditions the study is for
- Stroke, Multiple Sclerosis, Parkinson Disease
- What is being tested?
- smart sensor egg training
- Type of treatment
- Pill or oral medicine, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 160 participants
- Where
- 1 siteSwitzerland
- Study dates
- 1 Jun 2023to 30 Aug 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 to 99 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patients with confirmed PD, according to UK Brain bank Criteria (Hughes et al., 1992) or
- MS patients with relapsing-remitting MS (RRMS), secondary-progressive MS (SPMS) or primary progressive MS (PPMS) according to the revised McDonald's criteria or
- subacute stroke
- written and signed informed consent
- self-reported hand function problems
- or
Show all 9Show fewer
- healthy subject
- written and signed informed consent
- no self-reported hand function problems
Who cannot join
- MoCA <21/30
- psychiatric disease
- participation on other interventional trials
- Inability to follow the procedures of the study, e.g. due to language problems, psychological disorders, dementia, etc.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Cornelia Cox contact
Switzerland1 site, 1 recruiting
- Recruiting
Luzerner Kantonsspital
Lucerne, 6000
Manuela Pastore, PhD, 0412057220, manuela.pastore@luks.ch
About this study
Primary objective of this study is to explore the impact of a 3-week upper limb hand function training in patients with PD, MS or stroke. The benefits on hand function of this training program will be evaluated. The hypothesize is that the 3-week upper limb hand function training improves finger dexterity.
Read the detailed description
Patients with Parkinson's disease (PD), multiple sclerosis (MS) or stroke often suffer from significantly decreased coordination and have difficulties with precise hand/finger movements during the performance of both basic activities of daily living (ADL), such as dressing, grooming as well as higher ADL, such as cooking, shopping and regular medication intake. The investigators explore the effects of a new, interactive, sensor-home-based upper limb hand training on upper limb related ADL in patients with PD, MS or stroke.
- Conditions
- Stroke, Multiple Sclerosis, Parkinson Disease
- Being tested
- smart sensor egg training
- Keywords
- dexterity, training
- Medical subject headings
- Stroke, Multiple Sclerosis, Parkinson Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
smart sensor egg trainingDevice
The portable hand trainer has three principal functionalities: (I) Grasping, (II) Pronosupination, and (III) wrist and finger extension. Different exercises can be done.
| Study group | Role | What they receive |
|---|---|---|
| smart sensor egg training | Experimental | An interactive hand trainer with integrated sensors was developed and can be used as input devices to a training which runs on the smartphone or tablet computer to train different finger, hand, and wrist functions. Receives: Device: smart sensor egg training |
What is being measured
The primary outcome is the main question the study is designed to answer.
hand dexterity
Nine Hole Peg test (9-HPT): The 9-HPT is a standardized, well established, and reliable measure of hand dexterity in patients with PD, MS, or stroke. seconds will be measured.
Measured: 3 weeks
Secondary outcomes (8)
fine finger movements
Coin rotation task (CRT): The CRT measures fine coordinated finger movements and is a suitable and valid dexterity test in patients with PD, MS, or stroke. The seconds for 20 halfturns will be measured.
Measured: 3 weeks
grip strength
The handheld JAMAR dynamometer measures the grip strength. kg will be measured.
Measured: 3 weeks
cognition
Montreal Cognitive Assessment (MOCA): Cognitive screening tool with a scale from 0 - 30 points. A higher score means a better outcome.
Measured: baseline
executive function
Trail Making Tests (TMT) parts A \& B. Results for both TMT A and B are reported as the number of seconds required to complete the task; therefore, higher scores reveal greater impairment.
Measured: 3 weeks
executive function
Stroop-test: Results are reported as the number of seconds required to complete the task; therefore, higher scores reveal greater impairment.
Measured: 3 weeks
self-reported dexterity related problems in daily living for PD
Patients with PD: Dexterity Questionnaire 24 (DextQ-24): This questionnaire is a standardized patient self-rated outcome measure (PROM) for evaluating dexterity related ADL in PD. score range 24-96, higher scores mean more dexterity problems.
Measured: 3 weeks
self-reported arm and hand function related problems in patients with MS
Patients with MS: The Arm Function in Multiple Sclerosis Questionnaire (AMSQ): This questionnaire is a standardized patient self-rated outcome measure (PROM) for evaluating arm and hand function in patients with MS. Containing 31 items with a range of 1 - 100 points. Higher scores indicate more limitations in hand and arm function.
Measured: 3 weeks
Arm and hand function in stroke patients
Patients with stroke: Upper limb limos: Mesures arm and hand function in ADL.
