Kinematic Training in Patients With Neck Pain Based on Machine Learning Classification Approach

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-65
SponsorUniversity of Ljubljana

About this trial

The goal of this clinical trial is to study if kinematic training based on novel kinematic assessment clasification approach can decrease chronic neck pain and prevent its reoccurance better than conventional kinematic training in adults. The main question\[s\] it aims to answer \[is/are\]:

Does clustering patients with neck pain based on head and neck movement characteristics lead to more efficient kinematic rehabilitation training and improved clinical outcomes

Researchers will compare effects of cluster specific kinematic training to see if it effects pain levels and its reoccurance.

Participants will \[describe the main tasks participants will be asked to do, interventions they'll be given and use bullets if it is more than 2 items\].

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

presence of neck pain

pain level minimum 3 of 10 on VAS

did not receive conventional physiotherapy in last 6 months

Disqualifiers

any upper extremity pain within last 2 years

any neurological or vestibular dissorders

type 2 diabetes

diagnosed psychiatric dissorders

Trial design

Design model

Parallel

Treatments tested in this trial

  • Smallest movement deficit training protocol

    Other intervention

    Kinematic training intervention (head and neck movement training): focused on head and neck movement training in a sitting position with changing velocities (ranges of difficulty levels from 0,5 to 3, 3 to 5, and 4 to 7 deg/s), amplitudes (40 to 90% ROM), and changes of direction/movements (combination of single and mixed axis of movement - flexion/extension and lef or right rotations). The listed parameters are increased when the average accuracy of two following training sessions reaches 60% time-on-target. Patients will perform 4 training sessions per week (20 min duration each), for four weeks.

  • Smaller movement deficit training protocol

    Other intervention

    Kinematic training intervention (head and neck movement training): focused on head and neck movement training in a sitting position with the task to catch the moving target (always starting 2-15 deg in front of the starting position of the head) moving at different constant velocities (ranges of individual trial velocities at different difficulty levels - 0,5 to 3, 3 to 5, and 4 to 7 deg/s), amplitudes (40 to 90% ROM). Movements will be perfromed in a diagonal 2D line encompasing flexion/extension and rotations). The listed parameters are increased when the average session accuracy reaches 60% time-on-target. If 60% time-on-target will be reached before the end of 4 week training period, general training intervention will be continued. Patients will perform 4 training sessions per week (20 min duration each), for four weeks.

  • Larger movement deficit training group

    Other intervention

    Kinematic training intervention (head and neck movement training): focused on head and neck movement training in a sitting position with the task to follow the moving target (always starting at the same starting position of the head) moving at different constant velocities (ranges of individual trial velocities at different difficulty levels - 0,5 to 3, 3 to 5, and 4 to 7 deg/s), amplitudes (40 to 90% ROM). All movements finish at random point which has to be maintained for 5 s. Movements will be performed in diagonal 2D lines simultaneously encompasing flexion/extension and rotations). The listed parameters are increased when the average session accuracy reaches 60% time-on-target. If 60% time-on-target will be reached before the end of 4 week training period, training intervention of the group with smaller movement deficits will be continued. Patients will perform 4 training sessions per week (20 min duration each), for four weeks.

  • Largest movement deficit training protocol

    Other intervention

    Kinematic training intervention (head and neck movement training): focused on head and neck movement training in a sitting position with the goal to follow the moving target (always starting at the same starting position as the head) moving at different constant velocities (ranges of individual trial velocities at different difficulty levels - 0,5 to 3, 3 to 5, and 4 to 7 deg/s), amplitudes (40 to 90% ROM). All movements finish at random point which has to be maintained for 5 s. Movements will be performed in a single axis (flexion/extension and seperatelly rotations). The listed parameters are increased when the average session accuracy reaches 60% time-on-target. If 60% time-on-target will be reached before the end of 4 week training period, training intervention of the group with larger movement deficits will be continued. Patients will perform 4 training sessions per week (20 min duration each), for four weeks.

  • Control group intervention protocol

    Other intervention

    Kinematic training intervention (head and neck movement training): focused on head and neck movement training in a sitting position with constant velocities (ranges of difficulty levels from 0,5 to 3, 3 to 5, and 4 to 7 deg/s), at different amplitudes between trials (40 to 90% ROM), and at predefined movement paths (square, circle, zig-zag and figure of 8 pattern). The listed parameters are increased when the average accuracy of two following training sessions reaches 60% time-on-target. Patients will perform 4 training sessions per week (20 min duration each), for four weeks.

Treatment groups

38 Participants
are divided into 5 treatment groups
Group A: Patietns with smallest movement deficitsExperimental treatment 1 intervention
Group B: Patients with smaller movement deficitsExperimental treatment 1 intervention
Group C: Patients with lerger movement deficitsExperimental treatment 1 intervention
Group D: Patients with largest movement deficitsExperimental treatment 1 intervention
Group E: Control group of patinets with neck painActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Vas score (Visual analogue scale - pain intensity level)

The Visual Analogue Scale (VAS) is a patient-reported measure of pain intensity. Participants rate their current neck pain on a 10-cm horizontal line anchored by: * 0 = no pain (best outcome) * 10 = worst imaginable pain (worst outcome) The score is determined by measuring the distance (in centimeters or millimeters) from the "no pain" anchor to the participant's mark. Total scores therefore range from 0 to 10 (or 0-100 mm), with higher scores indicating greater pain intensity. A decrease in VAS score over time indicates improvement, while an increase indicates worsening pain. For responder analyses, a clinically meaningful improvement is defined as a reduction of at least 2 points (or 20 mm) from baseline.

