NCT03899714

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

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Apr 2019

Shorter than P25 for not_applicable

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 31, 2019

Completed
2 days until next milestone

First Posted

Study publicly available on registry

April 2, 2019

Completed
13 days until next milestone

Study Start

First participant enrolled

April 15, 2019

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 15, 2019

Completed
17 days until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2019

Completed
Last Updated

April 2, 2019

Status Verified

March 1, 2019

Enrollment Period

1 month

First QC Date

March 31, 2019

Last Update Submit

April 1, 2019

Conditions

Keywords

Postural StabilityPublic HealthBalance

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 COMPARATOR

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

Hip adductors

ACTIVE COMPARATOR

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

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.

Ankle evertorsHip adductors

Eligibility Criteria

Age18 Years - 30 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

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

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: 17224445BACKGROUND
  • Bleakley 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

Cryotherapy

Intervention Hierarchy (Ancestors)

Therapeutics

Study Officials

  • Ayman G Matar, PhD

    Lecturer of Biomechanics

    STUDY DIRECTOR
  • Nagui S Nassif, Prof.

    Assistant Professor of Biomechanics

    STUDY CHAIR
  • Naglaa M Elhafez, Prof.

    Professor of Biomechanics

    STUDY CHAIR
  • Ghada M Elhafez, Prof.

    Professor of Biomechanics

    STUDY DIRECTOR
  • Sondus Hassounah, Public Health Teaching Fellow

    Public Health Teaching Fellow

    STUDY CHAIR

Central Study Contacts

Abeer F Hanafy, PhD

CONTACT

Samar O Hassounah, Master

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
CROSSOVER
Model Details: 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.
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