Forward Head PostureNCT04743427
EFFECTS OF BODY-BLADE EXERCISES ON NECK POSTURE, FUNCTION, AND MUSCLE STRENGTH IN FORWARD HEAD POSTURE
A study testing hot pack and exercises and body blade(BB) in people with Forward Head Posture, run by Cairo University at 1 site in Egypt.
Trial summary
This study will be conducted to determine the effect of adding Body-blade exercises to traditional treatment on posture, scapular muscles strength, neck pain, and function in individuals with forward head posture Read more about this study
- Who is it for?
- Ages 20 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Forward Head Posture
- What is being tested?
- hot pack and exercises and body blade(BB)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 42 participants
- Where
- 1 siteEgypt
- Study dates
- 30 Dec 2020to Aug 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Participants with FHP of both genders
- Age range from 20-40 years
- craniovertebral angle (CVA) less than 52 degrees
Who cannot join
- Patients with a previous diagnosis of a musculoskeletal system disease over the last 6 months,
- severely unstable spine
- osteoporosis
- vascular disease
- cervical or shoulder neurological movement disorder
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Mansheyet El Bakry General Hospital
Cairo
enas fawzy, +201127867507, Enas.fawzy@pt.cu.edu.eg
About this study
This study will be conducted to determine the effect of adding Body-blade exercises to traditional treatment on posture, scapular muscles strength, neck pain, and function in individuals with forward head posture
Read the detailed description
Many studies have proposed that the Body-blade may be a more effective tool for activating the muscles employed during the training and rehabilitation of the shoulder and trunk than traditional interventions such as cuff weights and Therabands. There is few literature which studied the effect of Body-blade exercises on neck problems. So there is insufficient evidence for their effectiveness on improving forward head posture.
- Conditions
- Forward Head Posture
- Being tested
- hot pack and exercises, body blade(BB)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
hot pack and exercisesOther
20-minute hot pack,and three active exercises: (a) chin tucks in supine lying with the head in contact with the floor, (b) active Standing Shoulder pull back , and (c) scapular plane shoulder elevation. (3 sets of 10 repetitions for all the 3 exercises)
body blade(BB)Device
The Body-blade (Classic, Mad Dogg Athletics, USA), an elastic pole exercise tool with 122 cm in length, 0.68 kg, 4.3 cm in width,based on oscillatory/vibration motions that have been used in training or rehabilitation.The body blade works by rapidly changing directions at a low-frequency rhythm of approximately 4.5 Hz (cycles per second )
| Study group | Role | What they receive |
|---|---|---|
| physical therapy inervention | Experimental | 1. hot pack
2. Three active exercises Receives: Other: hot pack and exercises |
| Body-blade exercises in addition to physical therapy intervention | Experimental | 1. Three Body-blade exercises will be performed in random order (Two sets of, 3-minute exercise and 5-minute break, for each exercise )
2. hot pack
3. Three active exercises Receives: Other: hot pack and exercises; Device: body blade(BB) |
What is being measured
The primary outcome is the main question the study is designed to answer.
cranio vertebral angle using the Autocad
It is defined as the angle formed from a horizontal line passing through the C7 spinous process and a line passing through the tragus of the ear
Measured: 5 minutes
Secondary outcomes (3)
pain using visual Analogue Scale (VAS)
VAS is a self-reported scale consisting of a horizontal or vertical line, usually 10 centimeters long (100 mm) anchored at the extremes by two verbal descriptors referring to the pain status
Measured: 5 minutes
Neck function using the Neck Disability Index
The participants will be informed with the questionnaire10-items: pain intensity, personal care, lifting, work, headaches, concentration, sleeping, driving, reading, and recreation. and will be asked to fill the response to each item which is rated on a 6-point scale from 0 (no disability) to 5 (complete disability).The higher the final score the more severe the functional disability. Scores were divided into 0- 4 points for no disability, 5-14 points for mild disability, 15-24 points for moderate disability, 25-34 points for severe disability, and 35 or higher for complete disability
Measured: 5 minutes
Scapular muscles strength using Hand Held Dynamometer
the participants will be positioned in different positions according to the muscle to be measured .
Measured: 10 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Feb 2021
- Study start30 Dec 2020
- Primary completionApr 2021 (estimated)
- Study completionAug 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Forward Head PostureStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Double-Blinded Randomized Controlled Trial (one investigator to make the assessment,and another investigator for application of the treatment procedures)
- Masking
- Double blind
- Who is masked
- Care provider, Investigator
- Enrolment
- 42 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nourhan Ahmed Gamal Eldin Sarhan, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04743427
- Sponsor's protocol ID
- Forward head posture treatment
- Status last verified
- Jan 2021
- First submitted
- 3 Feb 2021
- Last updated
- 8 Feb 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Sheikhhoseini R, Shahrbanian S, Sayyadi P, O'Sullivan K. Effectiveness of Therapeutic Exercise on Forward Head Posture: A Systematic Review and Meta-analysis. J Manipulative Physiol Ther. 2018 Jul-Aug;41(6):530-539. doi: 10.1016/j.jmpt.2018.02.002. Epub 2018 Aug 11.
