Trial document
This trial has been registered retrospectively.
DRKS00009979
Trial Description
Title
Evaluation of the influence of active controlled motion (ACM) after operatively treated ankle fractures type Weber-B and -C with the necessity for partial weightbearing for 6 weeks
Trial Acronym
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URL of the Trial
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Brief Summary in Lay Language
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Brief Summary in Scientific Language
Up to now there is almost no information about proprioceptive deficits after ankle fractures and their role in the rehabilitation process. However, it is known that in the knee joint there is no correlation between mechanical and subjective instability after rupture of the anterior cruciate ligament (ACL) but between proprioception and subjective instability and active controlled motion can decrease the proprioceptive deficit.Proprioceptive training of ankle fractures is commonly done with balance boards or balance circles. In patients with need of partial weightbearing this is not possible until full weightbearing is allowed. The aim of this study was to look for possible beneficial rehabilitation effects in the use of active controlled motion after operatively treated unstable ankle fractures with the need of partial weightbearing in the first six postoperative weeks.
Do you plan to share individual participant data with other researchers?
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Description IPD sharing plan:
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Organizational Data
- DRKS00009979
- 2016/02/02
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- yes
- Approved
- 159/10, Ethik-Kommission der Medizinischen Fakultät der Universität Würzburg
Secondary IDs
- U1111-1179-0173
Health Condition or Problem studied
- S82.6 - Fracture of lateral malleolus
- S82.8 - Fractures of other parts of lower leg
Interventions/Observational Groups
- physiotherapy 2-3 times/weeks for 6 weeks postoperatively
- physiotherapy 2-3 times/weeks plus additional exercise 20 minutes a day with an active controlled motion device for 6 weeks postoperatively
Characteristics
- Interventional
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- Randomized controlled trial
- Open (masking not used)
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- Active control (effective treament of control group)
- Treatment
- Parallel
- I
- N/A
Primary Outcome
Range of motion of the ankle joint after 6 weeks
Secondary Outcome
Range of motion of the ankle joint after 12 weeks; Range of motion of the subtalar joint after 6 and 12 weeks; changes in gait patterns after 6 and 12 weeks, results in questionnaires VAS FA, AOFAS, Mazur Score, Phillip-Score; Return to work
Countries of Recruitment
- Germany
Locations of Recruitment
- University Medical Center
Recruitment
- Actual
- 2010/11/01
- 50
- Monocenter trial
- National
Inclusion Criteria
- Both, male and female
- 18 Years
- 99 Years
Additional Inclusion Criteria
Operatively treated unstable ankle fractures type B- or C in the Weber classification between 01.11.2010-30.09.2011 with the need of partial weightbearing for six weeks as the only injury, age over 18 years, possibility to perform active controlled motion and no problems in walking before the injury; verbal and written consent to participate in the study
Exclusion Criteria
psychiatric comorbidities; unable to perform partial weightbearing
Addresses
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start of 1:1-Block address primary-sponsor
- Universitätsklinikum Würzburg
- Josef-Schneider-Str.
- 97080 Würzburg
- Germany
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- http://www.klinik.uni-wuerzburg.de
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start of 1:1-Block address scientific-contact
- Universitätsklinikum Würzburg
- Mr. PD Dr. Hendrik Jansen
- Josef-Schneider-Str.
- 97080 Würzburg
- Germany
end of 1:1-Block address scientific-contactstart of 1:1-Block address contact scientific-contact- +4993120137001
- +4993120137009
- jansen_h at ukw.de
- http://www.klinik.uni-wuerzburg.de
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start of 1:1-Block address public-contact
- Universitätsklinikum Würzburg
- Mr. PD Dr. med. Hendrik Jansen
- Josef-Schneider-Str.
- 97080 Würzburg
- Germany
end of 1:1-Block address public-contactstart of 1:1-Block address contact public-contact- +4993120137001
- +4993120137009
- jansen_h at ukw.de
- http://www.klinik.uni-wuerzburg.de
end of 1:1-Block address contact public-contact
Sources of Monetary or Material Support
-
start of 1:1-Block address materialSupport
- Universitätsklinikum Würzburg
- Josef-Schneider-Str.
- 97080 Würzburg
- Germany
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- http://www.klinik.uni-wuerzburg.de
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Status
- Recruiting complete, follow-up complete
- 2014/01/10
Trial Publications, Results and other Documents
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