NCT07643480

Brief Summary

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.

Trial Health

65
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
4mo left

Started Sep 2026

Shorter than P25 for not_applicable

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 1, 2026

Completed
10 days until next milestone

First Posted

Study publicly available on registry

June 11, 2026

Completed
3 months until next milestone

Study Start

First participant enrolled

September 15, 2026

Expected
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 15, 2026

3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2026

Last Updated

June 11, 2026

Status Verified

June 1, 2026

Enrollment Period

1 month

First QC Date

June 1, 2026

Last Update Submit

June 8, 2026

Conditions

Keywords

Anterior Cruciate LigamentACL ReconstructionPrehabilitationDigital HealthExercise TherapyTelerehabilitationQuadriceps StrengthKnee Function

Outcome Measures

Primary Outcomes (1)

  • Quadriceps Isometric Strength

    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

Secondary Outcomes (6)

  • Knee Extension Range of Motion

    Baseline and preoperative (prior to surgery)

  • Knee Pain Intensity

    Up to 12 weeks postoperative

  • Knee Injury and Osteoarthritis Outcome Score (KOOS)

    Up to 12 weeks postoperative

  • Single Leg Hop Distance

    Up to 12 weeks postoperative

  • Pain Catastrophizing

    Up to 12 weeks postoperative

  • +1 more secondary outcomes

Study Arms (2)

Control Arm: Usual Care

ACTIVE COMPARATOR

Participants receive standard preoperative advice without a structured prehabilitation program

Other: Usual Care

Experimental Arm: Digital Prehabilitation Programme. Knee Care@Home Programme

EXPERIMENTAL

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

Other: Digital Prehabilitation Programme

Interventions

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.

Experimental Arm: Digital Prehabilitation Programme. Knee Care@Home Programme

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.

Control Arm: Usual Care

Eligibility Criteria

Age18 Years - 55 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Anterior Cruciate Ligament Injuries

Condition Hierarchy (Ancestors)

Knee InjuriesLeg InjuriesWounds and Injuries

Central Study Contacts

Alejandro Caña Pino, PhD

CONTACT

João Paulo Sousa, PhD

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Investigator

Study Record Dates

First Submitted

June 1, 2026

First Posted

June 11, 2026

Study Start (Estimated)

September 15, 2026

Primary Completion (Estimated)

October 15, 2026

Study Completion (Estimated)

December 31, 2026

Last Updated

June 11, 2026

Record last verified: 2026-06