- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06845150
Combined Compared to Sequential Cognitive and Physical Training in Anterior Cruciate Ligament Reconstructed Individuals (DUACL)
Dual-Task Training in an Immersive Environment Compared to Single Task Training in Anterior Cruciate Ligament Reconstructed Individuals
The goal of this clinical trial is to investigate changes in cognitive and physical performance after 10 weeks of dual or single task training in anterior cruciate ligament (ACL) reconstructed individuals. The main questions it aims to answer are:
- Does cognitive performance in ACL reconstructed individuals change after multiple training sessions incorporating single versus dual-task?
- Does physical performance and intrinsic motivation for training change over the course of 10 weeks when performing single versus dual-task training sessions?
- What movement patterns do ACL reconstructed individuals show during a dual-task training in an immersive environment?
Researchers will compare a combined dual-task training (combined physical and cognitive training) to a single task training (physical and cognitive training separately) to see if there are changes on cognitive performance depending on the training type.
Participants will:
- Perform dual-task or single task training twice per week for 10 weeks
- Visit the clinic before and after the training period for tests
- Visit the movement laboratory once for analysis of movement patterns
Study Overview
Status
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Winterthur, Switzerland, 8000
- KSW Kantonsspital Winterthur
-
Winterthur, Switzerland, 8000
- ZHAW Zurich University of Applied Sciences
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- 18-40 years old
- At least 6 months after ACL injury
- Surgically reconstructed ACL
- At least 2 hours of sports participation before the injury
- Written consent of the attending surgeon to perform intensified training methods including one-legged jumps at 6 months after surgery after the first visit
- Ability to give informed consent as documented by signature
- Ability to understand instructions in German or English
- BMI < 28 kg/m^2
- Availability to take part in at least 70% of all training sessions
Exclusion Criteria:
- Surgery on the contralateral leg during the last 12 months
- Acute or chronic musculoskeletal, neurological, or cardiopulmonary disorders
- Unadjusted vision problems
- Concussion during the last 6 months
- Pregnancy
- Breastfeeding
- Amputation
- Inflammatory pain or swelling during exercising
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Dual-task training
|
Combined simultaneous physical and cognitive training in an immersive environment
|
|
Active Comparator: Single task training
|
Sequential cognitive and then physical training
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Interference
Time Frame: Baseline, after 5 weeks of training, after 10 weeks of training
|
Measured by the difference in reaction time of congruent and incongruent stimuli of the Flanker task.
|
Baseline, after 5 weeks of training, after 10 weeks of training
|
|
Response inhibition
Time Frame: Baseline, after 5 weeks of training, after 10 weeks of training
|
Measured by the accuracy of Go/No-Go-stimuli
|
Baseline, after 5 weeks of training, after 10 weeks of training
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Jumping performance - contact time
Time Frame: Baseline and after 10 weeks of training
|
Contact time during jumping on force plates.
|
Baseline and after 10 weeks of training
|
|
Jumping performance - peak force
Time Frame: Baseline and after 10 weeks of training
|
Peak force during jumping on force plates.
|
Baseline and after 10 weeks of training
|
|
Strength
Time Frame: Baseline and after 10 weeks of training
|
Peak force of hamstring, quadriceps, hip abduction, and hip adduction
|
Baseline and after 10 weeks of training
|
|
Intrinsic motivation
Time Frame: At the end of each training session (2x/week for 10 weeks)
|
German version of the short scale for intrinsic motivation (Kurzskala Intrinsische Motivation).
For each of the 12 items there is a 5-point Likert-Scale resulting in values of 0-4.
Therefore, the total score ranges from 0 to 48.
The higher the score, the higher the intrinsic motivation.
|
At the end of each training session (2x/week for 10 weeks)
|
|
Kinematics and kinetics of the lower extremities
Time Frame: During dual-task training in an immersive environment
|
Hip, knee, and ankle angles and moments and ground reaction forces
|
During dual-task training in an immersive environment
|
|
Kinematics and kinetics of the lower extremities
Time Frame: Baseline and after 10 weeks of training
|
Ground reaction forces, angles and moments of hip, knee, and ankle during functional tasks
|
Baseline and after 10 weeks of training
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Kujala
Time Frame: Baseline and after 10 weeks of training
|
The German version of the 13-item Kujala questionnaire will be used for assessment of anterior knee pain.
