Recruiting

ACLR Rehabilitation

Sponsor:

HealthPartners Institute

Code:

NCT06991192

Conditions

Anterior Cruciate Ligament Reconstruction Rehabilitation

Eligibility Criteria

Sex: All

Age: 15 - 21

Healthy Volunteers: Not accepted

Interventions

Rehabilitation with Exercise and Psychological Support (REPS)

Study Details

Brief summary:

The purpose of this study is to examine ACLR Rehabilitation with Exercise and Psychological Support (REPS), comparing two approaches for providing psychological support along with exercise during ACL reconstruction rehabilitation. In one group, physical therapists have received training that may boost emotional support during rehabilitation. In the other group, physical therapists will not have the training. Both groups will get similar exercises and participate in the same testing. Both groups will also watch short videos during rehabilitation that are specific to their group. Participants will not know to which group they are assigned until the end of the study. Participation will attend a total of four study visits over the course of 6 months, including 1 visit before the surgery and 3 visits during follow-up.

Conditions

Anterior Cruciate Ligament Reconstruction Rehabilitation

Study ID

NCT06991192

Start date

May 1, 2025

Status verified date

May, 2026

Completion date

Aug 31, 2027

Anticipated

Primary completion date

Nov 30, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 15 - 21

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Age 15 to 21 years at the time of surgery;
  • Pre-injury Tegner Activity Rating60 ≥ 5 (5=recreational sports, 10=elite sports);
  • Sports participation at least 100 hours/year prior to injury;
  • Intent to resume a pre-injury sport that requires cutting, jumping, or pivoting;
  • ACL reconstruction performed ≤ 6 months from injury;
  • ACL reconstruction performed with bone-patellar tendon-bone autograft or quadriceps tendon autograft; and
  • Able to complete rehabilitation at one of the 4 participating TRIA locations.

Exclusion Criteria:

  • Previous ACL injury or surgery to either limb;
  • Concomitant ligamentous injury > Grade II or requiring surgery; and
  • Surgical procedure to articular cartilage requiring non-weight-bearing after surgery.

Study Design

Enrollment

60 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

no intervention: Standard Rehabilitation

TRIA rehabilitation protocols for ACL reconstruction with bone-patellar tendon-bone autograft or ACL reconstruction with meniscal repair will be used for prescribing exercise. Physical therapists may use adjunctive modalities such as neuromuscular electrical stimulation, blood flow restriction, manual therapy, and cryotherapy at their discretion. Exercise videos prescribed to study participants will be housed in an individual online account per standard clinical procedure (MedBridge, Bellevue, WA).

experimental: Psychological Support (REPS)

Study participants in Rehabilitation with Exercise and Psychological Support (REPS) will receive the standard rehabilitation treatment AND psychological support through a combination of PT training and patient training videos.

Interventions

Rehabilitation with Exercise and Psychological Support (REPS)

Rehabilitation with Exercise and Psychological Support (REPS) is a rehabilitation approach that integrates exercise with psychological support provided by physical therapist and patient training videos.

Primary outcome measure

  • ACL Return to Sport after Injury (ACL-RSI) [ Time Frame: Pre-surgery (baseline), prior to first post-surgical rehabilitation visit , 3-months post-surgery, 6-months post-surgery ]
  • International Knee Documentation Committee (IKDC) Subjective Form [ Time Frame: Pre-surgery (baseline), prior to first post-surgical rehabilitation visit , 3-months post-surgery, 6-months post-surgery ]

Central Contacts and Locations

Central contacts

TRIA Research

952-806-5603TRIAResearch@tria.com

Locations

TRIA

Recruiting

Bloomington, Minnesota, United States, 55431

Contacts

Andrea Lange

952-806-5603TRIAResearch@tria.com

More Information

Sponsor

HealthPartners Institute

Last update posted

May 5, 2026

Last verified

May, 2026

Keywords

  • ACL Reconstruction
  • Anterior Cruciate Ligament
  • Rehabilitation
  • Psychological

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by HealthPartners Institute on 2026-05-05.