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Trial record 36 of 345 for:    sprains and strains

Lateral Ankle Sprain Study

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ClinicalTrials.gov Identifier: NCT00761865
Recruitment Status : Terminated (low enrollment)
First Posted : September 30, 2008
Results First Posted : August 7, 2015
Last Update Posted : August 7, 2015
Sponsor:
Information provided by (Responsible Party):
Benedict Digiovanni, University of Rochester

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Lateral Ankle Sprain
Intervention Device: Air Cast Stirrup Brace & High Tide Fracture Boot
Enrollment 34
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Air Cast Stirrup Brace High Tide Fracture Boot
Hide Arm/Group Description

50 patients will be randomly assigned to receive the Air Cast Stirrup Brace.

Air Cast Stirrup Brace & High Tide Fracture Boot: Subjects will be randomly assigned to one of two treatment braces. All patients will be given instructions to use fracture boot or air cell brace at all times of ambulatory activity until follow-up until 2 week post-strain follow-up.

50 patients will be randomly assigned to the High Tide Fracture Boot.

Air Cast Stirrup Brace & High Tide Fracture Boot: Subjects will be randomly assigned to one of two treatment braces. All patients will be given instructions to use fracture boot or air cell brace at all times of ambulatory activity until follow-up until 2 week post-strain follow-up.

Period Title: Overall Study
Started 16 18
Completed 8 11
Not Completed 8 7
Reason Not Completed
Lost to Follow-up             8             7
Arm/Group Title Air Cast Stirrup Brace High Tide Fracture Boot Total
Hide Arm/Group Description

50 patients will be randomly assigned to receive the Air Cast Stirrup Brace.

Air Cast Stirrup Brace & High Tide Fracture Boot: Subjects will be randomly assigned to one of two treatment braces. All patients will be given instructions to use fracture boot or air cell brace at all times of ambulatory activity until follow-up until 2 week post-strain follow-up.

50 patients will be randomly assigned to the High Tide Fracture Boot.

Air Cast Stirrup Brace & High Tide Fracture Boot: Subjects will be randomly assigned to one of two treatment braces. All patients will be given instructions to use fracture boot or air cell brace at all times of ambulatory activity until follow-up until 2 week post-strain follow-up.

Total of all reporting groups
Overall Number of Baseline Participants 16 18 34
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 16 participants 18 participants 34 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
16
 100.0%
18
 100.0%
34
 100.0%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 16 participants 18 participants 34 participants
Female
8
  50.0%
5
  27.8%
13
  38.2%
Male
8
  50.0%
13
  72.2%
21
  61.8%
1.Primary Outcome
Title Modified Karlsson Score
Hide Description Ankle function score - range 0 to 100. Higher score is better ankle function.
Time Frame 2 weeks post-sprain
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Air Cast Stirrup Brace High Tide Fracture Boot
Hide Arm/Group Description:

50 patients will be randomly assigned to receive the Air Cast Stirrup Brace.

Air Cast Stirrup Brace & High Tide Fracture Boot: Subjects will be randomly assigned to one of two treatment braces. All patients will be given instructions to use fracture boot or air cell brace at all times of ambulatory activity until follow-up until 2 week post-strain follow-up.

50 patients will be randomly assigned to the High Tide Fracture Boot.

Air Cast Stirrup Brace & High Tide Fracture Boot: Subjects will be randomly assigned to one of two treatment braces. All patients will be given instructions to use fracture boot or air cell brace at all times of ambulatory activity until follow-up until 2 week post-strain follow-up.

Overall Number of Participants Analyzed 16 18
Mean (Full Range)
Unit of Measure: units on a scale
67
(33 to 92)
73
(41 to 95)
2.Secondary Outcome
Title Patient Satisfaction (Measured on a Visual Analog Scale)
Hide Description Satisfaction on 0-10 scale with 10 being the best.
Time Frame 2 weeks post-sprain
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Air Cast Stirrup Brace High Tide Fracture Boot
Hide Arm/Group Description:

50 patients will be randomly assigned to receive the Air Cast Stirrup Brace.

Air Cast Stirrup Brace & High Tide Fracture Boot: Subjects will be randomly assigned to one of two treatment braces. All patients will be given instructions to use fracture boot or air cell brace at all times of ambulatory activity until follow-up until 2 week post-strain follow-up.

50 patients will be randomly assigned to the High Tide Fracture Boot.

Air Cast Stirrup Brace & High Tide Fracture Boot: Subjects will be randomly assigned to one of two treatment braces. All patients will be given instructions to use fracture boot or air cell brace at all times of ambulatory activity until follow-up until 2 week post-strain follow-up.

Overall Number of Participants Analyzed 16 18
Mean (Full Range)
Unit of Measure: units on a scale
7
(2 to 9)
8
(2 to 10)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Air Cast Stirrup Brace High Tide Fracture Boot
Hide Arm/Group Description

50 patients will be randomly assigned to receive the Air Cast Stirrup Brace.

Air Cast Stirrup Brace & High Tide Fracture Boot: Subjects will be randomly assigned to one of two treatment braces. All patients will be given instructions to use fracture boot or air cell brace at all times of ambulatory activity until follow-up until 2 week post-strain follow-up.

50 patients will be randomly assigned to the High Tide Fracture Boot.

Air Cast Stirrup Brace & High Tide Fracture Boot: Subjects will be randomly assigned to one of two treatment braces. All patients will be given instructions to use fracture boot or air cell brace at all times of ambulatory activity until follow-up until 2 week post-strain follow-up.

All-Cause Mortality
Air Cast Stirrup Brace High Tide Fracture Boot
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Air Cast Stirrup Brace High Tide Fracture Boot
Affected / at Risk (%) Affected / at Risk (%)
Total   0/16 (0.00%)   0/18 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Air Cast Stirrup Brace High Tide Fracture Boot
Affected / at Risk (%) Affected / at Risk (%)
Total   0/16 (0.00%)   0/18 (0.00%) 
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Name/Title: Benedict DiGiovanni
Organization: University of Rochester
Phone: 5852731611
Responsible Party: Benedict Digiovanni, University of Rochester
ClinicalTrials.gov Identifier: NCT00761865     History of Changes
Other Study ID Numbers: 23552
First Submitted: September 29, 2008
First Posted: September 30, 2008
Results First Submitted: December 3, 2013
Results First Posted: August 7, 2015
Last Update Posted: August 7, 2015