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NCT Number: NCT06062693

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

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.

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Key information

Conditions

Stroke Autoimmune Diseases Autoimmune Diseases of the Nervous System Basal Ganglia Diseases Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Demyelinating Autoimmune Diseases, CNS Demyelinating Diseases Immune System Diseases Movement Disorders Multiple Sclerosis Nervous System Diseases Neurodegenerative Diseases Parkinson Disease Parkinsonian Disorders Synucleinopathies Vascular Diseases

Age range

18 year–99 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Luzerner Kantonsspital

Lucerne, 6000, Switzerland

Location status: Recruiting

Location contact

Manuela Pastore, PhD

CONTACT

[email protected]

0412057220

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

smart sensor egg training

Device

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

Primary outcomes

  1. 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.

Secondary outcomes

  1. fine finger movements

    Time frame: 3 weeks

    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.

  2. grip strength

    Time frame: 3 weeks

    The handheld JAMAR dynamometer measures the grip strength. kg will be measured.

  3. cognition

    Time frame: baseline

    Montreal Cognitive Assessment (MOCA): Cognitive screening tool with a scale from 0 - 30 points. A higher score means a better outcome.

  4. executive function

    Time frame: 3 weeks

    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.

  5. executive function

    Time frame: 3 weeks

    Stroop-test: Results are reported as the number of seconds required to complete the task; therefore, higher scores reveal greater impairment.

  6. self-reported dexterity related problems in daily living for PD

    Time frame: 3 weeks

    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.

  7. self-reported arm and hand function related problems in patients with MS

    Time frame: 3 weeks

    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.

  8. Arm and hand function in stroke patients

    Time frame: 3 weeks

    Patients with stroke: Upper limb limos: Mesures arm and hand function in ADL.

Study contacts

Contact information is provided by the study sponsor or research team.

Cornelia Cox

CONTACT

[email protected]

Manuela Pastore, PhD

CONTACT

[email protected]

+41412057220

Sponsors and collaborators

Lead sponsor

Luzerner Kantonsspital

Other

Registry information

Important dates

Study start
2023
Primary completion
2027
Study completion
2027
First posted
Oct 2, 2023
Registry last updated
Oct 2, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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