Clinical trial NCT06754072: Hand Dexterity Training in Degenerative Cervical Myelopathy (DCM)
Official title: Virtual Reality-Based Hand Rehabilitation for Post-Surgical Degenerative Cervical Myelopathy: A Pilot Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Degenerative Cervical Myelopathy
Keywords: degenerative cervical myelopathy
virtual reality
hand dexterity
post-surgical rehabilitation
neurorehabilitation
cervical spine
eeg
Lead sponsor: Medical College of Wisconsin
Sponsor class: OTHER
Collaborators: name: Marquette University
name: North Carolina State University
First posted: 2024-12-31
Enrollment: 25
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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).

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).

Primary outcomes:
measure: Jebsen-Taylor Hand Function Test
timeFrame: Baseline, post-training and follow-up.
Secondary outcomes:
measure: Quantitative Electroencephalograms (qEEG)
timeFrame: Baseline, post-training and follow-up.
measure: Nine-Hole Peg Test (9HPT)
timeFrame: Baseline, post-training and follow-up.
measure: Box and Blocks Test (BBT)
timeFrame: Baseline, post-training and follow-up.
measure: QuickDASH
timeFrame: Baseline, post-training and follow-up.
measure: Three-point pinch strength
timeFrame: Baseline, post-training and follow-up.
measure: Touch sensitivity
timeFrame: Baseline, post-training (1 week after VK training), and 4-week follow-up ( 4 weeks after VK training).
measure: EuroQol 5-Dimension score
timeFrame: Baseline, post-training and follow-up.
measure: Short Form-36 Health Survey version 2
timeFrame: Baseline, post-training and follow-up.
measure: Modified Japanese Orthopedic Association scale
timeFrame: Baseline, post-training and follow-up.
measure: Myelopathy Disability Index
timeFrame: Baseline, post-training and follow-up.
Other outcomes:
Locations:
city: Milwaukee
country: United States
facility: Marquette University
state: Wisconsin
Study officials:
affiliation: Medical College of Wisconsin
name: Aditya Vedantam, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.