Foot Strength DeficitNCT05216692

Morphological and Functional Effects of a Foot Strengthening Protocol

A study testing La Tour Hospital Foot Strengthening Protocol and Standard Literature Foot Strengthening Protocol in people with Foot Strength Deficit, run by François Fourchet at 1 site in Switzerland.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

The principal aim of this study is to investigate the effects of a four-week foot strenghtening protocol combining active voluntary exercises and assisted-active voluntary exercises by neuromuscular electrical stimulation on hallux toe flexion strength in comparison to a standard foot strengthening protocol in a… Read more about this study

Who is it for?: Ages 18 to 50 yearsHealthy volunteers can take part
Conditions the study is for: Foot Strength Deficit
What is being tested?: La Tour Hospital Foot Strengthening Protocol and Standard Literature Foot Strengthening Protocol
Type of treatment: Surgery or procedure
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 28 participants
Where: 1 siteSwitzerland
Study dates: 3 Jan 2022to 11 Feb 2022
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 50 years
All sexes
Healthy volunteers accepted
Adult

Who may be able to join

Level of weekly physical activity (recreational activity and regular non-competitive runners : at least 1 running session per week)

Who cannot join

History of pain or episodes of foot or ankle sprains during the past 6 months;
Foot or leg fractures during the past year;
Severe deformity of the foot or leg;
Self-declared disability due to neuromuscular impairment of the lower limbs;
Neurological or vestibular deficit that could hinder balance (diabetes mellitus, radiculopathie lumbosacral, soft tissue disorder such as Marfan or Ehlers-Danlos syndrome) ;
Any absolute contraindication to neuromuscular electrical stimulation (NMES) (cardiac pacemaker, epileptic disorders, pregnancy defibrillator);
Participation in an exercise program specifically designed to strengthen the ankle or foot during the last 6 months

Trial locations and contacts

1 site in 1 country.

Switzerland1 site

Hopital de La Tour, Service de Physiothérapie
Meyrin, Canton of Geneva, 1217

Other trials in Switzerland

About this study

Official title: Effects of a Foot Strengthening Protocol on Foot Strength, Foot Morphological Deformation and Kinetics Parameters : a Monocentric Randomized Controlled Trial

The secondary objectives of the study are to investigate the effects of this protocol on lesser toes flexor strength, foot morphology deformation in one, two and three dimensions and kinetic parameters when walking and running.

Conditions: Foot Strength Deficit
Being tested: La Tour Hospital Foot Strengthening Protocol, Standard Literature Foot Strengthening Protocol

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

La Tour Hospital Foot Strengthening ProtocolProcedure or surgery
First exercise : "NMES forward lean doming". Doming exercise assisted by NMES placed on the IFM. 8 sec of contraction (6 sec rest) moving the trunk forward. 12 repetitions, 3 sets. Progressive increase of the intensity of NEMS during 4 weeks and increase of body load while decreasing the number of repetitions.
Second exercise : "MTP joint flexion". Isometric MTP joint flexion contractions. 4 contractions of 5 sec (10 sec rest), 3 sets. Progressive increase of the number of MVIC during 4 weeks and of increase body load while keeping the same intensity.
Third exercise : "Foot-ankle rebound". Multiple jumps with only plantar flexion. Keeping the knee stiff and straight and pushing off the ground with only ankle and MTP plantar flexion by a forefoot contact with the ground. 10 seconds of jump (1 min of rest) during 5 sets. Progressive increase of body load while keeping the same intensity.
Standard Literature Foot Strengthening ProtocolProcedure or surgery
During the 1st week, the participants will perform the "Short foot exercise" (SFE) during 3 series of 10 repetitions of 5 seconds of contractions in sitting position. 1 minute of rest will be give between series.
During the 2nd week, the participants will perform the SFE during 3 series of 15 repetitions of 5 seconds of contractions in sitting position. 1 minute of rest will be give between series.
During the 3rd week, the participants will perform the SFE during 3 series of 15 repetitions of 5 seconds of contractions in standing bipedal position. 1 minute of rest will be give between series.
During the 4th week, the participants will perform the SFE during 3 series of 15 repetitions of 5 seconds of contractions in standing unipedal position. 1 minute of rest will be give between series.
The progression of the exercise during the protocol will be based on passing from a sitting position to a unipedal standing position.

