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Spastic FootPEPSNCT06138418

Spasticity Multidisciplinary Management : QoL and Physical Activity Measurement With Connected Health Devices (PEPS)

A study testing Neurotomy in people with Spastic Foot, run by University Hospital, Angers at 1 site in France.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial summary

PEPS is a 18 months prospective bicentric study on 30 patients with spastic foot. The main objective is to evaluate the mean daily gait perimeter modifications mesured by connected watch, 6 months after spastic equinus foot surgery versus before this surgery. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Spastic Foot
What is being tested?
Neurotomy
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
2 participants
Where
1 siteFrance
Study dates
22 Feb 2024to 24 Jul 2025
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 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Over 18 years old
  • Walking patient
  • Spastic foot surgery indication
  • Consent form ok
  • Patient with iOS or Android mobile phone

Who cannot join

  • Previous spastic surgery
  • Psychiatric disease
  • Pregnancy

Trial locations and contacts

1 site in 1 country.

France1 site

  • Angers University Hospital

    Angers, 44933

Other trials in France

About this study

PEPS is a 18 months prospective bicentric study on 30 patients with spastic foot. The main objective is to evaluate the mean daily gait perimeter modifications mesured by connected watch, 6 months after spastic equinus foot surgery versus before this surgery. Investigator will lend a connected watch during the first consultation, and the patient will use it during 10 days in order to collect his mean daily gait perimeter. A lot of other tests will be realised in order to caracterize the clinical picture of each patient. After patients will be operated and all caracteristics of the surgery will be collected. Finally, at 6 months appointment, investigator will do the same analysis than first appointment in order to comparate the data for functional prognosis.

Read the detailed description

The study is proposed to eligible patients after a pluridisciplinar specialised appointment in the Neurosurgery ward, realised by a neurosurgeon, an orthopedist and a PRM physician. After spastic equinus foot diagnosis needed surgery et after patient's consent to the surgery, investigator will proposed to patient to participate at our study.

Before surgery, demographic datas, spasticity clinical datas, clinical examination (Ashworth and Penn scale), past treatments are collected. Other investigations are realised : FIM, NFAC, Rivermead mobility index, Lower extremity functional scale, SF36, EQ5D. Gait perimeter are collected by the connected watch, and also with a 10 meters test, the gait perimeter on flat and level ground which is unencumbered by any obstacles, Gaitrite evaluation. Patient will conserved the connected watch during all the study duration.

Peroperative datas are collected for each pateints with 3 times. First, before surgery, investigator collect joint range of motion under general anesthesia but without curarization. Second, during surgery, the surgical technique is described, with which nerves and which muscles are treated. Finally, after surgery, investigator will de novo collect joint ranges with the same clinical conditions.

At 6 months appointment, routine datas are collected (surgical complications, clinical examination) and also the notified investifations (FIM, NFAC ...), clinical investigations (Gaitrite, connected watch datas ...)

Conditions
Spastic Foot
Being tested
Neurotomy
Keywords
spasticity, spastic foot, podometer, neurosurgery
Medical subject headings
Muscle Spasticity

What participants receive

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

  • NeurotomyProcedure or surgery

    Also called Tenotomy

    Surgical treatment of spastic foot

Study groups in NCT06138418
Study groupRoleWhat they receive
Longitudinal cohort studyExperimentalLongitudinal cohort study
Receives: Procedure: Neurotomy

What is being measured

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

  1. Walking perimeter changes measured by a connected watch before vs after spastic foot surgery

    Evaluate daily walking perimeter measure measured during 10 days with a connected watch in operated patients between 6 months appointment and pre surgical appointment. Use of appariated Student t test and Spearman test

    Measured: 18 months

Secondary outcomes (9)

  1. Diagnostic performance of walking perimeter measure

    Spearman test to evaluate diagnostic performance of connected watch datas with clinical datas (Gaitrite, 10 m test ...)

    Measured: 18 months

  2. Quality of measure

    descriptives statistics on percentage of days when connected watch used

    Measured: 18 months

  3. Quality of measure

    descriptives statistics on percentage of loss of watch

    Measured: 18 months

  4. Quality of measure

    descriptives statistics on evaluation of acceptability of connected watch.

    Measured: 18 months

  5. Walking perimeter improvement delay after plaster cast remove

    daily mean after plaster cast remove in which walking perimeter is increasing for 50%

    Measured: 18 months

  6. SF-36 Quality of life evolution before vs after surgery

    Student t test to evaluate the QOL modications

    Measured: 18 months

  7. EQ5D Quality of life evolution before vs after surgery

    Student t test to evaluate the QOL modications

    Measured: 18 months

  8. Rivermead Quality of life evolution before vs after surgery

    Student t test to evaluate the QOL modications

    Measured: 18 months

  9. LEFS Quality of life evolution before vs after surgery

    Student t test to evaluate the QOL modications

    Measured: 18 months

Timeline

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

  1. First posted18 Nov 2023
  2. Study start22 Feb 2024
  3. Primary completion24 Jul 2025
  4. Study completion24 Jul 2025

Why it stopped: inclusion rate too low

Resources

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
Other
Allocation
Not applicable
Intervention model
Single group
Model description
Longitudinal evaluation waking ability within activity devices
Masking
None (open label)
Enrolment
2 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06138418
Sponsor's protocol ID
2022-A01629-34
Acronym
PEPS
Status last verified
Mar 2026
First submitted
5 Jul 2023
Last updated
6 Apr 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Sheean G. The pathophysiology of spasticity. Eur J Neurol. 2002 May;9 Suppl 1:3-9; dicussion 53-61. doi: 10.1046/j.1468-1331.2002.0090s1003.x.

