NCT06062693

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
160

participants targeted

Target at P75+ for not_applicable stroke

Timeline
16mo left

Started Jun 2023

Longer than P75 for not_applicable stroke

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress70%
Jun 2023Aug 2027

Study Start

First participant enrolled

June 1, 2023

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

September 4, 2023

Completed
28 days until next milestone

First Posted

Study publicly available on registry

October 2, 2023

Completed
3.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 30, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 30, 2027

Last Updated

October 2, 2023

Status Verified

September 1, 2023

Enrollment Period

4.2 years

First QC Date

September 4, 2023

Last Update Submit

September 28, 2023

Conditions

Keywords

dexteritytraining

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (8)

  • fine finger movements

    3 weeks

  • grip strength

    3 weeks

  • cognition

    baseline

  • executive function

    3 weeks

  • executive function

    3 weeks

  • +3 more secondary outcomes

Study Arms (1)

smart sensor egg training

EXPERIMENTAL

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

Interventions

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

smart sensor egg training

Eligibility Criteria

Age18 Years - 99 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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
  • healthy subject
  • written and signed informed consent
  • no self-reported hand function problems

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Luzerner Kantonsspital

Lucerne, 6000, Switzerland

RECRUITING

MeSH Terms

Conditions

StrokeMultiple SclerosisParkinson Disease

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular DiseasesDemyelinating Autoimmune Diseases, CNSAutoimmune Diseases of the Nervous SystemDemyelinating DiseasesAutoimmune DiseasesImmune System DiseasesParkinsonian DisordersBasal Ganglia DiseasesMovement DisordersSynucleinopathiesNeurodegenerative Diseases

Study Officials

  • Tim Vanbellingen, Prof. Dr. phil.

    Luzerner Kantonsspital, Universität Bern

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Manuela Pastore, PhD

CONTACT

Cornelia Cox

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Model Details: sensor-home-based hand training for MS, PD, stroke or control group
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 4, 2023

First Posted

October 2, 2023

Study Start

June 1, 2023

Primary Completion (Estimated)

August 30, 2027

Study Completion (Estimated)

August 30, 2027

Last Updated

October 2, 2023

Record last verified: 2023-09

Data Sharing

IPD Sharing
Will not share

Locations