Measured: 3 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Oct 2023
- Study start1 Jun 2023
- Primary completion30 Aug 2027 (estimated)
- Study completion30 Aug 2027 (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
- Model description
- sensor-home-based hand training for MS, PD, stroke or control group
- Masking
- None (open label)
- Enrolment
- 160 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Luzerner Kantonsspital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Tim Vanbellingen, Prof. Dr. phil., Principal investigator, Luzerner Kantonsspital, Universität Bern
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06062693
- Sponsor's protocol ID
- 2022-02300
- Status last verified
- Sep 2023
- First submitted
- 4 Sep 2023
- Last updated
- 2 Oct 2023
- Results posted
- No
- Data monitoring committee
- Yes
- 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 2 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- New Interactive Sensor-home-based Hand Training to Improve Dexterity
- ClinicalTrials.gov ID
- NCT06062693
- Acronym / sponsor ID
- 2022-02300
- Conditions
- Stroke, Multiple Sclerosis, Parkinson Disease
- Keywords
- dexterity, training
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 160 participants (estimated)
- Lead sponsor
- Luzerner KantonsspitalUniversity, hospital or other
- Study start
- 1 Jun 2023 (actual)
- Primary completion
- 30 Aug 2027 (estimated)
- Study completion
- 30 Aug 2027 (estimated)
- First posted
- 2 Oct 2023 (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.
Primary objective of this study is to explore the impact of a 3-week upper limb hand function training in patients with PD, MS or stroke. The benefits on hand function of this training program will be evaluated. The hypothesize is that the 3-week upper limb hand function training improves finger dexterity.
Detailed description
Patients with Parkinson's disease (PD), multiple sclerosis (MS) or stroke often suffer from significantly decreased coordination and have difficulties with precise hand/finger movements during the performance of both basic activities of daily living (ADL), such as dressing, grooming as well as higher ADL, such as cooking, shopping and regular medication intake. The investigators explore the effects of a new, interactive, sensor-home-based upper limb hand training on upper limb related ADL in patients with PD, MS or stroke.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- sensor-home-based hand training for MS, PD, stroke or control group
| Arm | Type | Receives |
|---|---|---|
| smart sensor egg training | Experimental | Device: smart sensor egg trainingAn interactive hand trainer with integrated sensors was developed and can be used as input devices to a training which runs on the smartphone or tablet computer to train different finger, hand, and wrist functions. |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Patients with confirmed PD, according to UK Brain bank Criteria (Hughes et al., 1992) or
- MS patients with relapsing-remitting MS (RRMS), secondary-progressive MS (SPMS) or primary progressive MS (PPMS) according to the revised McDonald's criteria or
- subacute stroke
- written and signed informed consent
- self-reported hand function problems
Key exclusion criteria (4 listed)
- MoCA <21/30
- psychiatric disease
- participation on other interventional trials
- Inability to follow the procedures of the study, e.g. due to language problems, psychological disorders, dementia, etc.
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 |
|---|---|---|
| smart sensor egg trainingThe portable hand trainer has three principal functionalities: (I) Grasping, (II) Pronosupination, and (III) wrist and finger extension. Different exercises can be done. | Device | smart sensor egg training |
Primary outcome
hand dexterity
Time frame: 3 weeks
Nine Hole Peg test (9-HPT): The 9-HPT is a standardized, well established, and reliable measure of hand dexterity in patients with PD, MS, or stroke. seconds will be measured.
8 secondary outcomes
fine finger movements
Time frame: 3 weeks
grip strength
Time frame: 3 weeks
cognition
Time frame: baseline
executive function
Time frame: 3 weeks
executive function
Time frame: 3 weeks
self-reported dexterity related problems in daily living for PD
Time frame: 3 weeks
self-reported arm and hand function related problems in patients with MS
Time frame: 3 weeks
Arm and hand function in stroke patients
Time frame: 3 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Oct 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.
Cornelia Cox contact
Tim Vanbellingen, Prof. Dr. phil. principal investigator
Luzerner Kantonsspital, Universität Bern
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing smart sensor egg training in people with Stroke and Multiple Sclerosis, run by Luzerner Kantonsspital at 1 site in Switzerland.
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 9 inclusion and 4 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: looking for participants now, as of the sponsor's last update on 2 Oct 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 Switzerland. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Manuela Pastore, PhD (+41412057220, manuela.pastore@luks.ch), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
hand dexterity (time frame: 3 weeks). 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 2 Oct 2023.