Questions involve ability to do several activities and symptoms of patients.
All scores of the 13 items are summed up to give a total score ranging from 0 to 100.
High scores indicate a good outcome.
|
Baseline and after 10 weeks of training
|
|
ACL-Return to Sport after Injury Scale
Time Frame: Baseline and after 10 weeks of training
|
The German version of the ACL-RSI will be used.
The ACL-Return to Sport after Injury Scales includes 12 items which are each answered on a Likert-scale from 0 to 100.
For the total score, individual scores of each item are added and subsequently divided by the numer of questions.
Hence total score ranges from 0 to 120.
High scores indicate a positive psychological evaluation.
|
Baseline and after 10 weeks of training
|
|
Tegner Activity Scale
Time Frame: Baseline and after 10 weeks of training
|
The German version of the Tegner Activity Scale including 11 different stages will be used.
Each stage includes activities in sports and work of patients after ACL injury.
Stages range from 0 to 10.
|
Baseline and after 10 weeks of training
|
|
Socio-demographic data
Time Frame: Baseline
|
Sex, age, time since ACL reconstruction, injury history
|
Baseline
|
|
Subjective Cognitive Load
Time Frame: At the end of each training session (2x/week for 10 weeks)
|
Measured by the NASA-TLX questionnaire
|
At the end of each training session (2x/week for 10 weeks)
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- DUACL
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Anterior Cruciate Ligament Reconstruction Rehabilitation
-
Federal University of Health Science of Porto AlegreRecruitingAnterior Cruciate Ligament Reconstruction | Anterior Cruciate Ligament Reconstruction RehabilitationBrazil
-
Federal University of Health Science of Porto AlegreRecruitingAnterior Cruciate Ligament Reconstruction | Anterior Cruciate Ligament Reconstruction RehabilitationBrazil
-
Egas Moniz - Cooperativa de Ensino Superior, CRLRecruitingAnterior Cruciate Ligament Reconstruction | Athlete | Anterior Cruciate Ligament Reconstruction RehabilitationPortugal
-
Hacettepe UniversityRecruitingAnterior Cruciate Ligament Reconstruction Rehabilitation | Strength Outcomes | Anterior Cruciate Ligament (ACL) Reconstruction SurgeryTurkey (Türkiye)
-
University of Sao Paulo General HospitalUnknownAnterior Cruciate Ligament Reconstruction | Rehabilitation | Anterolateral Ligament ReconstructionBrazil
-
Richard Watson, PTCompletedMedial Patellar Femoral Ligament Reconstruction Rehabilitation | Anterior Cruciate Ligament Reconstruction RehabilitationUnited States
-
University of Mississippi Medical CenterRecruitingAnterior Cruciate Ligament Reconstruction RehabilitationUnited States
-
Biruni UniversityCompletedAnterior Cruciate Ligament Reconstruction RehabilitationTurkey (Türkiye)
-
Universidad de MurciaEnrolling by invitationAnterior Cruciate Ligament Reconstruction RehabilitationSpain
-
Universidad de MurciaRecruitingAnterior Cruciate Ligament Reconstruction RehabilitationSpain
Clinical Trials on Dual-task training
-
Sezen Karaborklu ArgutRecruitingPostural Balance | Healthy Older Adults | Dual Task Exercises in Elderly People | Dual Task CostTurkey (Türkiye)
-
Foundation University IslamabadCompletedCognitive Dysfunction | Cognitive Decline | Diabetic Neuropathy | BalancePakistan
-
Hacettepe UniversityGazi University; Saglik Bilimleri UniversitesiCompletedWalking | Cognition | Parkinson's Disease (PD) | Mobility | Balance | Dual-taskTurkey (Türkiye)
-
Riphah International UniversityCompletedIntellectual DisabilityPakistan
-
Riphah International UniversityCompleted
-
Universitas PadjadjaranNot yet recruitingStroke, CerebrovascularIndonesia
-
Eastern Mediterranean UniversityCompletedMild Cognitive ImpairmentCyprus
-
University of LahoreCompletedStroke | Hemiplegia | Hemiplegia Following Ischemic StrokePakistan
-
King Saud UniversityCompletedStroke | Chronic Stroke | Middle Cerebral Artery StrokeSaudi Arabia
-
Kutahya Health Sciences UniversityRecruiting