Degenerative Cervical MyelopathyNCT06754072
Hand Dexterity Training in Degenerative Cervical Myelopathy (DCM)
A study testing Virtual Keyboard (VK) System in people with Degenerative Cervical Myelopathy, run by Medical College of Wisconsin at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Degenerative Cervical Myelopathy
- What is being tested?
- Virtual Keyboard (VK) System
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 1 siteUnited States
- Study dates
- 19 Jul 2023to 23 Oct 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosed with Degenerative Cervical Myelopathy.
- Completed cervical spine surgery within 6 months.
- Modified Japanese Orthopaedic Association (mJOA) upper limb motor score between 1-4.
Who cannot join
- 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).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Virtual Reality-Based Hand Rehabilitation for Post-Surgical Degenerative Cervical Myelopathy: A Pilot Study
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.
Read the 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
- Being tested
- Virtual Keyboard (VK) System
- Keywords
- degenerative cervical myelopathy, virtual reality, hand dexterity, post-surgical rehabilitation, neurorehabilitation, cervical spine, eeg
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Virtual Keyboard (VK) SystemOther
Participants underwent a 4-week training program comprising 12 one-hour sessions to enhance finger individuation and motor control using a virtual reality platform.
| Study group | Role | What they receive |
|---|---|---|
| Virtual Reality Training Group | Experimental | Participants completed virtual reality-based hand training using the virtual keyboard system. Receives: Other: Virtual Keyboard (VK) System |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline, post-training and follow-up.
Secondary outcomes (10)
Quantitative Electroencephalograms (qEEG)
Beta-band event-related desynchronization (ERD) and cortical coherence are key neural markers often analyzed during finger-tapping tasks to study motor control and cortical connectivity. These measures are often used in clinical studies (e.g., DCM, stroke) to evaluate motor system integrity and changes due to interventions or disease progression.
Measured: Baseline, post-training and follow-up.
Nine-Hole Peg Test (9HPT)
The Nine-Hole Peg Test (9HPT) is a standardized test used to measure finger dexterity. It involves placing and removing pegs from nine holes as quickly as possible. The outcome is recorded as the time taken in seconds, where lower times indicate better dexterity.
Measured: Baseline, post-training and follow-up.
Box and Blocks Test (BBT)
The Box and Blocks Test is a measure of gross manual dexterity. It involves moving as many blocks as possible from one compartment of a box to another in 60 seconds. The score is the total number of blocks moved, where higher scores indicate better manual dexterity.
Measured: Baseline, post-training and follow-up.
QuickDASH
The QuickDASH is a subset of 11 items from the 30-item DASH (Disabilities of the Arm, Shoulder, and Hand) and is a self-reported questionnaire in which the response options are presented as 5-point Likert scales. Lower scores indicate better outcomes.
Measured: Baseline, post-training and follow-up.
Three-point pinch strength
Sensorimotor hand function 3-point pinch strength using a pinch gauge (PG-60, B\&L Engineering) measured in pounds (lbs.).
Measured: Baseline, post-training and follow-up.
Touch sensitivity
Touch sensitivity of the palmar and dorsal hand using von Frey filaments (Aesthesio®), scored out of 12 (12 indicates full sensation)
Measured: Baseline, post-training (1 week after VK training), and 4-week follow-up ( 4 weeks after VK training).
EuroQol 5-Dimension score
The EuroQol 5-Dimension (EQ-5D) is a standardized measure of health-related quality of life. The minimum level sum score (LSS) is derived by summing the responses across the five dimensions (mobility, self-care, usual activities, pain/discomfort, anxiety/depression), each scored from 1 (no problems) to 3 (extreme problems) score is 5, and the maximum score is 15, where higher scores indicate worse health status. It also includes a Visual Analog Scale (VAS) scored from 0 to 100, where higher scores indicate better health.
Measured: Baseline, post-training and follow-up.
Short Form-36 Health Survey version 2
The Short Form-36 Health Survey version 2 (SF-36v2) is a validated, comprehensive measure of health-related quality of life. It includes eight domains (e.g., physical functioning-physical component score (PCS), and mental health-mental component score (MCS)) with scores ranging from 0 to 100, where higher scores indicate better health and functioning. An overall summary score for physical and mental health can also be derived.
Measured: Baseline, post-training and follow-up.
