NCT02508766

Brief Summary

The primary purpose of this study was to examine the immediate effect of manual stimulation on the foot plant in static and dynamic balance in young healthy subjects. In addition, the secondary objectives of this study were: 1) to identify whether manual stimulation of the foot plant in healthy young subjects, carried out with an easily reproducible protocol with 10 minutes duration, improves static balance, measured with Unipedal Stance Test; 2) to assess whether, manual stimulation of the foot plant in healthy young subjects, carried out with an easily reproducible protocol with 10 minutes duration, improves dynamic balance test, measured with Star Excursion Balance Test.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
184

participants targeted

Target at P75+ for not_applicable healthy

Timeline
Completed

Started Jul 2015

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

Study Start

First participant enrolled

July 1, 2015

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2015

Completed
22 days until next milestone

First Submitted

Initial submission to the registry

July 23, 2015

Completed
4 days until next milestone

First Posted

Study publicly available on registry

July 27, 2015

Completed
Last Updated

August 2, 2016

Status Verified

August 1, 2016

Enrollment Period

Same day

First QC Date

July 23, 2015

Last Update Submit

August 1, 2016

Conditions

Keywords

Postural ControlPlantar StimulationVolunteers

Outcome Measures

Primary Outcomes (1)

  • Anthropometric measurements (the measure is a composite)

    * Height (cm) * Mass (kg). Body mass index was calculated from height and mass data (kg/m2). * Bilateral leg length measures (cm). On a plinth with participant in supine, leg length was assessed using a standard tape measure. The distance between the anterior superior iliac spine and the most distal portion of the medial malleolus of the same leg was measured. Both legs were evaluated.

    1 day

Secondary Outcomes (2)

  • Static postural control testing: Unipedal Stance Test

    1 day

  • Dynamic postural control testing: Star Excursion Balance Test.

    1 day

Study Arms (2)

Plantar stimulation

EXPERIMENTAL

The manipulation was performed with the subject in the supine position. The intervention lasted ten minutes and consisted of four stages: 5 glide pressures focused on each interdigital space, that lasted 10 seconds in duration, 5 compression-decompression of each metatarsophalangeal joint, 5 glide pressures applied for 5 seconds each, on the region of metatarsal heads, 5 static pressures applied for 10 seconds each, focused on four points of the sole.

Procedure: Plantar stimulation

Control group

NO INTERVENTION

Volunteers received no intervention. They just sat there for 20 minutes before being evaluated.

Interventions

The manipulation was performed with the subject in the supine position. The intervention lasted ten minutes and consisted of four stages: 5 glide pressures focused on each interdigital space, that lasted 10 seconds in duration, 5 compression-decompression of each metatarsophalangeal joint, 5 glide pressures applied for 5 seconds each, on the region of metatarsal heads, 5 static pressures applied for 10 seconds each, focused on four points of the sole.

Plantar stimulation

Eligibility Criteria

Age18 Years - 40 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Patients were included if they were healthy university students and were able and willing to complete the protocol

You may not qualify if:

  • Had a known musculoskeletal lower extremity injury (eg, postoperative conditions, musculotendinous or ligamentous problems).
  • Previous history of neurological problems.
  • Balance disorders (eg, vestibular or visual problems).
  • Did some type of physical activity programme where balance exercises were performed.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (3)

  • Hatton AL, Dixon J, Rome K, Newton JL, Martin DJ. Altering gait by way of stimulation of the plantar surface of the foot: the immediate effect of wearing textured insoles in older fallers. J Foot Ankle Res. 2012 Apr 30;5:11. doi: 10.1186/1757-1146-5-11.

  • Hurvitz EA, Richardson JK, Werner RA, Ruhl AM, Dixon MR. Unipedal stance testing as an indicator of fall risk among older outpatients. Arch Phys Med Rehabil. 2000 May;81(5):587-91. doi: 10.1016/s0003-9993(00)90039-x.

  • Muir J, Judex S, Qin YX, Rubin C. Postural instability caused by extended bed rest is alleviated by brief daily exposure to low magnitude mechanical signals. Gait Posture. 2011 Mar;33(3):429-35. doi: 10.1016/j.gaitpost.2010.12.019. Epub 2011 Jan 26.

Study Officials

  • Gemma V Espí-López, PhD

    Faculty of Physiotherapy

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
FACTORIAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PhD

Study Record Dates

First Submitted

July 23, 2015

First Posted

July 27, 2015

Study Start

July 1, 2015

Primary Completion

July 1, 2015

Study Completion

July 1, 2015

Last Updated

August 2, 2016

Record last verified: 2016-08