Anterior Cruciate Ligament InjuryNCT07643480
Effectiveness of a Digital Prehabilitation Programme Before ACL Reconstruction
A study testing Digital Prehabilitation Programme in people with Anterior Cruciate Ligament Injury, run by Alejandro Caña Pino.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 55 years
- Conditions the study is for
- Anterior Cruciate Ligament Injury
- What is being tested?
- Digital Prehabilitation Programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- 15 Sep 2026to 31 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 55 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Adults 18-55 years
- Diagnosed ACL rupture
- Scheduled for primary ACL reconstruction
- Waiting ≥4 weeks before surgery
Who cannot join
- Multiligament injury
- Severe comorbidities
- Previous ACL surgery same knee
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: 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.
Read more
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.
- Conditions
- Anterior Cruciate Ligament Injury
- Being tested
- Digital Prehabilitation Programme, Usual Care
- Keywords
- Anterior Cruciate Ligament, ACL Reconstruction, Prehabilitation, Digital Health, Exercise Therapy, Telerehabilitation, Quadriceps Strength, Knee Function
- Medical subject headings
- Anterior Cruciate Ligament Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Digital Prehabilitation ProgrammeOther
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.
Usual CareOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Control Arm: Usual Care | Active comparator | Participants receive standard preoperative advice without a structured prehabilitation program Receives: 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 Receives: Other: Digital Prehabilitation Programme |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 12 weeks postoperative
Secondary outcomes (6)
Knee Extension Range of Motion
Passive knee extension will be measured in degrees using a standard goniometer. Full extension (0°) will be considered optimal preoperative status
Measured: Baseline and preoperative (prior to surgery)
Knee Pain Intensity
Pain intensity will be assessed using a Visual Analogue Scale (VAS), ranging from 0 (no pain) to 100 (worst imaginable pain)
Measured: Up to 12 weeks postoperative
Knee Injury and Osteoarthritis Outcome Score (KOOS)
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).
Measured: Up to 12 weeks postoperative
Single Leg Hop Distance
Patients will perform a single-leg hop for maximum distance. The distance will be measured in centimetres
Measured: Up to 12 weeks postoperative
Pain Catastrophizing
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).
Measured: Up to 12 weeks postoperative
DASS-21. Depression, Anxiety and Stress
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).
Measured: Up to 12 weeks postoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jun 2026
- Study start15 Sep 2026 (estimated)
- Primary completion15 Oct 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Anterior Cruciate Ligament InjuryStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Alejandro Caña Pino
- Sponsor type
- University, hospital or other
- Collaborators
- University of Extremadura, University of Évora
- Responsible party
- Sponsor-investigator, Alejandro Caña Pino, University of Extremadura
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07643480
- Sponsor's protocol ID
- 010626
- Status last verified
- Jun 2026
- First submitted
- 1 Jun 2026
- Last updated
- 11 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of a Digital Prehabilitation Programme Compared With Usual Care in Patients Awaiting Anterior Cruciate Ligament Reconstruction: A Randomised Controlled Superiority Trial
- ClinicalTrials.gov ID
- NCT07643480
- Acronym / sponsor ID
- 010626
- Conditions
- Anterior Cruciate Ligament Injury
- Keywords
- Anterior Cruciate Ligament, ACL Reconstruction, Prehabilitation, Digital Health, Exercise Therapy, Telerehabilitation, Quadriceps Strength, Knee Function
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Alejandro Caña PinoUniversity, hospital or other
- Collaborators
- University of Extremadura, University of Évora
- Study start
- 15 Sep 2026 (estimated)
- Primary completion
- 15 Oct 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 11 Jun 2026 (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.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control Arm: Usual Care | Active comparator | Other: Usual CareParticipants receive standard preoperative advice without a structured prehabilitation program |
| Experimental Arm: Digital Prehabilitation Programme. Knee Care@Home Programme | Experimental | Other: Digital Prehabilitation ProgrammeParticipants 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 |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Adults 18-55 years
- Diagnosed ACL rupture
- Scheduled for primary ACL reconstruction
- Waiting ≥4 weeks before surgery
Key exclusion criteria (3 listed)
- Multiligament injury
- Severe comorbidities
- Previous ACL surgery same knee
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 |
|---|---|---|
| Digital Prehabilitation ProgrammeParticipants 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. | Other | Experimental Arm: Digital Prehabilitation Programme. Knee Care@Home Programme |
| Usual CareParticipants 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. | Other | Control Arm: Usual Care |
Primary outcome
Quadriceps Isometric Strength
Time frame: 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
6 secondary outcomes
Knee Extension Range of Motion
Time frame: Baseline and preoperative (prior to surgery)
Knee Pain Intensity
Time frame: Up to 12 weeks postoperative
Knee Injury and Osteoarthritis Outcome Score (KOOS)
Time frame: Up to 12 weeks postoperative
Single Leg Hop Distance
Time frame: Up to 12 weeks postoperative
Pain Catastrophizing
Time frame: Up to 12 weeks postoperative
DASS-21. Depression, Anxiety and Stress
Time frame: Up to 12 weeks postoperative
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jun 2026.
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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.
Questions about this trial
What is this clinical trial studying?
A study testing Digital Prehabilitation Programme in people with Anterior Cruciate Ligament Injury, run by Alejandro Caña Pino.
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 4 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: opening soon, as of the sponsor's last update on 11 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Alejandro Caña Pino, PhD (927251220, alejandrocp@unex.es), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Quadriceps Isometric Strength (time frame: 12 weeks postoperative). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 11 Jun 2026.