Study groups in NCT05216692
Study group	Role	What they receive
Experimental group	Experimental	The foot strengthening protocol will last 4 weeks with 2 sessions per week and is composed of 3 exercises targeting forefoot and midfoot region strength as well as enhancing plyometric capabilities of the foot complex. Receives: Procedure: La Tour Hospital Foot Strengthening Protocol
Control group	Active comparator	The standard literature foot strengthening protocol will last 4 weeks with 3 sessions per week and is composed of one exercise targeting the strength of the foot medial arch. Receives: Procedure: Standard Literature Foot Strengthening Protocol

What is being measured

The primary outcome is the main question the study is designed to answer.

Change in Hallux flexion strength
Hallux flexion strength will be assessed by a MicroFET2 Handheld Digital Dynamometer in hook lying position. The strength will be normalized by bodyweight (N/kg).
Measured: All measures will be collected on both feet 1 week prior the treatment and 1 week after the last intervention session

Secondary outcomes (8)

Change in Lesser toe flexion strength
Lesser toe flexion strength will be assessed by a MicroFET2 Handheld Digital Dynamometer in hook lying position. The strength will be normalized by bodyweight (N/kg).
Measured: All measures will be collected on both feet 1 week prior the treatment and 1 week after the last intervention session
Change in Foot morphological deformation
Foot morphological deformation in 1, 2 and 3 dimensions will be assessed thanks to the Arch Height Index Measurement System (AHIMS, JAKTOOL Corporation, Cranberry, NJ) by measuring the change of the total foot length, foot width, truncated foot length, dorsal arch height, navicular height measurements in a sitting position (10% of bodyweight) to a standing position (95% of bodyweight). The percentage of loading during the measurement will be checked by performing the measurement of force platform.
Measured: All measures will be collected on both feet 1 week prior the treatment and 1 week after the last intervention session
Change in Running and walking kinetics : Time parameters
Running kinetic parameters when walking and running will be assessed with an instrumented treadmill (Zebris FDM-THQ, ZebrisMedicalGmbH, Germany). The variables collected will be mean contact time (s), mean flight time (s), and the duration (s) on 7-foot regions (heel 1, heel 2, midfoot, forefoot 1, forefoot 2, forefoot 3, toes) will be assessed during 40 seconds of acquisition at self-selected speed during walking and running.
Measured: All measures will be collected on both feet 1 week prior the treatment and 1 week after the last intervention session
Change in Running and walking kinetics : Force parameters
Running kinetic parameters when walking and running will be assessed with an instrumented treadmill (Zebris FDM-THQ, ZebrisMedicalGmbH, Germany). The variables collected will be mean vertical force (N) and peak force (N) on 7-foot regions (heel 1, heel 2, midfoot, forefoot 1, forefoot 2, forefoot 3, toes) during 40 seconds of acquisition at self-selected speed during walking and running.
Measured: All measures will be collected on both feet 1 week prior the treatment and 1 week after the last intervention session
Change in Running and walking kinetics : Distance parameters
Running kinetic parameters when walking and running will be assessed with an instrumented treadmill (Zebris FDM-THQ, ZebrisMedicalGmbH, Germany). The variables collected will be step length (cm) and step width (cm) during 40 seconds of acquisition at self-selected speed during walking and running.
Measured: All measures will be collected on both feet 1 week prior the treatment and 1 week after the last intervention session
Change in Running and walking kinetics : Stiffness parameter
Running kinetic parameters when walking and running will be assessed with an instrumented treadmill (Zebris FDM-THQ, ZebrisMedicalGmbH, Germany). The variable collected will be mean kleg (Kn/m) during 40 seconds of acquisition at self-selected speed during walking and running.
Measured: All measures will be collected on both feet 1 week prior the treatment and 1 week after the last intervention session
Change in Running and walking kinetics : Frequency parameter
Running kinetic parameters when walking and running will be assessed with an instrumented treadmill (Zebris FDM-THQ, ZebrisMedicalGmbH, Germany). The variable collected will be step frequency (step/min) during 40 seconds of acquisition at self-selected speed during walking and running.
Measured: All measures will be collected on both feet 1 week prior the treatment and 1 week after the last intervention session
Change in Running and walking kinetics : Pressure parameter
Running kinetic parameters when walking and running will be assessed with an instrumented treadmill (Zebris FDM-THQ, ZebrisMedicalGmbH, Germany). The variable collected will be the maximal pressure (N/cm²) on 7-foot regions (heel 1, heel 2, midfoot, forefoot 1, forefoot 2, forefoot 3, toes) during 40 seconds of acquisition at self-selected speed during walking and running.
Measured: All measures will be collected on both feet 1 week prior the treatment and 1 week after the last intervention session

