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

Sponsor
Luzerner Kantonsspital (Other)
Overall Status
Recruiting
CT.gov ID
NCT06062693
Collaborator
(none)
160
1
1
51
3.1

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Device: smart sensor egg training
N/A

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

Study Type:
Interventional
Anticipated Enrollment :
160 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Intervention Model Description:
sensor-home-based hand training for MS, PD, stroke or control groupsensor-home-based hand training for MS, PD, stroke or control group
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
New Interactive Sensor-home-based Hand Training to Improve Dexterity
Actual Study Start Date :
Jun 1, 2023
Anticipated Primary Completion Date :
Aug 30, 2027
Anticipated Study Completion Date :
Aug 30, 2027

Arms and Interventions

Arm Intervention/Treatment
Experimental: smart sensor egg training

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.

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.

Outcome Measures

Primary Outcome Measures

  1. hand dexterity [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 Outcome Measures

  1. fine finger movements [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 [3 weeks]

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

  3. cognition [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 [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 [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 [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 [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 [3 weeks]

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

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 99 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Luzerner Kantonsspital Lucerne Switzerland 6000

Sponsors and Collaborators

  • Luzerner Kantonsspital

Investigators

  • Principal Investigator: Tim Vanbellingen, Prof. Dr. phil., Luzerner Kantonsspital, Universität Bern

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Luzerner Kantonsspital
ClinicalTrials.gov Identifier:
NCT06062693
Other Study ID Numbers:
  • 2022-02300
First Posted:
Oct 2, 2023
Last Update Posted:
Oct 2, 2023
Last Verified:
Sep 1, 2023
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Luzerner Kantonsspital
Additional relevant MeSH terms:

Study Results

No Results Posted as of Oct 2, 2023