Acute ankle sprain & rehabilitation – Effectiveness of a sensorimotor training intervention - individually adjusted by functional diagnostic parameters - on ankle joint function after first-time acute lateral ankle sprain.
Organizational Data
- DRKS-ID:
- DRKS00026049
- Recruitment Status:
- Recruiting ongoing
- Date of registration in DRKS:
- 2021-10-25
- Last update in DRKS:
- 2024-01-24
- Registration type:
- Prospective
Acronym/abbreviation of the study
OSGAR
URL of the study
No Entry
Brief summary in lay language
The project aims to develop an evidence-based and functional training program for the conservative treatment of an acute lateral ankle sprain. As a long-term result, the recurrence rate and chronic symptoms should be reduced. Furthermore, appropriate biomechanical markers for measuring a functional ankle instability will be determined in parallel with the study.
Brief summary in scientific language
This research project is carried out prospectively and monocentric as part of a randomized controlled longitudinal study. The aim is to prove the effectiveness of a multimodal sensorimotor training intervention (SMART-Treatment, SMART) in contrast to standard therapy (Normal Treatment, NORMT) after an acute ankle sprain on subjectively perceived ankle joint function. The measurements are before and after the six-week intervention phase as well as in a 6-, 12- and 24-month follow-up. As part of an accompanying cross-sectional study, an effective diagnostic inventory will be determined for the valid measurement of functional ankle instability.
Health condition or problem studied
- ICD10:
- S93.4 - Sprain and strain of ankle
- Healthy volunteers:
- No Entry
Interventions, Observational Groups
- Arm 1:
- SMART: Six-week intervention consisting of the following domains: S=Sensory Stimulation M=Mobility A=Activation & Balance R=Resistance T=Transfer to Function and Performance
- Arm 2:
- NORMT: Standard therapy (physiotherapy)
Endpoints
- Primary outcome:
- Cumberland Ankle Instability Tool (CAIT): Psychometric questionnaire which measures regional functional impairments of the participants. The measurements are before and after the six-week intervention phase as well as in a 6-, 12- and 24-month follow-up.
- Secondary outcome:
- - Foot and Ankle Ability Measure (FAAM) - Isometric/Isokinetic strength diagnostics - gait/run analysis - jump analysis The FAAM is collected before and after the six-week intervention phase as well as in a 6-, 12- and 24-month follow-up. Isometric/Isokinetic strength diagnostics, gait/run analysis and jump analysis are conducted before and after the six-week intervention phase as well as in a 6-month follow-up.
Study Design
- Purpose:
- Treatment
- Allocation:
- Randomized controlled study
- Control:
-
- Active control (effective treatment of control group)
- Phase:
- N/A
- Study type:
- Interventional
- Mechanism of allocation concealment:
- No Entry
- Blinding:
- No
- Assignment:
- Parallel
- Sequence generation:
- No Entry
- Who is blinded:
- No Entry
Recruitment
- Recruitment Status:
- Recruiting ongoing
- Reason if recruiting stopped or withdrawn:
- No Entry
Recruitment Locations
- Recruitment countries:
-
- Germany
- Number of study centers:
- Monocenter study
- Recruitment location(s):
-
- Medical center BG Klinikum Duisburg
Recruitment period and number of participants
- Planned study start date:
- 2022-01-03
- Actual study start date:
- 2022-01-03
- Planned study completion date:
- 2025-12-31
- Actual Study Completion Date:
- No Entry
- Target Sample Size:
- 82
- Final Sample Size:
- No Entry
Inclusion Criteria
- Sex:
- All
- Minimum Age:
- 14 Years
- Maximum Age:
- 41 Years
- Additional Inclusion Criteria:
- - ICD-Code S93.4x „sprain of the ankle“ - 14-41 years - BMI: 19-30 - rupture of at least one lateral ligament of the ankle joint
Exclusion Criteria
- acute concomitant injuries of the ankle joint (fractures, syndesmosis ligament injury, osteochondral lesions) - pre-injuries of the injured and non-injured ankle - serious lower-extremity injuries in the last 6 months (e.g. fractures, ligament ruptures) - lower-extremity surgery (e.g. ACL-reconstruction) - neurological diseases or impairements of the vestibular system which could influence the physiological or sensorimotor performance
Addresses
Primary Sponsor
- Address:
- BG Klinikum Duisburg Klinik für Arthroskopische Chirurgie, Sporttraumatologie und SportmedizinDr. Christian SchoeppGroßenbaumer Allee 25047249 DuisburgGermany
- Telephone:
- +49 203 7688 3401
- Fax:
- +49 203 7688 443129
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- No Entry
- Investigator Sponsored/Initiated Trial (IST/IIT):
- Yes
Contact for Scientific Queries
- Address:
- BG Klinikum Duisburg gGmbHDr. Tobias OhmannGroßenbaumer Allee 25047249 DuisburgGermany
- Telephone:
- 0203 7688 3129
- Fax:
- 0203 7688 443129
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- No Entry
Contact for Public Queries
- Address:
- BG Klinikum DuisburgJanina TennlerGroßenbaumer Allee 25047249 DuisburgGermany
- Telephone:
- 0203 7688 2744
- Fax:
- 0203 7688 443315
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- No Entry
Principal Investigator
- Address:
- BG Klinikum Duisburg gGmbHDr. Tobias OhmannGroßenbaumer Allee 25047249 DuisburgGermany
- Telephone:
- 0203 7688 3129
- Fax:
- 0203 7688 443129
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- No Entry
Sources of Monetary or Material Support
Public funding institutions financed by tax money/Government funding body (German Research Foundation (DFG), Federal Ministry of Education and Research (BMBF), etc.)
- Address:
- DGUV – ForschungsförderungAlte Heerstrasse 11153757 Sankt AugustinGermany
- Telephone:
- No Entry
- Fax:
- No Entry
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- No Entry
Institutional budget, no external funding (budget of sponsor/PI)
- Address:
- BG Klinikum Duisburg Klinik für Arthroskopische Chirurgie, Sporttraumatologie und SportmedizinGroßenbaumer Allee 25047249 DuisburgGermany
- Telephone:
- +49 203 7688 3401
- Fax:
- +49 203 7688 443129
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- No Entry
Ethics Committee
Address Ethics Committee
- Address:
- Ethikkommission der Ärztekammer NordrheinTersteegenstr. 940474 DüsseldorfGermany
- Telephone:
- +49-211-43021581
- Fax:
- +49-211-43021585
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- No Entry
Vote of leading Ethics Committee
- Vote of leading Ethics Committee
- Date of ethics committee application:
- 2021-06-09
- Ethics committee number:
- 2021236
- Vote of the Ethics Committee:
- Approved
- Date of the vote:
- 2021-10-01
Further identification numbers
- Other primary registry ID:
- No Entry
- EudraCT Number:
- No Entry
IPD - Individual Participant Data
- Do you plan to make participant-related data (IPD) available to other researchers in an anonymized form?:
- No
- IPD Sharing Plan:
- No Entry
Study protocol and other study documents
- Study protocols:
- No Entry
- Study abstract:
- No Entry
- Other study documents:
- No Entry
- Background literature:
- No Entry
- Related DRKS studies:
- No Entry
Publication of study results
- Planned publication:
- No Entry
- Publikationen/Studienergebnisse:
- No Entry
- Date of first publication of study results:
- No Entry
- DRKS entry published for the first time with results:
- No Entry
Basic reporting
- Basic Reporting / Results tables:
- No Entry
- Brief summary of results:
- No Entry