    PubMed 11918643

  • Wallace D, Duncan PW, Lai SM. Comparison of the responsiveness of the Barthel Index and the motor component of the Functional Independence Measure in stroke: the impact of using different methods for measuring responsiveness. J Clin Epidemiol. 2002 Sep;55(9):922-8. doi: 10.1016/s0895-4356(02)00410-9.

    PubMed 12393081

  • Milligan J, Ryan K, Lee J. Demythifier la spasticite en premiere ligne. Can Fam Physician. 2019 Oct;65(10):e422-e428. French.

    PubMed 31604751

  • Nikamp CD, Buurke JH, van der Palen J, Hermens HJ, Rietman JS. Early or delayed provision of an ankle-foot orthosis in patients with acute and subacute stroke: a randomized controlled trial. Clin Rehabil. 2017 Jun;31(6):798-808. doi: 10.1177/0269215516658337. Epub 2016 Jul 7.

    PubMed 27390153

  • Bohannon RW, Smith MB. Interrater reliability of a modified Ashworth scale of muscle spasticity. Phys Ther. 1987 Feb;67(2):206-7. doi: 10.1093/ptj/67.2.206.

    PubMed 3809245

  • Trompetto C, Marinelli L, Mori L, Pelosin E, Curra A, Molfetta L, Abbruzzese G. Pathophysiology of spasticity: implications for neurorehabilitation. Biomed Res Int. 2014;2014:354906. doi: 10.1155/2014/354906. Epub 2014 Oct 30.

    PubMed 25530960

  • Sankaranarayan H, Gupta A, Khanna M, Taly AB, Thennarasu K. Role of ankle foot orthosis in improving locomotion and functional recovery in patients with stroke: A prospective rehabilitation study. J Neurosci Rural Pract. 2016 Oct-Dec;7(4):544-549. doi: 10.4103/0976-3147.185507.

    PubMed 27695234

  • Deltombe T, Gustin T. Selective tibial neurotomy in the treatment of spastic equinovarus foot in hemiplegic patients: a 2-year longitudinal follow-up of 30 cases. Arch Phys Med Rehabil. 2010 Jul;91(7):1025-30. doi: 10.1016/j.apmr.2010.04.010.

    PubMed 20599040

  • King BW, Ruta DJ, Irwin TA. Spastic foot and ankle deformities: evaluation and treatment. Foot Ankle Clin. 2014 Mar;19(1):97-111. doi: 10.1016/j.fcl.2013.10.007.

    PubMed 24548513

  • Kidd D, Stewart G, Baldry J, Johnson J, Rossiter D, Petruckevitch A, Thompson AJ. The Functional Independence Measure: a comparative validity and reliability study. Disabil Rehabil. 1995 Jan;17(1):10-4. doi: 10.3109/09638289509166622.

    PubMed 7858276

  • Dones I, Nazzi V, Broggi G. The guidelines for the diagnosis and treatment of spasticity. J Neurosurg Sci. 2006 Dec;50(4):101-5.

    PubMed 17108887

  • Menz HB, Latt MD, Tiedemann A, Mun San Kwan M, Lord SR. Reliability of the GAITRite walkway system for the quantification of temporo-spatial parameters of gait in young and older people. Gait Posture. 2004 Aug;20(1):20-5. doi: 10.1016/S0966-6362(03)00068-7.

    PubMed 15196515

  • Rossier P, Wade DT. Validity and reliability comparison of 4 mobility measures in patients presenting with neurologic impairment. Arch Phys Med Rehabil. 2001 Jan;82(1):9-13. doi: 10.1053/apmr.2001.9396.

    PubMed 11239279

  • Rene F, Casimiro L, Tremblay M, Brosseau L, Lefebvre A, Beaudouin M, Belliveau V, Bergeron LP. Une version canadienne francaise du Lower Extremity Functional Scale (LEFS) : L'Echelle fonctionnelle des membres inferieurs (EFMI), partie I. Physiother Can. 2011 Spring;63(2):242-8. doi: 10.3138/ptc.2010-11F. Epub 2011 Apr 13. French.

    PubMed 22379265

  • Ferguson T, Rowlands AV, Olds T, Maher C. The validity of consumer-level, activity monitors in healthy adults worn in free-living conditions: a cross-sectional study. Int J Behav Nutr Phys Act. 2015 Mar 27;12:42. doi: 10.1186/s12966-015-0201-9.

    PubMed 25890168

Questions about this trial

What is this clinical trial studying?

A study testing Neurotomy in people with Spastic Foot, run by University Hospital, Angers at 1 site in France.

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 5 inclusion and 3 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: stopped early, as of the sponsor's last update on 6 Apr 2026. 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 France. 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 was stopped early (reason given: inclusion rate too low). Results are not available in the source record.

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?

Walking perimeter changes measured by a connected watch before vs after spastic foot surgery (time frame: 18 months). 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 NCT06138418, which also lists 16 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 6 Apr 2026.

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