NCT07322497

Brief Summary

The goal of this clinical trial is to learn if using a phone app for exercises is as effective as working with a physical therapist before anterior cruciate ligament knee surgery. It will also check if exercising before surgery helps patients recover better compared to those who do not follow a specific exercise plan. The main questions it aims to answer are:

  • Does the phone app help patients improve their knee strength and movement as well as seeing a physical therapist?
  • Do patients who exercise before surgery have a better recovery after surgery than those who do not? Researchers will compare the phone app group to a physical therapist group and a group with no specific exercise plan to see which method works best. Participants will:
  • Follow an exercise plan for 4 weeks before their surgery (either using the app, with a therapist, or no specific plan).
  • Visit the clinic for check-ups before starting the exercises, right before the surgery, and 6 months after the surgery.
  • Complete simple tests and surveys to measure their knee health.

Trial Health

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Monitor

Trial Health Score

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

Enrollment
66

participants targeted

Target at P50-P75 for not_applicable

Timeline
20mo left

Started Dec 2025

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

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

Study Progress18%
Dec 2025Dec 2027

First Submitted

Initial submission to the registry

December 22, 2025

Completed
7 days until next milestone

Study Start

First participant enrolled

December 29, 2025

Completed
9 days until next milestone

First Posted

Study publicly available on registry

January 7, 2026

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 29, 2026

Expected
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 29, 2027

Last Updated

January 7, 2026

Status Verified

December 1, 2025

Enrollment Period

1 year

First QC Date

December 22, 2025

Last Update Submit

December 22, 2025

Conditions

Keywords

Preoperative RehabilitationACL ReconstrucitonPrehabilitationMobile ApplicationTelerehabiltiation

Outcome Measures

Primary Outcomes (2)

  • Isometric Quadriceps Muscle Strength

    Muscle strength will be measured using a hand-held dynamometer (Newton). Measurements will be taken at 30 and 70 degrees of knee flexion. The highest value of 3 trials will be recorded.

    Baseline, Preoperative (Week 4), and Postoperative (Month 6)

  • Isometric Hamstring Muscle Strength

    Muscle strength will be measured using a hand-held dynamometer (Newton) at 35 and 60 degrees of flexion

    Baseline, Preoperative (Week 4), and Postoperative (Month 6).

Secondary Outcomes (7)

  • IKDC 2000 Subjective Knee Evaluation Form

    Baseline, Preoperative (Week 4), and Postoperative (Month 6).

  • Knee Range of Motion (ROM)

    Baseline, Preoperative (Week 4), and Postoperative (Month 6).

  • Single Leg Hop Test (Limb Symmetry Index)

    Baseline, Preoperative (Week 4), and Postoperative (Month 6).

  • Star Excursion Balance Test (SEBT)

    Baseline, Preoperative (Week 4), and Postoperative (Month 6).

  • Active Joint Position Sense

    Baseline, Preoperative (Week 4), and Postoperative (Month 6).

  • +2 more secondary outcomes

Study Arms (3)

Video Based App Group

EXPERIMENTAL

Participants will receive a progressive, unsupervised exercise program via a mobile application for 4 weeks prior to surgery. The app provides video guidance, reminders, and compliance tracking.

Behavioral: Mobile App Exercise Program

Supervised Rehabilitation Group

ACTIVE COMPARATOR

Participants will undergo a supervised exercise program with a physiotherapist (3 days/week) for 4 weeks prior to surgery. The protocol is identical to the app group.

Behavioral: Supervised Physiotherapy

Control Group

NO INTERVENTION

Participants will receive standard care and will not receive a specific preoperative exercise prescription.

Interventions

A 4-week progressive home exercise program delivered via a smartphone app. It focuses on range of motion, edema control, strengthening, and balance exercises.

Video Based App Group

A 4-week in-clinic exercise program supervised by a physiotherapist, including the same exercises as the app group

Supervised Rehabilitation Group

Eligibility Criteria

Age18 Years - 45 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Patients with a diagnosed unilateral Anterior Cruciate Ligament (ACL) rupture
  • Patients scheduled for ACL reconstruction surgery.
  • Age between 18 and 45 years.
  • Patients willing to participate and sign the informed consent form.

You may not qualify if:

  • Patients with multiple ligament injuries (e.g., combined ACL and PCL/MCL injury).
  • Patients with bilateral ACL injuries.
  • Presence of accompanying fractures around the knee joint.
  • Presence of active infection.
  • Patients who refuse surgery or withdraw consent.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kartal Dr. Lütfi Kırdar City Hospital

Istanbul, Kartal, 34865, Turkey (Türkiye)

Location

MeSH Terms

Conditions

RuptureWounds and Injuries

Central Study Contacts

Ömer Hekim, PT, MSc

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Physiotherapist, PhD Candidate

Study Record Dates

First Submitted

December 22, 2025

First Posted

January 7, 2026

Study Start

December 29, 2025

Primary Completion (Estimated)

December 29, 2026

Study Completion (Estimated)

December 29, 2027

Last Updated

January 7, 2026

Record last verified: 2025-12

Data Sharing

IPD Sharing
Will not share

Locations