NCT06754072

Brief Summary

This clinical study aimed to evaluate the effectiveness of a virtual reality-based training intervention for improving hand dexterity and promoting neuroplasticity in individuals with Degenerative Cervical Myelopathy (DCM) after surgical decompression. Participants completed a 4-week training program using the Virtual Keyboard (VK) system, which facilitated repetitive, individualized finger movements in a virtual environment. Outcomes were measured pre- and post-training to quantify improvements in hand dexterity, quality of life, and cortical motor activity.

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 not_applicable

Timeline
Completed

Started Jul 2023

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

Study Start

First participant enrolled

July 19, 2023

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 23, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 23, 2024

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

December 17, 2024

Completed
14 days until next milestone

First Posted

Study publicly available on registry

December 31, 2024

Completed
Last Updated

December 31, 2024

Status Verified

December 1, 2024

Enrollment Period

1.3 years

First QC Date

December 17, 2024

Last Update Submit

December 20, 2024

Conditions

Keywords

degenerative cervical myelopathyvirtual realityhand dexteritypost-surgical rehabilitationneurorehabilitationcervical spineeeg

Outcome Measures

Primary Outcomes (1)

  • Jebsen-Taylor Hand Function Test

    The Jebsen-Taylor Hand Function Test (JTHFT) is a standardized test used to assess hand function during everyday activities. It consists of seven timed subtests, such as writing, card turning, and object manipulation. The outcome is recorded as the time taken to complete each task in seconds, where lower times indicate better hand function.

    Baseline, post-training and follow-up.

Secondary Outcomes (10)

  • Quantitative Electroencephalograms (qEEG)

    Baseline, post-training and follow-up.

  • Nine-Hole Peg Test (9HPT)

    Baseline, post-training and follow-up.

  • Box and Blocks Test (BBT)

    Baseline, post-training and follow-up.

  • QuickDASH

    Baseline, post-training and follow-up.

  • Three-point pinch strength

    Baseline, post-training and follow-up.

  • +5 more secondary outcomes

Study Arms (1)

Virtual Reality Training Group

EXPERIMENTAL

Participants completed virtual reality-based hand training using the virtual keyboard system.

Other: Virtual Keyboard (VK) System

Interventions

Participants underwent a 4-week training program comprising 12 one-hour sessions to enhance finger individuation and motor control using a virtual reality platform.

Virtual Reality Training Group

Eligibility Criteria

Age18 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Diagnosed with Degenerative Cervical Myelopathy.
  • Completed cervical spine surgery within 6 months.
  • Modified Japanese Orthopaedic Association (mJOA) upper limb motor score between 1-4.

You may not qualify if:

  • Pregnancy.
  • History of brain or upper extremity surgery within the past year.
  • Significant arm/hand pain limiting movement.
  • Complete paralysis of the hands (mJOA=0).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Marquette University

Milwaukee, Wisconsin, 53233, United States

Location

Related Publications (1)

  • Thielbar KO, Lord TJ, Fischer HC, Lazzaro EC, Barth KC, Stoykov ME, Triandafilou KM, Kamper DG. Training finger individuation with a mechatronic-virtual reality system leads to improved fine motor control post-stroke. J Neuroeng Rehabil. 2014 Dec 26;11:171. doi: 10.1186/1743-0003-11-171.

    PMID: 25542201BACKGROUND

MeSH Terms

Interventions

Drug Delivery Systems

Intervention Hierarchy (Ancestors)

Drug TherapyTherapeutics

Study Officials

  • Aditya Vedantam, MD

    Medical College of Wisconsin

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

December 17, 2024

First Posted

December 31, 2024

Study Start

July 19, 2023

Primary Completion

October 23, 2024

Study Completion

October 23, 2024

Last Updated

December 31, 2024

Record last verified: 2024-12

Data Sharing

IPD Sharing
Will not share

Due to confidentiality and privacy concerns, individual participant data (IPD) will not be shared with other researchers. All study data will be presented in aggregate form in the final published results, with appropriate measures taken to ensure participant anonymity and data security.

Locations