Clinical trial NCT02508766: Effect of Stimulating Plant on the Balance in Young Healthy
Official title: EFFECT OF MANUAL PLANTAR STIMULATION ON STATIC AND DYNAMIC POSTURAL CONTROL IN YOUNG HEALTHY SUBJECTS
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy
Keywords: Postural Control
Plantar Stimulation
Volunteers
Lead sponsor: University of Valencia
Sponsor class: OTHER
First posted: 2015-07-27
Enrollment: 184
Sex: ALL
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: TREATMENT

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.

Detailed description: Methods Participants Participants from the University of Valencia (Spain) were asked to volunteer to participate in this study. Patients were included if they were university students and were able and willing to complete the protocol. Participants were excluded if they were ≥40 years-old or 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) or did some type of physical activity programme where balance exercises were performed.

Study design We conducted a randomized single-blind controlled study investigation. A non-stratified randomization list was generated and held centrally in sealed envelopes. Therefore, participants were randomly assigned to an experimental group, who received a plantar stimulation on the right foot, or to a control group, which did not receive any intervention.

Intervention Plantar stimulation In addition, a plantar stimulation directed at the plantar surface of the dominant foot was performed by an experienced physiotherapist, as described below. Participants performed one practice trial of plantar stimulation prior to performance. 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 and on the internal longitudinal arch of the foot in a caudal direction, that lasted 10 seconds in duration, (2) 5 compression-decompression of each metatarsophalangeal joint, until a slight tension was perceived by the researcher at the joint, (3) 5 glide pressures applied for 5 seconds each, on the region of metatarsal heads, and (4) 5 static pressures applied for 10 seconds each, focused on four points of the sole: the head of the first and the fifth metatarsal head, the heel and the medial side of the midfoot (Figure 3). Duration of pressures was assessed by using an on-line metronome. Furthermore, all pressures, both static and glide, were measured by a strength dynamometer and the mean force of pressure was 48N. After the stimulation, given to the negative effects of the sudden standing-up on several study results, participants stood quietly for 20 seconds before balance tests.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Anthropometric measurements (the measure is a composite)
timeFrame: 1 day
Secondary outcomes:
measure: Static postural control testing: Unipedal Stance Test
timeFrame: 1 day
measure: Dynamic postural control testing: Star Excursion Balance Test.
timeFrame: 1 day
Other outcomes:
Locations:
Study officials:
affiliation: Faculty of Physiotherapy
name: Gemma V Espí-López, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.