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

3 Jan 202211 Feb 2022

First posted31 Jan 2022
Study start3 Jan 2022
Primary completion11 Feb 2022
Study completion11 Feb 2022

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (13)Papers the sponsor has linked to this study.
Other trials for Foot Strength DeficitStudies of the same condition, open and under way.
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: Parallel groups
Model description: Randomized Controlled Trial
Masking: Single blind
Who is masked: Outcomes assessor
Enrolment: 28 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05216692
Sponsor's protocol ID: 2021-D0041
Status last verified: Apr 2022
First submitted: 14 Dec 2021
Last updated: 20 Apr 2022
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: Undecided

Publications

Fraser JJ, Hertel J. Effects of a 4-Week Intrinsic Foot Muscle Exercise Program on Motor Function: A Preliminary Randomized Control Trial. J Sport Rehabil. 2019 May 1;28(4):339-349. doi: 10.1123/jsr.2017-0150. Epub 2018 Dec 4.
PubMed 29364026
Kim KM, Croy T, Hertel J, Saliba S. Effects of neuromuscular electrical stimulation after anterior cruciate ligament reconstruction on quadriceps strength, function, and patient-oriented outcomes: a systematic review. J Orthop Sports Phys Ther. 2010 Jul;40(7):383-91. doi: 10.2519/jospt.2010.3184.
PubMed 20592480
Namsawang J, Eungpinichpong W, Vichiansiri R, Rattanathongkom S. Effects of the Short Foot Exercise With Neuromuscular Electrical Stimulation on Navicular Height in Flexible Flatfoot in Thailand: A Randomized Controlled Trial. J Prev Med Public Health. 2019 Jul;52(4):250-257. doi: 10.3961/jpmph.19.072. Epub 2019 Jul 14.
PubMed 31390688
Taddei UT, Matias AB, Ribeiro FIA, Bus SA, Sacco ICN. Effects of a foot strengthening program on foot muscle morphology and running mechanics: A proof-of-concept, single-blind randomized controlled trial. Phys Ther Sport. 2020 Mar;42:107-115. doi: 10.1016/j.ptsp.2020.01.007. Epub 2020 Jan 13.
PubMed 31962191
McKeon PO, Hertel J, Bramble D, Davis I. The foot core system: a new paradigm for understanding intrinsic foot muscle function. Br J Sports Med. 2015 Mar;49(5):290. doi: 10.1136/bjsports-2013-092690. Epub 2014 Mar 21.
PubMed 24659509
Gooding TM, Feger MA, Hart JM, Hertel J. Intrinsic Foot Muscle Activation During Specific Exercises: A T2 Time Magnetic Resonance Imaging Study. J Athl Train. 2016 Aug;51(8):644-650. doi: 10.4085/1062-6050-51.10.07. Epub 2016 Oct 3.
PubMed 27690528
Fourchet F, Kuitunen S, Girard O, Beard AJ, Millet GP. Effects of Combined Foot/Ankle Electromyostimulation and Resistance Training on the In-Shoe Plantar Pressure Patterns during Sprint in Young Athletes. J Sports Sci Med. 2011 Jun 1;10(2):292-300. eCollection 2011.
PubMed 24149874
Gaillet JC, Biraud JC, Bessou M, Bessou P. Modifications of baropodograms after transcutaneous electric stimulation of the abductor hallucis muscle in humans standing erect. Clin Biomech (Bristol). 2004 Dec;19(10):1066-9. doi: 10.1016/j.clinbiomech.2004.03.005.
PubMed 15531058
Fiolkowski P, Brunt D, Bishop M, Woo R, Horodyski M. Intrinsic pedal musculature support of the medial longitudinal arch: an electromyography study. J Foot Ankle Surg. 2003 Nov-Dec;42(6):327-33. doi: 10.1053/j.jfas.2003.10.003.
PubMed 14688773
Soysa A, Hiller C, Refshauge K, Burns J. Importance and challenges of measuring intrinsic foot muscle strength. J Foot Ankle Res. 2012 Nov 26;5(1):29. doi: 10.1186/1757-1146-5-29.
PubMed 23181771
Kelly LA, Kuitunen S, Racinais S, Cresswell AG. Recruitment of the plantar intrinsic foot muscles with increasing postural demand. Clin Biomech (Bristol). 2012 Jan;27(1):46-51. doi: 10.1016/j.clinbiomech.2011.07.013. Epub 2011 Aug 23.
PubMed 21864955
Kelly LA, Lichtwark G, Cresswell AG. Active regulation of longitudinal arch compression and recoil during walking and running. J R Soc Interface. 2015 Jan 6;12(102):20141076. doi: 10.1098/rsif.2014.1076.
PubMed 25551151
Kelly LA, Farris DJ, Lichtwark GA, Cresswell AG. The Influence of Foot-Strike Technique on the Neuromechanical Function of the Foot. Med Sci Sports Exerc. 2018 Jan;50(1):98-108. doi: 10.1249/MSS.0000000000001420.
PubMed 28902682

