- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04210518
Balance Training With Stroboscopic Vision
December 20, 2019 updated by: DAVID CRUZ DÍAZ, University of Jaen
Influence of Stroboscopic Vision on Balance in Patients With Chronic Ankle Instability
Balance training with stroboscopic vision in patients with chronic ankle instability.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
This study was a single-blinded randomized controlled trial with two intervention groups consisted in multimodal balance training, multimodal balance training in addition to stroboscopic glasses and control group who received no intervention.
Study Type
Interventional
Enrollment (Actual)
75
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Jaen, Spain, 23071
- University of Jaén
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 60 years (ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- a previous episode of ankle sprain in at least 6 months before the beginning of the study
- a score of 25 or less in the Cumberland Ankle Instability Tool
- no history of others musculoskeletal injuries in the lower limbs
Exclusion Criteria:
- an acute ankle sprain within the last six weeks
- Recent lower limb surgery
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: TRIPLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: Neuromuscular training
Neuromuscular training consisting of:
|
This intervention consisted of a supervised multimodal exercise protocol addressing different aspects of balance including static and dynamic tasks on the injured ankle.
The training program comprised 6 exercises that were progressively adapted depending on the patient's execution controlled by an expert physiotherapist
|
EXPERIMENTAL: Stroboscopic glasses group
This group performed the same neuromuscular training with the addition of stroboscopic glasses during the training performance.
|
Patients included in this group performed the same protocol described in the balance training group with the addition of the stroboscopic glasses during the intervention.
|
NO_INTERVENTION: Control group
This group received no intervention
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Ankle range of motion
Time Frame: From baseline to six weeks.
|
Ankle dorsiflexion range of motion was assessed by the weight-bearing lunge test.
The patient is positioned in a standing position facing a wall with the involved foot parallel with a tape measure which has been attached to the floor and the opposite leg placed behind in a tandem stance.
A forward lunge is performed until the anterior knee tries to make contact with the wall with the heel firmly planted on the ground.
|
From baseline to six weeks.
|
Dynamic balance
Time Frame: From baseline to six weeks.
|
Dynamic balance has been measured by a simplified version of the Star Excursion Balance Test where the anterior, posteromedial and posterolateral reach directions were collected for statistical analysis.
|
From baseline to six weeks.
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Self-reported instability and function
Time Frame: From baseline to six weeks.
|
To determine the severity of ankle instability the Cumberland ankle instability tool.
This questionnaire is a nine items questionnaire ranged from 0 to 30 (0 related with severe impairment and 30 no subjective instability feeling) and has been reported to be a valid tool with high internal consistency and reliability.
|
From baseline to six weeks.
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (ACTUAL)
May 2, 2019
Primary Completion (ACTUAL)
July 10, 2019
Study Completion (ACTUAL)
July 20, 2019
Study Registration Dates
First Submitted
December 8, 2019
First Submitted That Met QC Criteria
December 20, 2019
First Posted (ACTUAL)
December 24, 2019
Study Record Updates
Last Update Posted (ACTUAL)
December 24, 2019
Last Update Submitted That Met QC Criteria
December 20, 2019
Last Verified
December 1, 2019
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- UJASB
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
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 Proprioceptive Disorders
-
KU LeuvenUniversitaire Ziekenhuizen KU LeuvenCompletedProprioceptive Postural ControlBelgium
-
Istanbul Aydın UniversityPamukkale UniversityActive, not recruitingHemiparesis Proprioceptive Disorders Gait, Hemiplegic, Healthy Individual, Comparative StudyTurkey
-
University Hospital, CaenCompletedProprioceptive DisordersFrance
-
Dokuz Eylul UniversityCompletedProprioceptive DisordersTurkey
-
Investigación en Hemofilia y FisioterapiaCompletedProprioceptive DisordersSpain
-
Investigación en Hemofilia y FisioterapiaCompletedProprioceptive DisordersSpain
-
Investigación en Hemofilia y FisioterapiaWithdrawnProprioceptive DisordersSpain
-
Ayman MohamedUnknown
-
Investigación en Hemofilia y FisioterapiaCompletedProprioceptive DisordersSpain
-
Istituto Ortopedico RizzoliUniversity of BolognaCompleted
Clinical Trials on Neuromuscular training
-
Riphah International UniversityCompletedAnterior Cruciate Ligament InjuriesPakistan
-
Investigación en Hemofilia y FisioterapiaCompleted
-
The University of Hong KongUnknownDevelopmental Coordination DisorderHong Kong
-
University of Colorado, DenverCompletedBrain Concussion | Postural Balance | Musculoskeletal Injury | LocomotionUnited States
-
Children's Hospital Medical Center, CincinnatiNational Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS) and other collaboratorsCompletedACL InjuryUnited States
-
Children's Hospital Medical Center, CincinnatiCompletedBrain ConcussionUnited States
-
The Methodist Hospital Research InstituteCompleted
-
Acibadem UniversityIstanbul UniversityCompletedBasketball Players | Healthy Young WomenTurkey
-
Schulthess KlinikCompletedSymptomatic Femoroacetabular ImpingementSwitzerland