PubMed 30107937Lister JL, Del Rossi G, Ma F, Stoutenberg M, Adams JB, Tobkin S, Signorile JF. Scapular stabilizer activity during Bodyblade, cuff weights, and Thera-Band use. J Sport Rehabil. 2007 Feb;16(1):50-67. doi: 10.1123/jsr.16.1.50.
PubMed 17699887
Study at a glance
From the registry record, last updated by the sponsor on 8 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- EFFECTS OF BODY-BLADE EXERCISES ON NECK POSTURE, FUNCTION, AND MUSCLE STRENGTH IN FORWARD HEAD POSTURE
- ClinicalTrials.gov ID
- NCT04743427
- Acronym / sponsor ID
- Forward head posture treatment
- Conditions
- Forward Head Posture
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 42 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 30 Dec 2020 (actual)
- Primary completion
- Apr 2021 (estimated)
- Study completion
- Aug 2021 (estimated)
- First posted
- 8 Feb 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study will be conducted to determine the effect of adding Body-blade exercises to traditional treatment on posture, scapular muscles strength, neck pain, and function in individuals with forward head posture
Detailed description
Many studies have proposed that the Body-blade may be a more effective tool for activating the muscles employed during the training and rehabilitation of the shoulder and trunk than traditional interventions such as cuff weights and Therabands. There is few literature which studied the effect of Body-blade exercises on neck problems. So there is insufficient evidence for their effectiveness on improving forward head posture.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (care provider, investigator)
- Number of arms
- 2
- Model description
- Double-Blinded Randomized Controlled Trial (one investigator to make the assessment,and another investigator for application of the treatment procedures)
| Arm | Type | Receives |
|---|---|---|
| physical therapy inervention | Experimental | Other: hot pack and exercises1. hot pack 2. Three active exercises |
| Body-blade exercises in addition to physical therapy intervention | Experimental | Other: hot pack and exercises, Device: body blade(BB)1. Three Body-blade exercises will be performed in random order (Two sets of, 3-minute exercise and 5-minute break, for each exercise ) 2. hot pack 3. Three active exercises |
Who may qualify
- Ages
- 20 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Participants with FHP of both genders
- Age range from 20-40 years
- craniovertebral angle (CVA) less than 52 degrees
Key exclusion criteria (5 listed)
- Patients with a previous diagnosis of a musculoskeletal system disease over the last 6 months,
- severely unstable spine
- osteoporosis
- vascular disease
- cervical or shoulder neurological movement disorder
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| hot pack and exercises20-minute hot pack,and three active exercises: (a) chin tucks in supine lying with the head in contact with the floor, (b) active Standing Shoulder pull back , and (c) scapular plane shoulder elevation. (3 sets of 10 repetitions for all the 3 exercises) | Other | Body-blade exercises in addition to physical therapy intervention, physical therapy inervention |
| body blade(BB)The Body-blade (Classic, Mad Dogg Athletics, USA), an elastic pole exercise tool with 122 cm in length, 0.68 kg, 4.3 cm in width,based on oscillatory/vibration motions that have been used in training or rehabilitation.The body blade works by rapidly changing directions at a low-frequency rhythm of approximately 4.5 Hz (cycles per second ) | Device | Body-blade exercises in addition to physical therapy intervention |
Primary outcome
cranio vertebral angle using the Autocad
Time frame: 5 minutes
It is defined as the angle formed from a horizontal line passing through the C7 spinous process and a line passing through the tragus of the ear
3 secondary outcomes
pain using visual Analogue Scale (VAS)
Time frame: 5 minutes
Neck function using the Neck Disability Index
Time frame: 5 minutes
Scapular muscles strength using Hand Held Dynamometer
Time frame: 10 minutes
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Feb 2021.
- Background: PubMed 30107937Sheikhhoseini R, Shahrbanian S, Sayyadi P, O'Sullivan K. Effectiveness of Therapeutic Exercise on Forward Head Posture: A Systematic Review and Meta-analysis. J Manipulative Physiol Ther. 2018 Jul-Aug;41(6):530-539. doi: 10.1016/j.jmpt.2018.02.002. Epub 2018 Aug 11.
- Background: PubMed 17699887Lister JL, Del Rossi G, Ma F, Stoutenberg M, Adams JB, Tobkin S, Signorile JF. Scapular stabilizer activity during Bodyblade, cuff weights, and Thera-Band use. J Sport Rehabil. 2007 Feb;16(1):50-67. doi: 10.1123/jsr.16.1.50.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing hot pack and exercises and body blade(BB) in people with Forward Head Posture, run by Cairo University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 8 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Nourhan Sarhan, bachelor (+201060551785/+201151928893, nourhan_theworld@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
cranio vertebral angle using the Autocad (time frame: 5 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04743427, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Feb 2021.