Study at a glance

From the registry record, last updated by the sponsor on 20 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Effects of a Foot Strengthening Protocol on Foot Strength, Foot Morphological Deformation and Kinetics Parameters : a Monocentric Randomized Controlled Trial
ClinicalTrials.gov ID: NCT05216692
Acronym / sponsor ID: 2021-D0041
Conditions: Foot Strength Deficit
Study type: Interventional
Recruitment status: Completed
Enrolment: 28 participants (actual)
Lead sponsor: François FourchetUniversity, hospital or other
Study start: 3 Jan 2022 (actual)
Primary completion: 11 Feb 2022 (actual)
Study completion: 11 Feb 2022 (actual)
First posted: 31 Jan 2022 (actual)
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.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind (outcomes assessor)
Number of arms: 2
Model description: Randomized Controlled Trial

Arm	Type	Receives
Experimental group	Experimental	Procedure: La Tour Hospital Foot Strengthening ProtocolThe foot strengthening protocol will last 4 weeks with 2 sessions per week and is composed of 3 exercises targeting forefoot and midfoot region strength as well as enhancing plyometric capabilities of the foot complex.
Control group	Active comparator	Procedure: Standard Literature Foot Strengthening ProtocolThe standard literature foot strengthening protocol will last 4 weeks with 3 sessions per week and is composed of one exercise targeting the strength of the foot medial arch.