Time frame
Start of the study, after 4 week training period and after 3 months follow up period
2

NDI score

The Neck Disability Index is a patient-reported questionnaire assessing how neck pain affects daily activities. It includes 10 items (pain intensity, personal care, lifting, reading, headaches, concentration, work, driving, sleeping, and recreation). Each item is scored from 0 to 5, where: * 0 indicates no pain or no functional limitation (best outcome) * 5 indicates maximum pain or complete functional limitation (worst outcome) The total score ranges from 0 to 50, with: * 0 = no neck-related disability (best possible score) * 50 = maximum disability (worst possible score) For reporting purposes, the total score may also be expressed as a percentage from 0% (no disability) to 100% (complete disability). A decrease in score over time indicates improvement, while an increase indicates worsening disability. For analyses using a responder threshold, participants are considered to have achieved a clinically meaningful improvement if their total NDI score decreases by at least 5 points (on

Time frame
Start of the study, after 4 week training period and after 3 months follow up period

Secondary outcomes

1

Precision time (in movement control test)

Precision Time is an objective outcome derived from the cervical movement control tests, a computerized cervical movement control task. Participants control a visual cursor using head or neck movements and are instructed to keep the cursor aligned with a moving or stationary on-screen target. Precision Time is expressed as the percentage of total trial time during which the cursor remains within a predefined target zone. Scores range from 0% (cursor never within the target; worst performance) to 100% (cursor within the target for the entire trial; best performance). Higher Precision Time values indicate better cervical sensorimotor control and movement accuracy. An increase in Precision Time across assessments reflects improvement.

Time frame
At start, after 4 week intervention and at 3 month follow-up period.
2

Underreaching (in movement control test)

Underreaching (undershoot) is an objective performance metric derived from a computerized cervical movement control test. During the test, participants use head or neck movements to guide a visual cursor toward a target displayed on a screen. Underreaching represents the percentage of total trial time during which the cursor remains short of the target zone (i.e., does not reach the required amplitude or position). Scores range from 0% (no undershoot; best performance) to 100% (cursor consistently fails to reach the target; worst performance). Higher underreaching values indicate reduced movement amplitude control and impaired cervical sensorimotor accuracy. A decrease in underreaching across repeated assessments reflects improvement.

Time frame
At start, after 4 week intervention and at 3 month follow-up period.
3

Overreaching (movement control test)

Overshoot (overreaching) is an objective performance metric derived from a computerized cervical movement control test. During the test, participants use head or neck movements to guide a visual cursor toward a target displayed on a screen. Overshoot represents the percentage of total trial time during which the cursor exceeds the predefined target zone (i.e., moves beyond the required amplitude or position). Scores range from 0% (no overshoot; best performance) to 100% (cursor consistently exceeds the target zone; worst performance). Higher overshoot values indicate reduced movement precision and impaired control of movement amplitude. A decrease in overshoot across repeated assessments reflects improvement.

Time frame
At start, after 4 week intervention and at 3 month follow-up period.
4

Jerk index (in movement control test)

Jerk Index is an objective kinematic performance metric derived from a computerized cervical movement control test. During the test, participants use head or neck movements to guide a visual cursor toward a target displayed on a screen. The Jerk Index quantifies movement smoothness by calculating the rate of change of acceleration (jerk) across the movement trajectory, normalized to trial duration and amplitude. Higher values reflect less smooth, more abrupt or irregular movements, whereas lower values indicate smoother and more controlled motion. Scores range from 0 (perfectly smooth movement; best performance) upward, with no fixed upper limit; higher scores represent poorer movement control (worse performance). A decrease in Jerk Index across repeated assessments indicates improvement in cervical motor control.

Time frame
At start, after 4 week intervention and at 3 month follow-up period.

Other outcomes

1

16 VSP (16 item visual symptoms proforma)

Visual Disturbances - 16-Item Proforma Subjective visual disturbances will be assessed using a 16-item proforma designed to evaluate visual symptoms commonly reported in individuals with neck pain. The items include: blurred vision, words or objects moving on the page, need to concentrate to read, difficulty judging distance, heavy eyes, sore eyes, red eyes, eye strain, visual fatigue, itchy eyes, squinting, difficulty focusing on close work, double vision, spots before the eyes, sensitivity to light, and dizziness when reading. For each symptom, participants rate: * Intensity on a 3-point scale (1 = mild, 2 = moderate, 3 = severe) * Frequency on a 4-point scale (1 = rare, 2 = occasional, 3 = frequent, 4 = always) If a symptom is absent, it is scored as 0 (not present). Higher scores indicate greater severity and/or frequency of visual disturbance.

Time frame
At start, after 4 week intervention and at 3 month follow-up period.

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