NCT04444414

Brief Summary

The aims of this study was to compare the effectiveness of a protocol of manual therapy on the static balance, dynamic balance and mood states in health participants. This study will consist of a randomized controlled trial. Participants will be healthy subjects divided into 2 groups, being an experimental group that will receive a manual therapy session and a control group without treatment. It will be evaluated at the start of the study, after treatment and one week later.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
101

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jul 2020

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 6, 2020

Completed
17 days until next milestone

First Posted

Study publicly available on registry

June 23, 2020

Completed
8 days until next milestone

Study Start

First participant enrolled

July 1, 2020

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 15, 2020

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2020

Completed
Last Updated

January 10, 2023

Status Verified

January 1, 2023

Enrollment Period

2 months

First QC Date

June 6, 2020

Last Update Submit

January 9, 2023

Conditions

Outcome Measures

Primary Outcomes (1)

  • Star Excursion Balance Test (SEBT)

    It consists of reaching the lower limb as much as possible, in a standing position, while the other lower limb is kept on a stable support base, at a certain point. The reaches of the leg are evaluated using three determined directions, such as the anterior, the postero-medial and the postero-lateral.

    1-week

Secondary Outcomes (3)

  • Unipedal Stance Test (UPST)

    1-week

  • Patient Global Impression of Change (PGIC)

    1-week

  • POMS (Profile Of Mood States)

    1-week

Study Arms (2)

Manual Therapy group

EXPERIMENTAL

Bilateral manipulation lumbosacral, hip joint gapping, stretching the hip rotators with hip and knee flexion, femorotibial gapping, decompression of connective tissue of the patellofemoral region, internal and external joint line opening in laterality, mobilization of the base of the fibula, tibiofibular-talus gapping, and muscle strengthening.

Other: Manual therapy

Control group

OTHER

They received no treatment, they just went to the evaluations.

Other: Control group

Interventions

bilateral manipulation lumbosacral, hip joint gapping, stretching the hip rotators with hip and knee flexion, femorotibial gapping, decompression of connective tissue of the patellofemoral region, internal and external joint line opening in laterality, mobilization of the base of the fibula, tibiofibular-talus gapping, and muscle strengthening.

Manual Therapy group

The control group received no treatment, they only attended the evaluations.

Control group

Eligibility Criteria

Age18 Years - 30 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Age between 18 and 30 years
  • That they can take all the tests from the study evaluations.

You may not qualify if:

  • Those who are doing some balance training program.
  • Individuals who have some deterioration in balance, regardless of whether the cause is the vestibular system, the visual, proprioceptive, any surgery.
  • Participants suffering from tingling or numbness.
  • Those who have pain in the lower limbs greater than 3 on the Visual Analog Scale.
  • That the lower limbs or in the lumbosacral region have orthopedic problems or traumatic injuries, they will not be able to participate either, including as such scoliosis, ligament pathologies, osteoarthritis, prostheses.
  • Pregnancy.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Gemma Espí

Valencia, 46010, Spain

Location

Related Publications (2)

  • Espi-Lopez GV, Serra-Ano P, Vicent-Ferrando J, Sanchez-Moreno-Giner M, Arias-Buria JL, Cleland J, Fernandez-de-Las-Penas C. Effectiveness of Inclusion of Dry Needling in a Multimodal Therapy Program for Patellofemoral Pain: A Randomized Parallel-Group Trial. J Orthop Sports Phys Ther. 2017 Jun;47(6):392-401. doi: 10.2519/jospt.2017.7389. Epub 2017 May 13.

    PMID: 28504067BACKGROUND
  • Espi-Lopez GV, Lopez-Martinez S, Ingles M, Serra-Ano P, Aguilar-Rodriguez M. Effect of manual therapy versus proprioceptive neuromuscular facilitation in dynamic balance, mobility and flexibility in field hockey players. A randomized controlled trial. Phys Ther Sport. 2018 Jul;32:173-179. doi: 10.1016/j.ptsp.2018.04.017. Epub 2018 Apr 22.

    PMID: 29793126BACKGROUND

MeSH Terms

Interventions

Musculoskeletal ManipulationsControl Groups

Intervention Hierarchy (Ancestors)

Complementary TherapiesTherapeuticsPhysical Therapy ModalitiesRehabilitationEpidemiologic Research DesignEpidemiologic MethodsInvestigative TechniquesResearch DesignMethods

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Masking Details
The subject does not know the group that belonged The evaluator and therapist were different people
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: A randomized controlled trial with 2 groups (experimental and control)
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

June 6, 2020

First Posted

June 23, 2020

Study Start

July 1, 2020

Primary Completion

August 15, 2020

Study Completion

November 1, 2020

Last Updated

January 10, 2023

Record last verified: 2023-01

Data Sharing

IPD Sharing
Will not share

Locations