New Interactive Sensor-home-based Hand Training to Improve Dexterity

Stroke Clinical Trial

Official title:

New Interactive Sensor-home-based Hand Training to Improve Dexterity

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06062693
• Other study ID #: 2022-02300
• Status: Recruiting
• Phase: N/A
• Start date: June 1, 2023
• Est. completion date: August 30, 2027

Study information

• Verified date: September 2023
• Source: Luzerner Kantonsspital
• Contact: Manuela Pastore, PhD
• Phone: +41412057220
• Email: manuela.pastore[@]luks.ch
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 160
• Est. completion date: August 30, 2027
• Est. primary completion date: August 30, 2027
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 99 Years

Eligibility

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.

Related Conditions & MeSH terms

• Multiple Sclerosis
• Parkinson Disease
• Stroke

Intervention

Device:
• smart sensor egg training
The portable hand trainer has three principal functionalities: (I) Grasping, (II) Pronosupination, and (III) wrist and finger extension. Different exercises can be done.

Locations

Country	Name	City	State
Switzerland	Luzerner Kantonsspital	Lucerne

Sponsors (1)

Lead Sponsor	Collaborator
Luzerner Kantonsspital

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	3 weeks
Secondary	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.	3 weeks
Secondary	grip strength	The handheld JAMAR dynamometer measures the grip strength. kg will be measured.	3 weeks
Secondary	cognition	Montreal Cognitive Assessment (MOCA): Cognitive screening tool with a scale from 0 - 30 points. A higher score means a better outcome.	baseline
Secondary	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.	3 weeks
Secondary	executive function	Stroop-test: Results are reported as the number of seconds required to complete the task; therefore, higher scores reveal greater impairment.	3 weeks
Secondary	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.	3 weeks
Secondary	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.	3 weeks
Secondary	Arm and hand function in stroke patients	Patients with stroke: Upper limb limos: Mesures arm and hand function in ADL.	3 weeks