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

NCT07418632 | Recruiting

• 1 other identifier: 0120-48/2023/8
• Study Type: interventional
• Target: 38
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Chronic Neck Pain

Outcome Measures

Primary Outcomes (2)

• 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.

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

• 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

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

Secondary Outcomes (6)

• Precision time (in movement control test)

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

• Underreaching (in movement control test)

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

• Overreaching (movement control test)

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

• Jerk index (in movement control test)

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

• Absolute error (in head-to-neutral relocation test)

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

Other Outcomes (1)

• 16 VSP (16 item visual symptoms proforma)

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

Study Arms (5)

Patietns with smallest movement deficits

EXPERIMENTAL

A group that in kinematic movement assessment presents with most time and closest to the target, with lowest overeaching and low unereaching. This group presents with mild to moderate pain levels. Kinematic training intervention (head and neck movement training): focused on head and neck movement training in a sitting position with changing velocities, amplitudes and changes of direction without specific range of motion limits. The listed parameters are increased when the average session accuracy reaches 60% time-on-target. Patients will perform 4 training sessions per week (20 min duration each), for four weeks.

Other: Smallest movement deficit training protocol

Patients with smaller movement deficits

EXPERIMENTAL

This group stays considerable amount of time and close to the target, has high underreaching at medium and difficult level and smallest overreaching at all difficulty levels; presents with mild to moderate pain levels. Kinematic training intervention (head and neck movement training): focused on head and neck movement training in a sitting position with randomly changing velocities, in a predefined movement directions. The listed parameters are increased when the average session accuracy reaches 60% time-on-target. When 60% time-on-target is reached at the difficult level, random moveemnt directions are introduced. Patients will perform 4 training sessions per week (20 min duration each), for four weeks.

Other: Smaller movement deficit training protocol

Patients with lerger movement deficits

EXPERIMENTAL

This gorup stays less time and further away from the target, with high underreaching, most prominent feature is high overreaching; presents with mild to moderate pain levels. Kinematic training intervention (head and neck movement training): focused on head and neck movement training in a sitting position with constant velocities, amplitudes with no changes of direction and with range of motion limits relative to the pain onset. The listed parameters are increased when the average session accuracy reaches 60% time-on-target. Patients will perform 4 training sessions per week (20 min duration each), for four weeks.

Other: Larger movement deficit training group

Patients with largest movement deficits

EXPERIMENTAL

This gorup stays least time and furthest away from the target, with highest undershoot (all difficulty levels, with significantly affected performance already at easy level) and overshoot; presents with moderate to severe pain levels

Other: Largest movement deficit training protocol

Control group of patinets with neck pain

ACTIVE COMPARATOR

Group of patients with neck pain consisting equally from all four cluster groups.

Other: Control group intervention protocol

Interventions

Smallest movement deficit training protocol OTHER

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.

Patietns with smallest movement deficits

Smaller movement deficit training protocol OTHER

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.

Patients with smaller movement deficits

Larger movement deficit training group OTHER

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.

Patients with lerger movement deficits

Largest movement deficit training protocol OTHER

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.

Patients with largest movement deficits

Control group intervention protocol OTHER

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.

Control group of patinets with neck pain

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• presence of neck pain
• pain level minimum 3 of 10 on VAS
• did not receive conventional physiotherapy in last 6 months

You may not qualify if:

• any upper extremity pain within last 2 years
• any neurological or vestibular dissorders
• type 2 diabetes
• diagnosed psychiatric dissorders
• medication or alcohol consumptin in last 30 hours

Sponsors & Collaborators

• University of Ljubljana: lead

Study Sites (1)

Faculty of Sport

Ljubljana, 1000, Slovenia

RECRUITING

Central Study Contacts

Ziva Majcen rosker, PhD, PT

CONTACT

00386 51267383; ziva.majcen-rosker@fsp.uni-lj.si

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: assist. prof. Ziva Majcen Rosker, PT, PhD

Study Record Dates

• First Submitted: August 10, 2025
• First Posted: February 18, 2026
• Study Start: March 18, 2026
• Primary Completion (Estimated): June 20, 2026
• Study Completion (Estimated): September 20, 2026
• Last Updated: February 18, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

SL (1)