NCT03084341

Brief Summary

The main objective of this study is to compare the effect and the duration of the Neuromuscular Electrical Elongation (NMEE ) technique versus the PNF technique and versus a control group, on the extensibility of the hamstrings muscles. Hypothesis: NMEE of shortened hamstrings muscles in healthy subjects, compared with PNF and control group produces a significant increase in hamstrings extensibility.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
96

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Mar 2017

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

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

First Submitted

Initial submission to the registry

November 7, 2016

Completed
4 months until next milestone

Study Start

First participant enrolled

March 13, 2017

Completed
7 days until next milestone

First Posted

Study publicly available on registry

March 20, 2017

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2017

Completed
29 days until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2017

Completed
Last Updated

January 12, 2021

Status Verified

January 1, 2021

Enrollment Period

3 months

First QC Date

November 7, 2016

Last Update Submit

January 11, 2021

Conditions

Keywords

ElasticityElectric StimulationMuscle Stretching Exercises

Outcome Measures

Primary Outcomes (2)

  • Change in Active-knee-extension test (AKE)

    The AKE is performed using an experimental apparatus designed specifically for this investigation. It consists of a rectangular wooden frame that is attached to an examination table. The tested limb is flexed until the thigh touched the wooden frame, being at 90° with the table. The contralateral limb is fully extended and stabilized in neutral rotation by a second examiner. With the foot in neutral position and the knee flexed at 90°, a standard universal goniometer is placed over the lateral femoral condyle, with 1 arm aligned along the thigh in direction to the greater trochanter and the other arm aligned over the leg in the direction of the lateral malleolus. From this position, and without any prior warm-up subjects will be instructed to extend the knee until they felt a strong resistance, holding this final position for 2 to 3 seconds to allow the goniometric reading.

    Pre-intervention; Post-intervention (30 minutes after intervention); Follow up (4 week after last intervention)

  • Change in Straight-leg-raise test (SLR)

    For the SLR test, a normal examination table is used. Participants lay supine and must be relaxed throughout the test. The tested limb is flexed by the examiner, with the knee fully extended and the foot in a relaxed position. The contralateral limb is secured by a second examiner, fully extended and in neutral rotation. The movement stops when the tester feels a strong resistance or when pelvic rotation is observed. The goniometer is placed over the greater trochanter, with 1 arm aligned with the lateral femoral condyle and the other aligned parallel to the table, in the direction of the midaxillary line.

    Pre-intervention; Post-intervention (30 minutes after intervention); Follow up (4 week after last intervention)

Secondary Outcomes (5)

  • Change in Quadriceps Muscle Extensibility

    Pre-intervention; Post-intervention (30 minutes after intervention); Follow up (4 week after last intervention)

  • Change in Frequency

    Pre-intervention; Post-intervention (30 minutes after intervention); Follow up (4 week after last intervention)

  • Change in Stiffness

    Pre-intervention; Post-intervention (30 minutes after intervention); Follow up (4 week after last intervention)

  • Change in Decrement (elasticity)

    Pre-intervention; Post-intervention (30 minutes after intervention); Follow up (4 week after last intervention)

  • Change in Neural Measures

    Pre-intervention; Post-intervention (30 minutes after intervention); Follow up (4 week after last intervention)

Study Arms (3)

NMEE Group

ACTIVE COMPARATOR

Neuromuscular Electrical Elongation

Procedure: Neuromuscular Electrical Elongation

PNF Group

ACTIVE COMPARATOR

Proprioceptive Neuromuscular Facilitation stretching

Procedure: Proprioceptive Neuromuscular Facilitation

Control Group

NO INTERVENTION

No intervention

Interventions

Electrotherapy equipment will be used, choosing an interferential current through bipolar application,with a frequency of 4 kHz and a frequency modulation amplitude of 100 Hz.

NMEE Group

Hold-relax technique that involves lengthening the muscle to the point of limitation, at which point the individual performs an isometric contraction for up to 10 s, followed by a passive movement of the limb into the new end-range.

PNF Group

Eligibility Criteria

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

You may qualify if:

  • Healthy Volunteers
  • Older than 18 years
  • Bilateral shortened hamstrings muscles with a knee extension under 60º (TEAR, Neto et al., 2015) and a ROM under 80º in the hip (straight leg raise test angle, Espejo-Antúnez et al., 2015)

You may not qualify if:

  • Participation in a muscular stretching program during the study
  • Previous history of surgical intervention in the hip, tight or knee
  • Muscle-skeletal pain or injury in the low back or inferior limbs
  • Abdominal o spine surgery within three month before the study beginning.
  • Exit Criteria:
  • Patient´s petition
  • Change in the regular physical activity level during the study period
  • Appearance of an injury that would contraindicate the use of stretching techniques

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Universidad San Jorge

Villanueva de Gállego, Zaragoza, 50830, Spain

Location

MeSH Terms

Interventions

Muscle Stretching Exercises

Intervention Hierarchy (Ancestors)

Exercise TherapyRehabilitationAftercareContinuity of Patient CarePatient CareTherapeuticsPhysical Therapy ModalitiesExerciseMotor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • Maria Ortiz-Lucas

    Universidad San Jorge

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

November 7, 2016

First Posted

March 20, 2017

Study Start

March 13, 2017

Primary Completion

June 1, 2017

Study Completion

June 30, 2017

Last Updated

January 12, 2021

Record last verified: 2021-01

Data Sharing

IPD Sharing
Will not share

Locations