NCT05331482

Brief Summary

The purpose of this study is to evaluate the clinical results in lower cervical range of motion, size deep muscles, endurance, craniovertebral angle and cervical propioception by a training protocol with the new device for cervical treatment (CDAT) and the conventional training protocol (CT) versus a control group (C) in subjects with cervical deep muscle strength deficit.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
105

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Apr 2022

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

April 10, 2022

Completed
1 day until next milestone

Study Start

First participant enrolled

April 11, 2022

Completed
4 days until next milestone

First Posted

Study publicly available on registry

April 15, 2022

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2022

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2022

Completed
Last Updated

August 24, 2025

Status Verified

August 1, 2023

Enrollment Period

6 months

First QC Date

April 10, 2022

Last Update Submit

August 18, 2025

Conditions

Keywords

neck musclesneck painexercise therapytelerehabilitationmuscle weakness

Outcome Measures

Primary Outcomes (4)

  • Deep neck flexor endurance Test.

    The Chin Tuck Neck Flexion Test is an assessment technique intended to determine the endurance of the deep cervical flexors.

    Baseline and 6 weeks, 10 weeks, 14 weeks

  • Neck extensor muscle endurance Test

    Mean change from baseline in neck extensor muscle endurance Test after 6 weeks, 10 weeks and 14 weeks. The examiners assess the endurance of deep cervical extensor muscle.

    Baseline and 6 weeks, 10 weeks, 14 weeks

  • Measurement of Cervical Multifidus and Longus Colli Muscle size.

    The examiners assess these deep muscles with ultrasound after 6 weeks, 10 weeks and 14 weeks.

    Baseline and 6 weeks, 10 weeks, 14 weeks

  • Physical activity enjoyment Scale (PACES)

    The examiners assess participant satisfaction with cervical deep muscle training. This scale measures enjoyment during physical activity through 16 items, which are preceded by the phrase "When I am active..." This instrument measures enjoyment and bipolar enjoyment, through statements such as "I enjoy it", "I'm bored", "It's very exciting", and "I don't like it". The answers will be collected on a Likert scale from 1 (totally disagree) to 5 (totally agree).

    6 weeks

Secondary Outcomes (2)

  • Neck Disability Index

    Baseline and 6 weeks, 10 weeks, 14 weeks

  • Neck Pain

    Baseline and 6 weeks, 10 weeks, 14 weeks

Study Arms (3)

Training protocol with the cervical device for treatment (CDAT).

EXPERIMENTAL

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

Other: Training protocol with the cervical device for treatment (CDAT).

Conventional training protocol-

ACTIVE COMPARATOR

Endurance training program of deep cervical flexors and deep cervical extensors with the conventional protocol.

Other: Conventional training protocol

Control Group

NO INTERVENTION

Subject continues with activities of daily living. Does not receive deep cervical muscle training.

Interventions

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

Training protocol with the cervical device for treatment (CDAT).

Endurance training program of deep cervical flexors and deep cervical extensors with conventional training protocol.

Conventional training protocol-

Eligibility Criteria

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

You may qualify if:

  • 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 month, presented any red flag, neurological or cognitive impairment (inability to understand the questionnaires or examination).
  • Have received cervical manual therapy treatment during the last six month.
  • A 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 PainMuscle Weakness

Interventions

Therapeutics

Condition Hierarchy (Ancestors)

PainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsMuscular DiseasesMusculoskeletal DiseasesNeuromuscular ManifestationsNervous System DiseasesPathologic Processes

Study Officials

  • Pilar Pardos-Aguilella

    UicCatalunya

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: This will be a randomized controlled trial with 3 different groups
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Colaborator Lecturer in Physiotherapy

Study Record Dates

First Submitted

April 10, 2022

First Posted

April 15, 2022

Study Start

April 11, 2022

Primary Completion

October 1, 2022

Study Completion

December 1, 2022

Last Updated

August 24, 2025

Record last verified: 2023-08

Data Sharing

IPD Sharing
Will not share

Locations