Who may qualify

Ages: 18 to 50 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (1 listed)

Level of weekly physical activity (recreational activity and regular non-competitive runners : at least 1 running session per week)

Key exclusion criteria (7 listed)

History of pain or episodes of foot or ankle sprains during the past 6 months;
Foot or leg fractures during the past year;
Severe deformity of the foot or leg;
Self-declared disability due to neuromuscular impairment of the lower limbs;
Neurological or vestibular deficit that could hinder balance (diabetes mellitus, radiculopathie lumbosacral, soft tissue disorder such as Marfan or Ehlers-Danlos syndrome) ;

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
La Tour Hospital Foot Strengthening ProtocolFirst exercise : "NMES forward lean doming". Doming exercise assisted by NMES placed on the IFM. 8 sec of contraction (6 sec rest) moving the trunk forward. 12 repetitions, 3 sets. Progressive increase of the intensity of NEMS during 4 weeks and increase of body load while decreasing the number of repetitions. Second exercise : "MTP joint flexion". Isometric MTP joint flexion contractions. 4 contractions of 5 sec (10 sec rest), 3 sets. Progressive increase of the number of MVIC during 4 weeks and of increase body load while keeping the same intensity. Third exercise : "Foot-ankle rebound". Multiple jumps with only plantar flexion. Keeping the knee stiff and straight and pushing off the ground with only ankle and MTP plantar flexion by a forefoot contact with the ground. 10 seconds of jump (1 min of rest) during 5 sets. Progressive increase of body load while keeping the same intensity.	Procedure or surgery	Experimental group
Standard Literature Foot Strengthening ProtocolDuring the 1st week, the participants will perform the "Short foot exercise" (SFE) during 3 series of 10 repetitions of 5 seconds of contractions in sitting position. 1 minute of rest will be give between series. During the 2nd week, the participants will perform the SFE during 3 series of 15 repetitions of 5 seconds of contractions in sitting position. 1 minute of rest will be give between series. During the 3rd week, the participants will perform the SFE during 3 series of 15 repetitions of 5 seconds of contractions in standing bipedal position. 1 minute of rest will be give between series. During the 4th week, the participants will perform the SFE during 3 series of 15 repetitions of 5 seconds of contractions in standing unipedal position. 1 minute of rest will be give between series. The progression of the exercise during the protocol will be based on passing from a sitting position to a unipedal standing position.	Procedure or surgery	Control group

Primary outcome

Change in Hallux flexion strength
Time frame: All measures will be collected on both feet 1 week prior the treatment and 1 week after the last intervention session
Hallux flexion strength will be assessed by a MicroFET2 Handheld Digital Dynamometer in hook lying position. The strength will be normalized by bodyweight (N/kg).

8 secondary outcomes

Change in Lesser toe flexion strength
Time frame: All measures will be collected on both feet 1 week prior the treatment and 1 week after the last intervention session
Change in Foot morphological deformation
Time frame: All measures will be collected on both feet 1 week prior the treatment and 1 week after the last intervention session
Change in Running and walking kinetics : Time parameters
Time frame: All measures will be collected on both feet 1 week prior the treatment and 1 week after the last intervention session
Change in Running and walking kinetics : Force parameters
Time frame: All measures will be collected on both feet 1 week prior the treatment and 1 week after the last intervention session
Change in Running and walking kinetics : Distance parameters
Time frame: All measures will be collected on both feet 1 week prior the treatment and 1 week after the last intervention session
Change in Running and walking kinetics : Stiffness parameter
Time frame: All measures will be collected on both feet 1 week prior the treatment and 1 week after the last intervention session
Change in Running and walking kinetics : Frequency parameter
Time frame: All measures will be collected on both feet 1 week prior the treatment and 1 week after the last intervention session
Change in Running and walking kinetics : Pressure parameter
Time frame: All measures will be collected on both feet 1 week prior the treatment and 1 week after the last intervention session

