Return to Physical Activity Following Injury: Towards Understanding a More Accessible Solution for Shorter Recovery Time.
1 other identifier
interventional
30
0 countries
N/A
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Apr 2019
Shorter than P25 for not_applicable
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 31, 2019
CompletedFirst Posted
Study publicly available on registry
April 2, 2019
CompletedStudy Start
First participant enrolled
April 15, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 15, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2019
CompletedApril 2, 2019
March 1, 2019
1 month
March 31, 2019
April 1, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Overall Stability Index
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.
changes from Baseline to immediately after the cryotherapy application
Secondary Outcomes (2)
Medio-lateral Postural Stability Index
changes from Baseline to immediately after the cryotherapy application
Antero-posterior Postural Stability index
changes from Baseline to immediately after the cryotherapy application
Study Arms (2)
Ankle evertors
ACTIVE COMPARATORIce 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
Hip adductors
ACTIVE COMPARATORIce 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
Interventions
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.
Eligibility Criteria
You may qualify if:
- 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).
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Cairo Universitylead
Related Publications (2)
Algafly AA, George KP. The effect of cryotherapy on nerve conduction velocity, pain threshold and pain tolerance. Br J Sports Med. 2007 Jun;41(6):365-9; discussion 369. doi: 10.1136/bjsm.2006.031237. Epub 2007 Jan 15.
PMID: 17224445BACKGROUNDBleakley C, McDonough S, MacAuley D. The use of ice in the treatment of acute soft-tissue injury: a systematic review of randomized controlled trials. Am J Sports Med. 2004 Jan-Feb;32(1):251-61. doi: 10.1177/0363546503260757.
PMID: 14754753BACKGROUND
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- 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
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- PREVENTION
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Lecturer of Biomechanics
Study Record Dates
First Submitted
March 31, 2019
First Posted
April 2, 2019
Study Start
April 15, 2019
Primary Completion
May 15, 2019
Study Completion
June 1, 2019
Last Updated
April 2, 2019
Record last verified: 2019-03