- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT07653828
Evaluation of the Impact of Self-rehabilitation After Foot Surgery Via a Connected Application (M-First)
Hallux valgus is the most common forefoot deformity and primarily affects women. Surgical treatment involves an osteotomy of the first metatarsal to reduce the M1-M2 angle. Often, an osteotomy of the first phalanx of the big toe is performed in conjunction to reduce the M1-P1 angle.
Once the deformity has been corrected, the second objective is to restore the foot's function, particularly mobility and plantar flexion strength. To achieve this, rehabilitation is prescribed, but inconsistently due to the lack of clear guidelines and limited patient participation, especially outside of the physiotherapist's scheduled appointments.
Continuous passive range of motion exercises can accelerate the return to standard footwear and normal joint mobility. This study is based on the hypothesis that an application connected with rehabilitation exercises to be done outside of sessions with a physiotherapist reproduces this mechanism of continuous passive mobility. In this context, it is hoped that patients benefiting from self-rehabilitation of the foot via the connected application, in addition to traditional care with a physiotherapist, will achieve better postoperative mobility of the metatarsophalangeal joint of the hallux compared to traditional care with a physiotherapist in patients undergoing hallux valgus surgery, with an isolated procedure on the first ray.
The main objective is to compare the mobility of the metatarsophalangeal joint of the hallux 6 months after an operation for isolated hallux valgus by osteotomy in patients benefiting from optimized rehabilitation with a physiotherapist using a connected application compared to patients receiving standard care with a physiotherapist.
Studieoversigt
Status
Betingelser
Intervention / Behandling
Undersøgelsestype
Tilmelding (Anslået)
Fase
- Ikke anvendelig
Kontakter og lokationer
Studiekontakt
- Navn: Marie-Hélène Barba
- E-mail: mh.barba@ecten.eu
Undersøgelse Kontakt Backup
- Navn: Jean-François Oudet
- Telefonnummer: 0033683346567
- E-mail: jf.oudet@ecten.eu
Studiesteder
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Saint-Jean, Frankrig, 31240
- Rekruttering
- Clinique de l'Union
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Kontakt:
- François LINTZ, Dr
- Telefonnummer: 0033561378797
- E-mail: francois.lintz@clinique-union.fr
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Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
- Voksen
- Ældre voksen
Tager imod sunde frivillige
Beskrivelse
Inclusion Criteria:
- Age > 18 years and < 85 years,
- Patient, male or female, undergoing surgery for unilateral and isolated Hallux valgus with procedure of the 1st ray,
- First-line surgery,
- Persistent mobility of the metatarsophalangeal joint of the hallux,
- Patient in possession of a smartphone or tablet,
- Patient affiliated with or beneficiary of a social security scheme,
- Patient who has signed the free and informed consent.
Exclusion Criteria:
- Patient not having a smartphone or tablet,
- Rheumatoid foot,
- Hallux rigidus/MTP1 osteoarthritis,
- Gestures on the lateral rays
- Surgical or traumatic history influencing MTP1 mobility.
- Minors
- Adults under guardianship, curatorship or other legal protection, deprived of liberty by judicial decision or administrative;
- Pregnant, breastfeeding or parturient woman; - Hospitalized without consent
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Andet
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
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Eksperimentel: Patient with connected application
After hallux valgus surgery, this group of patient has a connected application to do some exercises at home in addition to physiotherapy sessions
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Primary surgery for hallux valgus
Different questionnaires : EFAS, EVA, EQ-5DL
Physiotherapy sessions twice a week for 10 weeks.
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Placebo komparator: Patients without connected application
After hallux valgus surgery, this group of patient has only physiotherapy sessions.
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Primary surgery for hallux valgus
Different questionnaires : EFAS, EVA, EQ-5DL
Physiotherapy sessions twice a week for 10 weeks.
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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Mobility of the metatarsophalangeal joint of the hallux
Tidsramme: 6 months
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Mobility of the metatarsophalangeal joint of the hallux is measured by the MTP1 angle (FD + FP), which will be clinically assessed using a goniometer.
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6 months
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Samarbejdspartnere og efterforskere
Datoer for undersøgelser
Studer store datoer
Studiestart (Faktiske)
Primær færdiggørelse (Anslået)
Studieafslutning (Anslået)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Faktiske)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- 2018-A03349-46
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