Modified Japanese Orthopedic Association scale
The Modified Japanese Orthopaedic Association (mJOA) Score is a clinical scale used to evaluate the severity of cervical myelopathy. It assesses motor function in the upper and lower extremities, sensation, and bladder function. The total score ranges from 0 to 18, where higher scores indicate better neurological function and less severe disability.
Measured: Baseline, post-training and follow-up.
Myelopathy Disability Index
The Myelopathy Disability Index (MDI) is a validated measure used to assess disability in individuals with cervical myelopathy. It consists of 10 items, each scored from 0 (no disability) to 10 (severe disability). The total score ranges from 0 to 100, where higher scores indicate greater disability.
Measured: Baseline, post-training and follow-up.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Dec 2024
- Study start19 Jul 2023
- Primary completion23 Oct 2024
- Study completion23 Oct 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Degenerative Cervical MyelopathyStudies of the same condition, open and under way.
- More trials run by Medical College of WisconsinThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical College of Wisconsin
- Sponsor type
- University, hospital or other
- Collaborators
- Marquette University, North Carolina State University
- Responsible party
- Principal investigator, Aditya Vedantam, Medical College of Wisconsin
- Investigators
- Aditya Vedantam, MD, Principal investigator, Medical College of Wisconsin
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06754072
- Sponsor's protocol ID
- PRO00044319
- Other IDs
- PI: Vedantam
- Status last verified
- Dec 2024
- First submitted
- 17 Dec 2024
- Last updated
- 31 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: 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.
Publications
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.
PubMed 25542201
Study at a glance
From the registry record, last updated by the sponsor on 31 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Virtual Reality-Based Hand Rehabilitation for Post-Surgical Degenerative Cervical Myelopathy: A Pilot Study
- ClinicalTrials.gov ID
- NCT06754072
- Acronym / sponsor ID
- PRO00044319
- Conditions
- Degenerative Cervical Myelopathy
- Keywords
- degenerative cervical myelopathy, virtual reality, hand dexterity, post-surgical rehabilitation, neurorehabilitation, cervical spine, eeg
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- Medical College of WisconsinUniversity, hospital or other
- Collaborators
- Marquette University, North Carolina State University
- Study start
- 19 Jul 2023 (actual)
- Primary completion
- 23 Oct 2024 (actual)
- Study completion
- 23 Oct 2024 (actual)
- First posted
- 31 Dec 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Virtual Reality Training Group | Experimental | Other: Virtual Keyboard (VK) SystemParticipants completed virtual reality-based hand training using the virtual keyboard system. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Diagnosed with Degenerative Cervical Myelopathy.
- Completed cervical spine surgery within 6 months.
- Modified Japanese Orthopaedic Association (mJOA) upper limb motor score between 1-4.
Key exclusion criteria (4 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Virtual Keyboard (VK) SystemParticipants underwent a 4-week training program comprising 12 one-hour sessions to enhance finger individuation and motor control using a virtual reality platform. | Other | Virtual Reality Training Group |
Primary outcome
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.
10 secondary outcomes
Quantitative Electroencephalograms (qEEG)
Time frame: Baseline, post-training and follow-up.
Nine-Hole Peg Test (9HPT)
Time frame: Baseline, post-training and follow-up.
Box and Blocks Test (BBT)
Time frame: Baseline, post-training and follow-up.
QuickDASH
Time frame: Baseline, post-training and follow-up.
Three-point pinch strength
Time frame: Baseline, post-training and follow-up.
Touch sensitivity
Time frame: Baseline, post-training (1 week after VK training), and 4-week follow-up ( 4 weeks after VK training).
EuroQol 5-Dimension score
Time frame: Baseline, post-training and follow-up.
Short Form-36 Health Survey version 2
Time frame: Baseline, post-training and follow-up.
Modified Japanese Orthopedic Association scale
Time frame: Baseline, post-training and follow-up.
Myelopathy Disability Index
Time frame: Baseline, post-training and follow-up.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Dec 2024.
- Background: PubMed 25542201Thielbar 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.
- Individual participant dataSharing planned: No. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Aditya Vedantam, MD principal investigator
Medical College of Wisconsin
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Virtual Keyboard (VK) System in people with Degenerative Cervical Myelopathy, run by Medical College of Wisconsin at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 31 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Jebsen-Taylor Hand Function Test (time frame: Baseline, post-training and follow-up.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06754072, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Dec 2024.