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

September 28, 2023 updated by: Luzerner Kantonsspital
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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Estimated)

160

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
3 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
3 weeks
grip strength
Time Frame: 3 weeks
The handheld JAMAR dynamometer measures the grip strength. kg will be measured.
3 weeks
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.
baseline
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.
3 weeks
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.
3 weeks
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.
3 weeks
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.
3 weeks
Arm and hand function in stroke patients
Time Frame: 3 weeks
Patients with stroke: Upper limb limos: Mesures arm and hand function in ADL.
3 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Luzerner Kantonsspital

Investigators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 1, 2023

Primary Completion (Estimated)

August 30, 2027

Study Completion (Estimated)

August 30, 2027

Study Registration Dates

First Submitted

September 4, 2023

First Submitted That Met QC Criteria

September 28, 2023

First Posted (Actual)

October 2, 2023

Study Record Updates

Last Update Posted (Actual)

October 2, 2023

Last Update Submitted That Met QC Criteria

September 28, 2023

Last Verified

September 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2022-02300

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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