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Clinical Trials/NCT06754072
NCT06754072CompletedNot Applicable

Virtual Reality-Based Hand Rehabilitation for Post-Surgical Degenerative Cervical Myelopathy: A Pilot Study

Medical College of Wisconsin2 sites in 1 country25 target enrollmentStarted: July 19, 2023Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
25
Locations
2
Primary Endpoint
Jebsen-Taylor Hand Function Test

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Na
Intervention Model
Single Group
Primary Purpose
Treatment
Masking
None

Eligibility Criteria

Ages
18 Years to 85 Years (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

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).

Outcomes

Primary Outcomes

Jebsen-Taylor Hand Function Test

Time Frame: Baseline, post-training and follow-up.

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.

Secondary Outcomes

  • 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.)
  • Touch sensitivity(Baseline, post-training (1 week after VK training), and 4-week follow-up ( 4 weeks after VK training).)
  • EuroQol 5-Dimension score(Baseline, post-training and follow-up.)
  • Short Form-36 Health Survey version 2(Baseline, post-training and follow-up.)
  • Modified Japanese Orthopedic Association scale(Baseline, post-training and follow-up.)
  • Myelopathy Disability Index(Baseline, post-training and follow-up.)

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Aditya Vedantam

Associate Professor

Medical College of Wisconsin

Study Sites (2)

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