NCT06755398

Brief Summary

The aim of this study is to investigate the effects of cognitive-based neuromuscular exercises on increased reaction time, decreased joint position sense, reduced proprioceptive force sense, and balance problems in individuals who have undergone surgery following anterior cruciate ligament (ACL) injuries. With the results obtained from the study, the investigators aim to provide a different perspective on rehabilitation methods applied after ACL reconstruction and contribute to the literature with objective and evidence-based information regarding the effects of cognitive-based neuromuscular exercises on sensorimotor, neuromuscular, and proprioceptive senses.

Trial Health

55
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
28

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jun 2024

Geographic Reach
1 country

1 active site

Status
enrolling by invitation

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 20, 2024

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

December 18, 2024

Completed
14 days until next milestone

First Posted

Study publicly available on registry

January 1, 2025

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2025

Completed
Last Updated

January 1, 2025

Status Verified

June 1, 2024

Enrollment Period

1.5 years

First QC Date

December 18, 2024

Last Update Submit

December 24, 2024

Conditions

Keywords

ACL ruptureCocnitive taskProprioceptionDual Task

Outcome Measures

Primary Outcomes (1)

  • The Effect of an 8-Week Cognitive-Based Neuromuscular Exercise Program on Lower Extremity Reaction Time

    This study evaluates lower extremity reaction time in individuals with anterior cruciate ligament (ACL) injuries using the FITLIGHT Corp system. Participants will deactivate randomly illuminated lights with their lower extremities. The system's wireless sensor discs will be placed according to each participant's leg length to minimize balance-related factors. Five lights will be arranged in a semicircular pattern at 45-degree intervals. Reaction time will be measured under three conditions: baseline, cognitive task, and motor task. In the baseline condition, participants will complete a 30-second practice trial followed by a 1-minute test trial. During the cognitive task, participants will count backward from 600 by fives while deactivating the lights. In the motor task, they will toss and catch a ball with their dominant hand while performing the light-deactivation task. The average reaction time in seconds will be recorded for both the injured and uninjured limbs.

    8 week

Study Arms (2)

Standard treatment group

SHAM COMPARATOR

The protocol developed by the Royal Dutch Society for Physical Therapy (KNGF) will be applied following anterior cruciate ligament (ACL) surgery.

Other: Exercise

experimental group

EXPERIMENTAL

During the exercises based on the protocol developed by the Royal Dutch Society for Physical Therapy (KNGF) following anterior cruciate ligament (ACL) surgery, additional cognitive tasks will be assigned to the patients.

Other: Exercise

Interventions

During the exercises based on the protocol developed by the Royal Dutch Society for Physical Therapy (KNGF) following anterior cruciate ligament (ACL) surgery, additional cognitive tasks will be assigned to the patients.

Also known as: dual task exercises, cognitive exercises
Standard treatment group

Eligibility Criteria

Age20 Years - 40 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Having sustained a unilateral isolated anterior cruciate ligament injury,
  • Having undergone anterior cruciate ligament reconstruction using a hamstring graft by a surgeon at least 8 weeks ago,
  • Having completed the early phase of the postoperative criterion-based rehabilitation protocol and met the criteria for progression to the intermediate phase of the rehabilitation program (1- pain between 0-2 on the numeric pain scale, 2- no effusion in the knee, 3- no limitation in passive knee extension, 4- passive knee flexion of at least 120°, 5- full quadriceps activation (patient able to perform 10 repetitions of a single-leg raise exercise), and 6- normalized gait pattern without assistance).

You may not qualify if:

  • Having a partial ACL tear,
  • Having sustained bilateral ACL injuries,
  • Having additional injuries accompanying the ACL injury,
  • Having undergone ACL revision surgery,
  • Having a history of complex knee surgery,
  • Having any neurological, orthopedic, or systemic disease that may contraindicate exercise.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Antalya Bilim University

Antalya, 07100, Turkey (Türkiye)

Location

Related Publications (7)

  • Elabd OM, Elabd AM. Functional outcomes of a criterion-based rehabilitation protocol for anterior cruciate ligament reconstruction in amateur athletes: A randomised clinical trial. J Bodyw Mov Ther. 2023 Jul;35:7-13. doi: 10.1016/j.jbmt.2023.04.037. Epub 2023 Apr 17.

    PMID: 37330806BACKGROUND
  • Buckthorpe M, Della Villa F. Optimising the 'Mid-Stage' Training and Testing Process After ACL Reconstruction. Sports Med. 2020 Apr;50(4):657-678. doi: 10.1007/s40279-019-01222-6.

    PMID: 31782065BACKGROUND
  • Elabd OM, Alghadir AH, Ibrahim AR, Hasan S, Rizvi MR, Sharma A, Iqbal A, Elabd AM. Functional outcomes of accelerated rehabilitation protocol for anterior cruciate ligament reconstruction in amateur athletes: a randomized clinical trial. J Rehabil Med. 2024 Feb 22;56:jrm12296. doi: 10.2340/jrm.v56.12296.

    PMID: 38385715BACKGROUND
  • Li D, Zhang Q, Liu X, Chen C, Lu J, Ye D, Li Y, Wang W, Shen M. Effect of water-based walking exercise on rehabilitation of patients following ACL reconstruction: a prospective, randomised, single-blind clinical trial. Physiotherapy. 2022 Jun;115:18-26. doi: 10.1016/j.physio.2021.11.003. Epub 2021 Dec 1.

    PMID: 35101723BACKGROUND
  • Kiele D, Solianik R. Four-Week Application of Kinesiotaping Improves Proprioception, Strength, and Balance in Individuals With Complete Anterior Cruciate Ligament Rupture. J Strength Cond Res. 2023 Jan 1;37(1):213-219. doi: 10.1519/JSC.0000000000004245. Epub 2022 Apr 13.

    PMID: 35438677BACKGROUND
  • Buckthorpe M, Gokeler A, Herrington L, Hughes M, Grassi A, Wadey R, Patterson S, Compagnin A, La Rosa G, Della Villa F. Optimising the Early-Stage Rehabilitation Process Post-ACL Reconstruction. Sports Med. 2024 Jan;54(1):49-72. doi: 10.1007/s40279-023-01934-w. Epub 2023 Oct 3.

    PMID: 37787846BACKGROUND
  • Leal J, Mirza B, Davies L, Fletcher H, Stokes J, Cook JA, Price A, Beard DJ. Cost-effectiveness analysis of a pragmatic randomized trial evaluating surgical reconstruction versus rehabilitation in patients with long-standing anterior cruciate ligament injury. Bone Joint J. 2024 Jan 1;106-B(1):38-45. doi: 10.1302/0301-620X.106B1.BJJ-2023-0175.R1.

    PMID: 38160685BACKGROUND

MeSH Terms

Conditions

Anterior Cruciate Ligament Injuries

Interventions

Exercise

Condition Hierarchy (Ancestors)

Knee InjuriesLeg InjuriesWounds and Injuries

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • Ertugrul Demirdel, Associate professor

    Ankara Yildirim Beyazıt University

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Associate professor

Study Record Dates

First Submitted

December 18, 2024

First Posted

January 1, 2025

Study Start

June 20, 2024

Primary Completion

December 31, 2025

Study Completion

December 31, 2025

Last Updated

January 1, 2025

Record last verified: 2024-06

Data Sharing

IPD Sharing
Will not share

Under the Personal Data Protection Law, disclosing personal data outside of official authorities constitutes a criminal offense. Additionally, the results of the study do not involve personal information.

Locations