Back to resultsNew Interactive Sensor-home-based Hand Training to Improve Dexterity
Primary Purpose
Stroke, Multiple Sclerosis, Parkinson Disease
Status
Recruiting
Phase
Not Applicable
Locations
Switzerland
Study Type
Interventional
Intervention
smart sensor egg training
Sponsored by
About this trial
This is an interventional treatment trial for Stroke focused on measuring dexterity, training
Eligibility Criteria
Inclusion Criteria: 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 healthy subject written and signed informed consent no self-reported hand function problems Exclusion Criteria: 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.
Sites / Locations
- Luzerner KantonsspitalRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
smart sensor egg training
Arm Description
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.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
grip strength
The handheld JAMAR dynamometer measures the grip strength. kg will be measured.
cognition
Montreal Cognitive Assessment (MOCA): Cognitive screening tool with a scale from 0 - 30 points. A higher score means a better outcome.
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.
executive function
Stroop-test: Results are reported as the number of seconds required to complete the task; therefore, higher scores reveal greater impairment.
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.
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.
Arm and hand function in stroke patients
Patients with stroke: Upper limb limos: Mesures arm and hand function in ADL.
Full Information
NCT ID
NCT06062693
First Posted
September 4, 2023
Last Updated
September 28, 2023
Sponsor
Luzerner Kantonsspital
1. Study Identification
Unique Protocol Identification Number
NCT06062693
Brief Title
New Interactive Sensor-home-based Hand Training to Improve Dexterity
Official Title
New Interactive Sensor-home-based Hand Training to Improve Dexterity
Study Type
Interventional
2. Study Status
Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
June 1, 2023 (Actual)
Primary Completion Date
August 30, 2027 (Anticipated)
Study Completion Date
August 30, 2027 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Luzerner Kantonsspital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke, Multiple Sclerosis, Parkinson Disease
Keywords
dexterity, training
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
sensor-home-based hand training for MS, PD, stroke or control group
Masking
None (Open Label)
Allocation
N/A
Enrollment
160 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
smart sensor egg training
Arm Type
Experimental
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
smart sensor egg training
Intervention Description
The portable hand trainer has three principal functionalities: (I) Grasping, (II) Pronosupination, and (III) wrist and finger extension. Different exercises can be done.
Primary Outcome Measure Information:
Title
hand dexterity
Description
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.
Time Frame
3 weeks
Secondary Outcome Measure Information:
Title
fine finger movements
Description
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.
Time Frame
3 weeks
Title
grip strength
Description
The handheld JAMAR dynamometer measures the grip strength. kg will be measured.
Time Frame
3 weeks
Title
cognition
Description
Montreal Cognitive Assessment (MOCA): Cognitive screening tool with a scale from 0 - 30 points. A higher score means a better outcome.
Time Frame
baseline
Title
executive function
Description
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.
Time Frame
3 weeks
Title
executive function
Description
Stroop-test: Results are reported as the number of seconds required to complete the task; therefore, higher scores reveal greater impairment.
Time Frame
3 weeks
Title
self-reported dexterity related problems in daily living for PD
Description
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.
Time Frame
3 weeks
Title
self-reported arm and hand function related problems in patients with MS
Description
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.
Time Frame
3 weeks
Title
Arm and hand function in stroke patients
Description
Patients with stroke: Upper limb limos: Mesures arm and hand function in ADL.
Time Frame
3 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
99 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
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
healthy subject
written and signed informed consent
no self-reported hand function problems
Exclusion Criteria:
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Manuela Pastore, PhD
Phone
+41412057220
Email
manuela.pastore@luks.ch
First Name & Middle Initial & Last Name or Official Title & Degree
Cornelia Cox
Email
cornelia.cox@luks.ch
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Tim Vanbellingen, Prof. Dr. phil.
Organizational Affiliation
Luzerner Kantonsspital, Universität Bern
Official's Role
Principal Investigator
Facility Information:
Facility Name
Luzerner Kantonsspital
City
Lucerne
ZIP/Postal Code
6000
Country
Switzerland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Manuela Pastore, PhD
Phone
0412057220
Email
manuela.pastore@luks.ch
12. IPD Sharing Statement
Plan to Share IPD
No
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