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 20 Apr 2022.
Results publication: PubMed 29364026Fraser JJ, Hertel J. Effects of a 4-Week Intrinsic Foot Muscle Exercise Program on Motor Function: A Preliminary Randomized Control Trial. J Sport Rehabil. 2019 May 1;28(4):339-349. doi: 10.1123/jsr.2017-0150. Epub 2018 Dec 4.
Results publication: PubMed 20592480Kim KM, Croy T, Hertel J, Saliba S. Effects of neuromuscular electrical stimulation after anterior cruciate ligament reconstruction on quadriceps strength, function, and patient-oriented outcomes: a systematic review. J Orthop Sports Phys Ther. 2010 Jul;40(7):383-91. doi: 10.2519/jospt.2010.3184.
Results publication: PubMed 31390688Namsawang J, Eungpinichpong W, Vichiansiri R, Rattanathongkom S. Effects of the Short Foot Exercise With Neuromuscular Electrical Stimulation on Navicular Height in Flexible Flatfoot in Thailand: A Randomized Controlled Trial. J Prev Med Public Health. 2019 Jul;52(4):250-257. doi: 10.3961/jpmph.19.072. Epub 2019 Jul 14.
Results publication: PubMed 31962191Taddei UT, Matias AB, Ribeiro FIA, Bus SA, Sacco ICN. Effects of a foot strengthening program on foot muscle morphology and running mechanics: A proof-of-concept, single-blind randomized controlled trial. Phys Ther Sport. 2020 Mar;42:107-115. doi: 10.1016/j.ptsp.2020.01.007. Epub 2020 Jan 13.
Results publication: PubMed 24659509McKeon PO, Hertel J, Bramble D, Davis I. The foot core system: a new paradigm for understanding intrinsic foot muscle function. Br J Sports Med. 2015 Mar;49(5):290. doi: 10.1136/bjsports-2013-092690. Epub 2014 Mar 21.
Results publication: PubMed 27690528Gooding TM, Feger MA, Hart JM, Hertel J. Intrinsic Foot Muscle Activation During Specific Exercises: A T2 Time Magnetic Resonance Imaging Study. J Athl Train. 2016 Aug;51(8):644-650. doi: 10.4085/1062-6050-51.10.07. Epub 2016 Oct 3.
Results publication: PubMed 24149874Fourchet F, Kuitunen S, Girard O, Beard AJ, Millet GP. Effects of Combined Foot/Ankle Electromyostimulation and Resistance Training on the In-Shoe Plantar Pressure Patterns during Sprint in Young Athletes. J Sports Sci Med. 2011 Jun 1;10(2):292-300. eCollection 2011.
Results publication: PubMed 15531058Gaillet JC, Biraud JC, Bessou M, Bessou P. Modifications of baropodograms after transcutaneous electric stimulation of the abductor hallucis muscle in humans standing erect. Clin Biomech (Bristol). 2004 Dec;19(10):1066-9. doi: 10.1016/j.clinbiomech.2004.03.005.
Results publication: PubMed 14688773Fiolkowski P, Brunt D, Bishop M, Woo R, Horodyski M. Intrinsic pedal musculature support of the medial longitudinal arch: an electromyography study. J Foot Ankle Surg. 2003 Nov-Dec;42(6):327-33. doi: 10.1053/j.jfas.2003.10.003.
Results publication: PubMed 23181771Soysa A, Hiller C, Refshauge K, Burns J. Importance and challenges of measuring intrinsic foot muscle strength. J Foot Ankle Res. 2012 Nov 26;5(1):29. doi: 10.1186/1757-1146-5-29.
Results publication: PubMed 21864955Kelly LA, Kuitunen S, Racinais S, Cresswell AG. Recruitment of the plantar intrinsic foot muscles with increasing postural demand. Clin Biomech (Bristol). 2012 Jan;27(1):46-51. doi: 10.1016/j.clinbiomech.2011.07.013. Epub 2011 Aug 23.
Results publication: PubMed 25551151Kelly LA, Lichtwark G, Cresswell AG. Active regulation of longitudinal arch compression and recoil during walking and running. J R Soc Interface. 2015 Jan 6;12(102):20141076. doi: 10.1098/rsif.2014.1076.
Individual participant dataSharing planned: Undecided

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.

François Fourchet, PhD principal investigator

La Tour Hospital, Human Motion Lab

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

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 7 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 20 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.

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?

Change in Hallux flexion strength (time frame: All measures will be collected on both feet 1 week prior the treatment and 1 week after the last intervention session). 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 NCT05216692, which also lists 13 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 20 Apr 2022.