NCT05533853

Brief Summary

The goal of the study is to compare various methods of correcting forward head posture in elderly subjects. In particular, we will contrast two methods: the conventional program, which aims to restore muscle balance, and the Chiropractic BioPhysics (CBP) rehabilitation program, which relies on stretching the viscous and plastic elements of the longitudinal ligament and intervertebral disc in addition to effectively stretching the soft tissue throughout the entire body.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
80

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Sep 2022

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 5, 2022

Completed
4 days until next milestone

First Posted

Study publicly available on registry

September 9, 2022

Completed
1 day until next milestone

Study Start

First participant enrolled

September 10, 2022

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 30, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 30, 2022

Completed
Last Updated

September 9, 2022

Status Verified

September 1, 2022

Enrollment Period

2 months

First QC Date

September 5, 2022

Last Update Submit

September 5, 2022

Conditions

Keywords

Forward head postureElderlyRandomized controlled trial

Outcome Measures

Primary Outcomes (1)

  • The change in craniovertebral angle

    The craniovertebral angle will be measured by taking a lateral photograph. The participants will be asked to sit on a chair as usual and a lateral photograph will be taken. Adhesive markers will be fixed on the tragus of the ear and the spinous processes of the seventh cervical vertebra. The head forward angle will be measured as an angle between a line drawn from the tragus of the ear to the seventh cervical vertebra and horizontal line

    will be measured at two intervals ;pre-treatment and immediately after treatment

Secondary Outcomes (3)

  • The change in pain intensity

    will be measured at two intervals ;pre-treatment and immediately after treatment

  • The change in Neck Disability Index

    will be measured at two intervals ;pre-treatment and immediately after treatment

  • Changes in Cervical joint position sense testing

    will be measured at two intervals ;pre-treatment and immediately after treatment

Study Arms (2)

Traditional exercise

ACTIVE COMPARATOR

The exercise group will receive a posture corrective exercise program in the form of two strengthening(deep cervical flexors and shoulder retractors)and two stretching (cervical extensors and pectoral muscles) exercises. The exercise program will be done according to Harman et al.'s protocol and based on Kendall et al.'s approach.

Other: Posture corrective exercises

Denneroll extension traction

EXPERIMENTAL

Denneroll extension traction. Participants in the intervention group will receive the Denneroll cervical orthotic . In the current study, Denneroll cervical traction will be used to restore the normal cervical alignment. . We will follow previously published protocols and procedures for application of this orthotic. The Denneroll orthotic will be performed in the physiotherapy clinic setting. The participants will be instructed to lie supine on the floor, in a straightened position, with their arms gently folded across their stomach.

Other: Denneroll extension traction

Interventions

The exercises are of two types strengthening exercises and starching exercise ,). The strengthening exercises are to be done for 15 repetitions in 2 sets, Progression will be by increasing to 3 sets and adding 1 Kilogram of resistance in dumbbells exercises, the targeted muscles are teres minor, infraspinatus, medial and lower trapezius, rhomboids, and cervical flexor muscles. On the other hand, stretching exercises are to be hold for 30 seconds for 2 sets then progressed to 3 sets, the targeted muscles are pectoralis minor, sternocleidomastoid and levator scapulae.

Traditional exercise

The participants will be instructed to lie supine and keep their legs extended. Based on the apex of each participant's cervical curvature on the initial radiograph, the therapist will position the apex of the denneroll in one of two regions (mid cervical placement or lower cervical placement). The duration of the traction session will start at 2-3 min and increased 1 min per session until reaching the goal of 20 min, the traction will repeated three times per week for 6 weeks

Denneroll extension traction

Eligibility Criteria

Age60 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • craniovertebral angle (CVA) is less than 50°

You may not qualify if:

  • any signs or symptoms of medical "red flags" were present: tumor, fracture, rheumatoid arthritis, severe osteoporosis, and prolonged steroid use.
  • Subjects with previous spine surgery
  • Neurological diseases
  • Vascular disorders

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ibrahim Moustafa

Sharjah city, United Arab Emirate, 27272, United Arab Emirates

Location

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
The treating therapist, for both the control and intervention groups, was unblinded to the treatment method but the assessor who conducted the measurements were blinded. Assessor blinding was obtained through an independent research assist; not knowing the study design and not specifically involved in any aspect of the trial
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: A prospective, double blinded, parallel-group, randomized clinical trial was conducted at one of our university's research departments,
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor-chair of Physiotherapy Department

Study Record Dates

First Submitted

September 5, 2022

First Posted

September 9, 2022

Study Start

September 10, 2022

Primary Completion

October 30, 2022

Study Completion

October 30, 2022

Last Updated

September 9, 2022

Record last verified: 2022-09

Data Sharing

IPD Sharing
Will not share

Locations