Hand Dexterity Training in Degenerative Cervical Myelopathy (DCM)

NCT ID: NCT06754072

Last Updated: 2024-12-31

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 25 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-07-19
• Study Completion Date: 2024-10-23

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.

Detailed Description

Degenerative Cervical Myelopathy (DCM) is a leading cause of non-traumatic spinal cord injury, often resulting in impaired hand dexterity and diminished quality of life. Despite surgical decompression being the primary treatment, over 30% of individuals experience persistent functional disability due to a lack of targeted post-surgical rehabilitative interventions. This study sought to address this clinical gap by implementing and evaluating a virtual reality-based hand training intervention.

The central hypothesis was that an intensive, individualized training program using the Virtual Keyboard (VK) system would improve hand dexterity in individuals with DCM and that these functional gains would be supported by measurable changes in cortical motor activity.

Study Design

This single-arm interventional study recruited participants who had undergone cervical spine surgery within six months. A total of 25 participants were enrolled, each completing:

A 4-week training program consisting of 12 one-hour sessions using the VK system. The system provided engaging, interactive tasks designed to promote finger individuation and precise motor control through real-time visual and auditory feedback.

Pre- and post-training evaluations assessing functional, neurophysiological, and quality-of-life outcomes.

Specific Aims- Aim 1: Quantify improvements in hand dexterity after the training intervention. Hypothesis: Training with the VK system would significantly improve hand function as measured by the Jebsen-Taylor Hand Function Test (JTHFT) and other clinical metrics.

Approach: Baseline, post-training, and follow-up evaluations measured outcomes including JTHFT scores, pinch strength, and sensorimotor tests.

Aim 2: Assess neuroplastic changes associated with training. Hypothesis: The training program would enhance cortical motor activation and connectivity, reflected in changes in beta-band event-related desynchronization (ERD) and coherence measured via quantitative EEG (qEEG).

Approach: Participants underwent qEEG during finger-tapping tasks at each evaluation, and EEG data were analyzed for changes in cortical activation patterns.

Outcomes and Measures- Primary outcomes included: Improvement in hand function as measured by JTHFT scores and related clinical tests.

Changes in cortical motor activity and connectivity, including event-related desynchronization and coherence, derived from qEEG data.

Secondary outcomes included quality-of-life measures (SF-36 physical component score and EuroQol 5D).

Conditions

Degenerative Cervical Myelopathy

Keywords

degenerative cervical myelopathy; virtual reality; hand dexterity; post-surgical rehabilitation; neurorehabilitation; cervical spine; eeg

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Virtual Reality Training Group

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

Group Type: EXPERIMENTAL

Virtual Keyboard (VK) System

Intervention Type: OTHER

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

Interventions

Virtual Keyboard (VK) System

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

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

• 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).

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Marquette University

OTHER

Sponsor Role: collaborator

North Carolina State University

OTHER

Sponsor Role: collaborator

Medical College of Wisconsin

OTHER

Sponsor Role: lead

Responsible Party

Aditya Vedantam

Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Aditya Vedantam, MD

Role: PRINCIPAL_INVESTIGATOR

Medical College of Wisconsin

Locations

Marquette University

Milwaukee, Wisconsin, United States

Countries

United States

References

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.

Reference Type: BACKGROUND

PMID: 25542201 (View on PubMed)

Provided Documents

Document Type: Informed Consent Form

View Document

Other Identifiers

PI: Vedantam

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

PRO00044319

Identifier Type: -

Identifier Source: org_study_id