NCT05743296

Brief Summary

This study aims to find out the difference in brain activity when performing upper limb exercise tasks through virtual reality-based MOTOCOG equipment for chronic stroke patients.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
25

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Dec 2022

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 22, 2022

Completed
5 days until next milestone

Study Start

First participant enrolled

December 27, 2022

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 20, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 20, 2023

Completed
4 days until next milestone

First Posted

Study publicly available on registry

February 24, 2023

Completed
Last Updated

March 1, 2023

Status Verified

November 1, 2022

Enrollment Period

2 months

First QC Date

December 22, 2022

Last Update Submit

February 27, 2023

Conditions

Stroke

Outcome Measures

Primary Outcomes (1)

  • Fugl-Meyer Assessment Upper Extremity

    Measurement of motor function of upper and lower extremities. The minimum and maximum values are 0 and 66, and higher scores mean a better outcome.

    Baseline

Secondary Outcomes (4)

  • Grip and Tip pinch strength test

    Baseline

  • Box & Block Test

    Baseline

  • 9-hole pegboard test

    Baseline

  • Jebsen-Taylor Hand Function test

    Baseline

Study Arms (1)

Cross-sectional study, no arm

Experimental: Training with the virtual reality program (MOTOCOG) Training consists of 26 minutes task-specific training.

Eligibility Criteria

Age19 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Stroke patients

You may qualify if:

  • Patients aged 19 to 80 years
  • FMA Upper scores more than 25 and less than 58
  • Patients whose lesions do not include stimulation regions
  • Patients with stroke with more than 6 months of onset
  • K-MMSE scores more than 24
  • patients who can Grasp \& release

You may not qualify if:

  • Difficult to communicate due to severe language impairment.
  • Accompanied by an existing serious neurogenic disease
  • Existing significant psychiatric disorders such as major schizophrenia, bipolar disorder

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Samsung Medical Center

Seoul, 06351, South Korea

Location

Related Publications (1)

  • Kim J, Kim E, Lee SH, Lee G, Kim YH. Use of cortical hemodynamic responses in digital therapeutics for upper limb rehabilitation in patients with stroke. J Neuroeng Rehabil. 2024 Jul 10;21(1):115. doi: 10.1186/s12984-024-01404-y.

    PMID: 38987817DERIVED

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 22, 2022

First Posted

February 24, 2023

Study Start

December 27, 2022

Primary Completion

February 20, 2023

Study Completion

February 20, 2023

Last Updated

March 1, 2023

Record last verified: 2022-11

Locations

KR(1)