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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04469361
Other study ID # 09.2017.129
Secondary ID
Status Completed
Phase
First received
Last updated
Start date September 4, 2017
Est. completion date January 5, 2018

Study information

Verified date February 2017
Source Marmara University
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

Classic ballet dance is a demonstration of complex motor skills to be revealed in aesthetic combinations and repetitively, and it demands intensive use of the lower extremities within extreme of range of motion (ROM). Because ballet practice depends on advanced technical skills, it involves intensive physical training and causes an overload on the musculoskeletal system and foot deformities such as pes planus.

Plantar venous pump (PVP) is a network of multiple venous vessels located between the muscles of the foot arch. PVP is considered the first step of venous return and discharges into the posterior tibial vein (PTV). PVP is reported to be active during gait while it is inactive in resting position. There are different views on the mechanisms enabling its activation 1-3. The general view is that during the stance phase of the gait, the flattening of the plantar arch with weight transfer causes the veins in this region to narrow and creates a force that pumps the blood up.

The aim of this study is the investigation what kind of hemodynamic changes ballet training causes in the lower extremity


Recruitment information / eligibility

Status Completed
Enrollment 28
Est. completion date January 5, 2018
Est. primary completion date November 3, 2017
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 14 Years to 19 Years
Eligibility Inclusion Criteria (for balerinas):

- receiving ballet training at least 10 h per week for at least 4 years

- receiving formal dancing training system

Inclusion Criteria (for non-dancer group)

- never receiving formal dancing training

- having sedentary lifestyle

Exclusion Criteria:

- Participants with a history of foot or ankle surgery,

- Participants with connective tissue disease,

- Participants with rigid pes planus-cavus,

- Participants with chronic venous insufficiency

- Participants with acute ankle injury in recent 3 months

Study Design


Intervention

Other:
Navicular drop measurement
The difference in navicular height between sitting and standing positions was recorded (mm) as the amount of navicular drop.
Measurement of venous return parameters in supine
Venous return parameters of posterior tibial vein was measured when participant applied force equivalent to their own body weight on plantar surface of their right leg in supine position
Measurement of venous return parameters in standing
In standing, venous return parameters was measured of posterior tibial vein when participants shift all of their weight to the right leg for 3 second with their leg muscles as relaxed as possible and their knee joint in full extension.
measurement of midfoot pressure distrubition
In standing, midfoot pressure distrubution was measured when participants shift all of their weight to the right leg

Locations

Country Name City State
Turkey Marmara University Istanbul

Sponsors (1)

Lead Sponsor Collaborator
Marmara University

Country where clinical trial is conducted

Turkey, 

References & Publications (6)

Allen N, Nevill A, Brooks J, Koutedakis Y, Wyon M. Ballet injuries: injury incidence and severity over 1 year. J Orthop Sports Phys Ther. 2012 Sep;42(9):781-90. doi: 10.2519/jospt.2012.3893. Epub 2012 Jul 19. — View Citation

Gardner AM, Fox RH. The venous pump of the human foot--preliminary report. Bristol Med Chir J. 1983 Jul;98(367):109-12. — View Citation

Guss-West C, Wulf G. Attentional Focus in Classical Ballet: A Survey Of Professional Dancers. J Dance Med Sci. 2016 Mar;20(1):23-9. doi: 10.12678/1089-313X.20.1.23. — View Citation

Khan K, Brown J, Way S, Vass N, Crichton K, Alexander R, Baxter A, Butler M, Wark J. Overuse injuries in classical ballet. Sports Med. 1995 May;19(5):341-57. Review. — View Citation

Kim TI, Forbang NI, Criqui MH, Allison MA. Association of foot and ankle characteristics with progression of venous disease. Vasc Med. 2015 Apr;20(2):105-11. doi: 10.1177/1358863X14568443. — View Citation

Pearson SJ, Whitaker AF. Footwear in classical ballet: a study of pressure distribution and related foot injury in the adolescent dancer. J Dance Med Sci. 2012;16(2):51-6. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Evaluation of navicular drop Navicular drop was measured in mm Cchange from baseline navicular height in pre-intervention and immediately after the intervention/
Primary Evaluation of diameter of tibialis posterior vein in supine Diameter of tibialis posterior vein was measured in mm Change from baseline diameter of tibialis posterior vein during intervention
Primary Evaluation of flow velocity of tibialis posterior vein in supine Flow velocity of tibialis posterior vein was measured in cm/s Change from baseline flow velocity of tibialis posterior vein during intervention
Primary Evaluation of volume flow of tibialis posterior vein in supine Volume flow of tibialis posterior vein was measured in ml/min Change from baseline volume flow of tibialis posterior vein during intervention
Primary Evaluation of diameter of tibialis posterior vein during weight bearing Diameter of tibialis posterior vein was measured in mm Change from baseline diameter of tibialis posterior during intervention
Primary Evaluation of flow velocity of tibialis posterior vein during weight bearing Flow velocity of tibialis posterior vein was measured in cm/s Change from baseline flow velocity of tibialis posterior vein during intervention
Primary Evaluation of volume flow of tibialis posterior vein during weight bearing Volume flow of tibialis posterior vein was measured in ml/min Change from baseline volume flow of tibialis posterior vein during intervention
Primary Evaluation of midfoot plantar pressure during weight bearing Midfoot plantar pressure was measured in gr/cm2 Change from baseline midfoot pressure during intervention
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