Effectiveness of Two Exercise Programs on the Neck.
1 other identifier
interventional
105
1 country
1
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
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Apr 2022
Shorter than P25 for not_applicable
1 active site
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
CompletedStudy Start
First participant enrolled
April 11, 2022
CompletedFirst Posted
Study publicly available on registry
April 15, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2022
CompletedAugust 24, 2025
August 1, 2023
6 months
April 10, 2022
August 18, 2025
Conditions
Keywords
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).
EXPERIMENTALEndurance training program of deep cervical flexors and deep cervical extensors with the cervical device for treatment.
Conventional training protocol-
ACTIVE COMPARATOREndurance training program of deep cervical flexors and deep cervical extensors with the conventional protocol.
Control Group
NO INTERVENTIONSubject 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.
Endurance training program of deep cervical flexors and deep cervical extensors with conventional training protocol.
Eligibility Criteria
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
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Pilar Pardos-Aguilella
UicCatalunya
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- 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