The Acute Effect of Proprioceptive Neuromuscular Facilitation on Cervical Range of Motion, Strength and Proprioception. (RCT)

August 26, 2019 updated by: Yeditepe University

The Acute Effect of Proprioceptive Neuromuscular Facilitation on Cervical Range of Motion, Strength and Proprioception

the aim of the study was to investigate the immediate influence of proprioceptive neuromuscular facilitation on cervical range of motion, strength and proprioception

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

the study evaluates the influence of two proprioceptive neuromuscular facilitation techniques (PNF patterns and PNF stretching) on cervical proprioception. PNF techniques are regularly used techniques among physiotherapist. also there is a lack of studies that investigated the effect of PNF on cervical proprioception

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
104

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
    • Istanbul
      • Beşiktaş, Istanbul, Turkey, 34353
        • Bahcesehir university
    • İstanbul
      • Ataşehir, İstanbul, Turkey, 34755
        • Yeditepe University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Neck disability index score of 5 or less
  • Able to understand and follow instructions
  • Above 18 years old

Exclusion Criteria:

  • Cervical trauma
  • History of cervical inter-vertebral disc pathology
  • Rheumatic diseases
  • Whiplash syndrome
  • History of surgeries to the neck, face and shoulders
  • History of systemic diseases

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Screening
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: PNF pattern

PNF patterns were performed using Dynamic of reversals technique which is characterized as active motion alternating from one direction (agonist) to the opposite (antagonist) without relaxing. The cervical patterns consisted of

  1. Cervical flexion with right rotation followed by extension with left rotation.
  2. Cervical flexion with left rotation followed by extension with right rotation.
Other: Proprioceptive Neuromuscular Facilitation Patterns
The participants were asked to sit on a chair, the therapist performed the pattern of movement himself then passively applied the pattern on the participant then asked the participant to perform the pattern, and the therapist observed and corrected the movement if it was done improperly.Then participants were told that the therapist will resist their movement, they were also told to keep breathing normally and to report any discomfort and/or pain.After mastering the pattern,the therapist placed one hand on the participant's mandibular and the other hand approximately between parietal and occipital bones to apply resistance through out the ROM, each pattern performed for 3 sets of 10 repetitions with 1-2-minute rest between sets.
Experimental: PNF stretching
PNF stretching was done using contract-relax-antagonist contract (CRAC) technique for cervical flexors, extensors, right and left lateral flexors, right rotators and left rotators.
Other: Proprioceptive Neuromuscular Facilitation stretching
was done for 6 repetitions with hold for 6 seconds in position of stretch and sub maximal isometric contraction for 6 seconds, 1-2-minute rest was given before changing the target muscle group
Sham Comparator: control
Participants allocated to the control group received ineffective passive ROM.
Other: Passive range of motion
ineffective passive ROM for 10 repetitions for flexion, extension, right and left side bending and right and left rotation, it was done from neutral position to the limit of motion without causing any stretch to the muscle.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Cervical Proprioception: Joint position accuracy method using cervical range of motion instrument.
Time Frame: 1 day
Joint position accuracy method using cervical range of motion instrument. Participants were asked to sit and put on the CROM instrument, then they were instructed to start moving their head to one of directions then the assessor stopped them at 30 degrees and told them to feel the amount of movement and muscle tension, this was repeated 3 times as a reference, then they were asked to do the movement with the eyes closed until they reach the target angle, this was repeated for 3 times, this was done for each direction and the assessor recorded the results. Cervical proprioception was done for flexion, extension, right side bending, left side bending, right and left rotation
1 day

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Range Of Motion
Time Frame: 1 day

Active Range of motion (AROM) was measured using cervical range of motion instrument.

CROM instrument were placed on the participants head, then the assessor asked the participant to move towards the movement direction until they reach the limit.
1 day
Muscle strength
Time Frame: 1 day
The measurement were taken for cervical flexors, extensors, right and left rotators, right and left side benders, each was done in an against gravity position.
1 day

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Yeditepe University

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Bahçeşehir University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: SULE DEMIRBASISTANBUL, Yeditepe University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
February 20, 2019

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
May 27, 2019

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
May 27, 2019

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 1, 2019

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 2, 2019

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 5, 2019

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 29, 2019

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 26, 2019

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2019

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 10269393

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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