NCT06407089

Brief Summary

The aim of this study is to compare the effects of a 12-session telerehabilitation program based on Specific Neck Exercises (SNE) with Spinertial to a control group on range of motion, cervical proprioception, and posture in subjects with forward head posture, post-intervention, after one month of follow-up, and after two months of follow-up.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
52

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started May 2024

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 6, 2024

Completed
3 days until next milestone

First Posted

Study publicly available on registry

May 9, 2024

Completed
11 days until next milestone

Study Start

First participant enrolled

May 20, 2024

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 20, 2024

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 20, 2024

Completed
Last Updated

March 17, 2025

Status Verified

May 1, 2024

Enrollment Period

4 months

First QC Date

May 6, 2024

Last Update Submit

March 12, 2025

Conditions

Keywords

telerrehabilitationdeep cervical musclesneck musclesexercise therapyspecific neck exercises

Outcome Measures

Primary Outcomes (3)

  • Mean Change in Craniovertebral angle (CVA) from baseline

    The examiners assess the cranio-vertebral angle (CVA), reflecting the forward head posture position, is the acute anglecreated between the horizontal plane and the line from the tip of the C7 spinous process to the tragion. Head postureis measure as the acute angle between the horizontal plane and the line from the corner of the eye to the tragion(ETH).

    Baseline and 6 weeks, 10 weeks, 14 weeks

  • Mean Change in Cervical Spine Range of Motion (ROM) from Baseline.

    Mean change from baseline in Lower and Upper Cervical Spine Range of Movement (ROM) in the sagittal, frontal and transverse planes after 6 weeks, 10 weeks, and 14 weeks. The examiners assess cervical ROM using CROM (Cervical Range-of-Motion Instrument). Cervical flexion, extension, right/left side bending, and right/left rotation will be evaluated in the sagittal, frontal, and transverse planes. The examiners assess cervical ROM using CROM (Cervical Range-of-Motion Instrument). Upper cervical flexion, upper cervical extension, and flexion rotation test will be evaluated in the frontal and transverse planes. The flexion rotation test is used to assess the movement of the upper cervical spine and is the most commonly used test in the literature. It is considered positive when there is a decrease of 10 degrees or more in cervical rotation with maximum flexion, in comparison to the contralateral side, or when there is hypomobility of segment C1 with mobility less than 32.

    Baseline and 6 weeks, 10 weeks, 14 weeks

  • Mean Change in Joint Position error from baseline

    Joint Position Error (JPE): The examiners assess the subject's ability (while blindfolded) to relocate the natural head posture (NHP) following the movements of left and right rotation, flexion and extension, upper flexion and upper extension. The relocation error (joint position error, JPE) is the difference between the starting position and the NHP after movement.

    Baseline and 6 weeks, 10 weeks, 14 weeks

Study Arms (2)

Spinertial Group (SG)

EXPERIMENTAL

Endurance training program of deep cervical flexors and deep cervical extensors with Spinertial device for treatment. Endurance training program of deep cervical flexors and deep cervical flexors with Spinertial device for treatment.

Other: Spinertial Group

Control Group (CG)

NO INTERVENTION

The subject continues activities of daily living without intervention.

Interventions

Endurance training program of deep cervical flexors and deep cervical extensors with Spinertial device for treatment. Endurance training program of deep cervical flexors and deep cervical flexors with Spinertial device for treatment.

Spinertial Group (SG)

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Forward head posture (craniovertebral angle less than 50º).
  • Deep flexor strength deficit in craniocervical flexion test.
  • Deep extensor strength deficit in neck extensor muscle endurance.
  • ≤ 14 score in Neck Disability Index.

You may not qualify if:

  • Have received cervical treatment during the last six months.
  • Presence of any red flag, neurological, or cognitive impairment (inability to - - understand the questionnaires or examination).
  • Have received cervical manual therapy treatment during the last six months.
  • History of cervical trauma or surgery during the last year.
  • Chronic neck pain occurring during the last six months (intensity: visual analogue scale \>3/10, frequency \>2 days/week, duration \>3 hours/day).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Élite Fisioterapia, María Montessori 2.

Zaragoza, Zaragoza, 50018, Spain

Location

MeSH Terms

Conditions

Neck Pain

Condition Hierarchy (Ancestors)

PainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Pilar Pardos-Aguilella

    Universidad de Zaragoza

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Doctor of Physical Therapy

Study Record Dates

First Submitted

May 6, 2024

First Posted

May 9, 2024

Study Start

May 20, 2024

Primary Completion

September 20, 2024

Study Completion

November 20, 2024

Last Updated

March 17, 2025

Record last verified: 2024-05

Data Sharing

IPD Sharing
Will not share

Locations