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Effectiveness of a Digital Prehabilitation Programme Before ACL Reconstruction

8. juni 2026 opdateret af: Alejandro Caña Pino

Effectiveness of a Digital Prehabilitation Programme Compared With Usual Care in Patients Awaiting Anterior Cruciate Ligament Reconstruction: A Randomised Controlled Superiority Trial

Background Prehabilitation prior to anterior cruciate ligament reconstruction (ACLR) has been shown to improve preoperative knee function, enhance quadriceps strength, and optimize postoperative recovery. However, access to supervised prehabilitation programmes remains limited. Digital health interventions may improve accessibility, adherence, and continuity of care.

Objective To determine whether a structured digital prehabilitation programme is more effective than usual care in improving quadriceps strength and functional outcomes after ACL reconstruction.

Methods/design This study is a single-centre, parallel-group, assessor-blinded randomised controlled trial. Adult participants scheduled for primary ACL reconstruction will be randomly allocated to either a usual care group or a digital prehabilitation group. The intervention group will complete a 4-week structured digital prehabilitation programme prior to surgery. Outcomes will be assessed preoperatively and up to 12 weeks postoperatively.

Expected Results The digital prehabilitation programme is expected to improve preoperative knee status and enhance postoperative quadriceps strength and functional recovery compared to usual care.

Studieoversigt

Status

Ikke rekrutterer endnu

Betingelser

Intervention / Behandling

Undersøgelsestype

Interventionel

Tilmelding (Anslået)

60

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiekontakt

  • Navn: João Paulo Sousa, PhD
  • Telefonnummer: 919662332
  • E-mail: jsousa@uevora.pt

Undersøgelse Kontakt Backup

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

  • Voksen

Tager imod sunde frivillige

Ingen

Beskrivelse

Inclusion Criteria:

  • Adults 18-55 years
  • Diagnosed ACL rupture
  • Scheduled for primary ACL reconstruction
  • Waiting ≥4 weeks before surgery

Exclusion Criteria:

  • Multiligament injury
  • Severe comorbidities
  • Previous ACL surgery same knee

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Forebyggelse
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Enkelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Aktiv komparator: Control Arm: Usual Care
Participants receive standard preoperative advice without a structured prehabilitation program
Andet: Usual Care
Participants in the control group will receive standard preoperative care, which may include general advice and routine clinical follow-up, but no structured prehabilitation programme.Participants will not receive a supervised or digital exercise intervention prior to surgery.
Eksperimentel: Experimental Arm: Digital Prehabilitation Programme. Knee Care@Home Programme

Participants will complete a structured 4-week digital prehabilitation programme prior to ACL reconstruction, including:

Range of motion exercises Strength training (quadriceps, hamstrings, hip musculature) Neuromuscular and balance training Patient education (surgery, recovery expectations) Lifestyle optimization (pain management, nutrition, emotional support)

Frequency: 3 sessions per week Duration: 10-20 minutes per session Delivery mode: Digital platform with guided sessions and remote supervision. Knee Care@Home Programme
Andet: Digital Prehabilitation Programme
Participants in the intervention group will undergo a structured 4-week digital prehabilitation programme prior to anterior cruciate ligament reconstruction.The programme includes:- Range of motion exercises targeting knee extension and flexion- Strength training focusing on quadriceps, hamstrings, and hip musculature- Neuromuscular and balance training- Patient education on surgical procedure, postoperative expectations, and recovery process- Lifestyle optimisation advice including pain management, nutrition, and emotional supportThe intervention will be delivered through a digital platform with guided exercise sessions and remote supervision.Frequency: 3 sessions per weekDuration: approximately 10-20 minutes per sessionThe programme aims to optimise preoperative knee function, improve quadriceps strength, and enhance postoperative recovery outcomes.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Quadriceps Isometric Strength
Tidsramme: 12 weeks postoperative
Maximum isometric quadriceps strength measured in seated position at 90° knee flexion. Three repetitions will be recorded, and the highest value will be used
12 weeks postoperative

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Knee Extension Range of Motion
Tidsramme: Baseline and preoperative (prior to surgery)
Passive knee extension will be measured in degrees using a standard goniometer. Full extension (0°) will be considered optimal preoperative status
Baseline and preoperative (prior to surgery)
Knee Pain Intensity
Tidsramme: Up to 12 weeks postoperative
Pain intensity will be assessed using a Visual Analogue Scale (VAS), ranging from 0 (no pain) to 100 (worst imaginable pain)
Up to 12 weeks postoperative
Knee Injury and Osteoarthritis Outcome Score (KOOS)
Tidsramme: Up to 12 weeks postoperative
Knee-related symptoms, pain, function in daily living, sport and recreation function, and knee-related quality of life will be assessed using the Knee Injury and Osteoarthritis Outcome Score (KOOS). Each subscale is scored from 0 to 100, where 0 represents extreme problems and 100 represents no problems (best outcome).
Up to 12 weeks postoperative
Single Leg Hop Distance
Tidsramme: Up to 12 weeks postoperative
Patients will perform a single-leg hop for maximum distance. The distance will be measured in centimetres
Up to 12 weeks postoperative
Pain Catastrophizing
Tidsramme: Up to 12 weeks postoperative
Pain-related catastrophic thinking will be assessed using the Pain Catastrophizing Scale (PCS). The total score ranges from 0 to 52, where higher scores indicate greater levels of pain catastrophizing (worse outcome).
Up to 12 weeks postoperative
DASS-21. Depression, Anxiety and Stress
Tidsramme: Up to 12 weeks postoperative
Psychological status will be assessed using the Depression Anxiety Stress Scales (DASS-21). The scale consists of three subscales (depression, anxiety, and stress), each ranging from 0 to 42 after score multiplication. Higher scores indicate greater emotional distress (worse outcome).
Up to 12 weeks postoperative

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Alejandro Caña Pino

Samarbejdspartnere

University of Extremadura
University of Évora

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Anslået)

15. september 2026

Primær færdiggørelse (Anslået)

15. oktober 2026

Studieafslutning (Anslået)

31. december 2026

Datoer for studieregistrering

Først indsendt

1. juni 2026

Først indsendt, der opfyldte QC-kriterier

8. juni 2026

Først opslået (Faktiske)

11. juni 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

11. juni 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

8. juni 2026

Sidst verificeret

1. juni 2026

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • 010626

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