HealthyEffplantNCT02508766
Effect of Stimulating Plant on the Balance in Young Healthy
A study testing Plantar stimulation in people with Healthy, run by University of Valencia.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Plantar stimulation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 184 participants
- Where
- No sites listed yet
- Study dates
- Jul 2015to Jul 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Patients were included if they were healthy university students and were able and willing to complete the protocol
Who cannot join
- 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.
About this study
Official title: EFFECT OF MANUAL PLANTAR STIMULATION ON STATIC AND DYNAMIC POSTURAL CONTROL IN YOUNG HEALTHY SUBJECTS
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.
Read the 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.
- Conditions
- Healthy
- Being tested
- Plantar stimulation
- Keywords
- Postural Control, Plantar Stimulation, Volunteers
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Plantar stimulationProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Procedure: Plantar stimulation |
| Control group | No intervention | Volunteers received no intervention. They just sat there for 20 minutes before being evaluated. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 1 day
Secondary outcomes (2)
Static postural control testing: Unipedal Stance Test
Static balance was assessed using the UPST. Firstly, participants were asked to focus on a spot on the wall at eye level in front of them. Then, they had to cross their arms over the chest and close their eyes. Afterwards, subjects had to undergo the test barefoot standing on one leg on a stable surface, while maintaining balance for as long as possible up to a 45 second period. A stopwatch was used to determine the elapsed time the student was able to maintain unipedal stance up to a maximum of 45 seconds. The trial was disregarded and repeated when participants (1) touched the floor or moved the free foot from the standing limb, (2) uncrossed their arms, (3) moved the standing foot to maintain his balance or (4) opened eyes. Finally, subjects then completed 3 test trials, sitting in a chair to rest for 5 minutes. The average score of the amount of time of three trials was recorded.
Measured: 1 day
Dynamic postural control testing: Star Excursion Balance Test.
Consists of 8 directions, whilst several studies have confirmed the utility of a reduced version of the test using the anterior (ANT), posteromedial (PM) and posterolateral (PL) reaching directions. Participants were required to reach with the free limb for maximal distance in each of three directions and then lightly touch one line, while maintaining his/her balance and without using the free limb for support. Then, 3 trials in each direction for each limb were performed. Visual cues (objects on the floor, people not participating in the study, etc.) were avoided, in order to reduce visual and auditory influences. The trial was repeated when (1) the reach limb touched heavily at the floor, in order to maintain balance or to get any support, (2) moved the stance foot from the grid, (3) failed to return the reach foot to the starting position, or (4) subject's hands did not remain on his/her hips.
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jul 2015 (estimated)
- Study startJul 2015
- Primary completionJul 2015
- Study completionJul 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for HealthyStudies of the same condition, open and under way.
- More trials run by University of ValenciaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 184 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Valencia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, GEMMA V ESPÍ LÓPEZ, PhD, University of Valencia
- Investigators
- Gemma V Espí-López, PhD, Principal investigator, Faculty of Physiotherapy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02508766
- Sponsor's protocol ID
- ID010
- Acronym
- Effplant
- Status last verified
- Aug 2016
- First submitted
- 23 Jul 2015
- Last updated
- 2 Aug 2016
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 22546376Hurvitz 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.
PubMed 10807096Muir 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.
PubMed 21273076
Study at a glance
From the registry record, last updated by the sponsor on 2 Aug 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- EFFECT OF MANUAL PLANTAR STIMULATION ON STATIC AND DYNAMIC POSTURAL CONTROL IN YOUNG HEALTHY SUBJECTS
- ClinicalTrials.gov ID
- NCT02508766
- Acronym / sponsor ID
- Effplant / ID010
- Conditions
- Healthy
- Keywords
- Postural Control, Plantar Stimulation, Volunteers
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 184 participants (actual)
- Lead sponsor
- University of ValenciaUniversity, hospital or other
- Study start
- Jul 2015
- Primary completion
- Jul 2015 (actual)
- Study completion
- Jul 2015 (actual)
- First posted
- 27 Jul 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Plantar stimulation | Experimental | Procedure: Plantar stimulationThe 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. |
| Control group | No intervention | –Volunteers received no intervention. They just sat there for 20 minutes before being evaluated. |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Patients were included if they were healthy university students and were able and willing to complete the protocol
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Plantar stimulationThe 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 or surgery | Plantar stimulation |
Primary outcome
Anthropometric measurements (the measure is a composite)
Time frame: 1 day
* 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.
2 secondary outcomes
Static postural control testing: Unipedal Stance Test
Time frame: 1 day
Dynamic postural control testing: Star Excursion Balance Test.
Time frame: 1 day
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Aug 2016.
- Results publication: PubMed 22546376Hatton 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.
- Results publication: PubMed 10807096Hurvitz 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.
- Results publication: PubMed 21273076Muir 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gemma V Espí-López, PhD principal investigator
Faculty of Physiotherapy
Questions about this trial
What is this clinical trial studying?
A study testing Plantar stimulation in people with Healthy, run by University of Valencia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Aug 2016. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Anthropometric measurements (the measure is a composite) (time frame: 1 day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02508766, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Aug 2016; AzTrials last refreshed its copy on 8 Nov 2026.