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Return to Physical Activity Following Injury: Towards Understanding a More Accessible Solution for Shorter Recovery Time.

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ClinicalTrials.gov Identifier: NCT03899714
Recruitment Status : Not yet recruiting
First Posted : April 2, 2019
Last Update Posted : April 2, 2019
Sponsor:
Information provided by (Responsible Party):
Abeer Farag Hanafy, Cairo University

Brief Summary:
The purpose of this study is to investigate the effect of cryotherapy application on hip adductors and ankle evertors on the Overall Stability Index (OSI), the Medio-Lateral Stability Index (MLSI), and the Antero-Posterior Stability Index (APSI) in healthy adult females.

Condition or disease Intervention/treatment Phase
Cryotherapy Other: Cryotherapy Not Applicable

Detailed Description:
Cryotherapy is one of the most common and inexpensive forms of treatment for both acute and chronic injuries. Yet, there is a deficiency in research concerning the impact of cooling on balance in healthy females

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Intervention Model Description: Participants will be randomly assigned into one of two locations of the cryotherapy application. Some began the session with cryotherapy being applied on their ankle evertors, while others began the session with the cryotherapy being applied on their hip adductors.
Masking: Single (Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Return to Physical Activity Following Injury: Towards Understanding a More Accessible Solution for Shorter Recovery Time.
Estimated Study Start Date : April 15, 2019
Estimated Primary Completion Date : May 15, 2019
Estimated Study Completion Date : June 1, 2019

Arm Intervention/treatment
Active Comparator: Ankle evertors
Ice packs will be applied to the selected muscles according to the random selection that will be performed previously. The ice bags will be filled with crushed ice, weighing approximately one half of a kilogram. They will be wrapped in a thin cotton towel, and applied on the skin along the anatomical location of the tested muscles. For the ankle evertors, the ice bag will be applied to the lateral side of the ankle encompassing the lateral malleolus.The cryotherapy session will be lasted for exactly 20 minutes . Sessions will be separated by a 30-minute rest interval
Other: Cryotherapy
Crushed ice in a plastic bag will be used, as it is a widely accessible and financially convenient method of cryotherapy. One half of a kilogram of ice will be placed in a plastic bag. The plastic bags will be 17 cm wide and 22 cm long. The air will be squeezed out of the bag and it will be sealed. The bag will be wrapped in a wet towel and applied to the tested area. Every five bags of crushed ice will be kept in an insulated foam container containing one kilogram of dry ice. Dry ice has a temperature of negative 80 degrees Celsius, and is used to keep the bags of crushed ice in a frozen state till the participants are briefed and the testing began.

Active Comparator: Hip adductors
Ice packs will be applied to the selected muscles according to the random selection that will be performed previously. The ice bags will be filled with crushed ice, weighing approximately one half of a kilogram. They will be wrapped in a thin cotton towel, and applied on the skin along the anatomical location of the tested muscles. For the hip adductors, the ice bag will be applied to the medial side of the thigh, covering the entire area from the groin, to just above the knee joint. The cryotherapy session will be lasted for exactly 20 minutes . Sessions will be separated by a 30-minute rest interval
Other: Cryotherapy
Crushed ice in a plastic bag will be used, as it is a widely accessible and financially convenient method of cryotherapy. One half of a kilogram of ice will be placed in a plastic bag. The plastic bags will be 17 cm wide and 22 cm long. The air will be squeezed out of the bag and it will be sealed. The bag will be wrapped in a wet towel and applied to the tested area. Every five bags of crushed ice will be kept in an insulated foam container containing one kilogram of dry ice. Dry ice has a temperature of negative 80 degrees Celsius, and is used to keep the bags of crushed ice in a frozen state till the participants are briefed and the testing began.




Primary Outcome Measures :
  1. Overall Stability Index [ Time Frame: changes from Baseline to immediately after the cryotherapy application ]
    The Stability Index represented the variance of platform displacement in degrees from a leveled position in both the AP and ML directions. A high number is indicative of poor neuromuscular control, which may increase the potential for orthopedic injury or falling.


Secondary Outcome Measures :
  1. Medio-lateral Postural Stability Index [ Time Frame: changes from Baseline to immediately after the cryotherapy application ]
  2. Antero-posterior Postural Stability index [ Time Frame: changes from Baseline to immediately after the cryotherapy application ]


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Ages Eligible for Study:   18 Years to 30 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • healthy females will participate in this study. All participants should have unrestricted ankle and hip joints range of motion as well as ankle and hip muscles strength grade four to five (using manual muscle testing).

Exclusion Criteria:

  • Participants will be excluded from the study if they had any previous history of hip or ankle joint neuromuscular or musculoskeletal injury or surgery, any pathology to the hip or ankle joints (i.e. abnormal ligament laxity and congenital deformities), any problems related to balance and stability.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03899714


Contacts
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Contact: Abeer F Hanafy, PhD 01063044443 abeerfarag22@gmail.com
Contact: Samar O Hassounah, Master 0237617691 dr.samarhassounah@gmail.com

Sponsors and Collaborators
Cairo University
Investigators
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Study Director: Ayman G Matar, PhD Lecturer of Biomechanics
Study Chair: Nagui S Nassif, Prof. Assistant Professor of Biomechanics
Study Chair: Naglaa M Elhafez, Prof. Professor of Biomechanics
Study Director: Ghada M Elhafez, Prof. Professor of Biomechanics
Study Chair: Sondus Hassounah, Public Health Teaching Fellow Public Health Teaching Fellow

Publications:
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Responsible Party: Abeer Farag Hanafy, Lecturer of Biomechanics, Cairo University
ClinicalTrials.gov Identifier: NCT03899714     History of Changes
Other Study ID Numbers: Cryotherapy and Balance
First Posted: April 2, 2019    Key Record Dates
Last Update Posted: April 2, 2019
Last Verified: March 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Abeer Farag Hanafy, Cairo University:
Postural Stability
Public Health
Balance