NCT04045106

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

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

Enrollment
104

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Feb 2019

Shorter than P25 for not_applicable

Geographic Reach
1 country

2 active sites

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

Study Start

First participant enrolled

February 20, 2019

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 27, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 27, 2019

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

August 1, 2019

Completed
4 days until next milestone

First Posted

Study publicly available on registry

August 5, 2019

Completed
Last Updated

August 29, 2019

Status Verified

July 1, 2019

Enrollment Period

3 months

First QC Date

August 1, 2019

Last Update Submit

August 26, 2019

Conditions

Keywords

ProprioceptionProprioceptive Neuromuscular Facilitation,Cervical spinestretching

Outcome Measures

Primary Outcomes (1)

  • Cervical Proprioception: Joint position accuracy method using cervical range of motion instrument.

    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 Outcomes (2)

  • Range Of Motion

    1 day

  • Muscle strength

    1 day

Study Arms (3)

PNF pattern

EXPERIMENTAL

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

PNF stretching

EXPERIMENTAL

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

control

SHAM COMPARATOR

Participants allocated to the control group received ineffective passive ROM.

Other: Passive range of motion

Interventions

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.

PNF pattern

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

PNF stretching

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.

control

Eligibility Criteria

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

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Yeditepe University

Ataşehir, Istanbul, 34755, Turkey (Türkiye)

Location

Bahcesehir University

Beşiktaş, Istanbul, 34353, Turkey (Türkiye)

Location

MeSH Terms

Interventions

Muscle Stretching ExercisesRange of Motion, Articular

Intervention Hierarchy (Ancestors)

Exercise TherapyRehabilitationAftercareContinuity of Patient CarePatient CareTherapeuticsPhysical Therapy ModalitiesExerciseMotor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological PhenomenaPhysical ExaminationDiagnostic Techniques and ProceduresDiagnosis

Study Officials

  • SULE DEMIRBASISTANBUL

    Yeditepe University

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
SCREENING
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 1, 2019

First Posted

August 5, 2019

Study Start

February 20, 2019

Primary Completion

May 27, 2019

Study Completion

May 27, 2019

Last Updated

August 29, 2019

Record last verified: 2019-07

Data Sharing

IPD Sharing
Will not share

Locations