Objectives: Evaluating he immediate effect of talocrural joint manipulation on functional performance of athletes with chronic ankle instability
Design: Double-Blind Randomized Controlled Trial
Participants: Forty athletes (18males, 22females) with chronic ankle instability
Inclusion criteria: Athletes between 15-40 years old; at least one acute ankle sprain (grade I or II) before previous 6 weeks or multiple giving way in ankle joint in previous 12 months
Exclusion criteria: Neurological diseases; rheumatoid diseases and fractures in lower limbs; ankle sprain grade III; ankle sprain occurred during the previous 6 weeks, regardless of the grade
Intervention: For manipulation, therapist delivers a quick thrust on the talus in the posterior direction. This position is simulated for 1 minute without thrust as sham manipulation in the control group. Interventions carry out one time per day, for three consecutive days.
Main outcome measures: Functional performance of athletes assesses with single leg hop test, speed test, and Y balance test, before and after the interventions
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2016021624149N25
Registration date:2016-07-13, 1395/04/23
Registration timing:retrospective
Last update:
Update count:0
Registration date
2016-07-13, 1395/04/23
Registrant information
Name
Fahimeh Kamali
Name of organization / entity
Shiraz University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 71 1627 1551
Email address
kamalif@sums.ac.ir
Recruitment status
Recruitment complete
Funding source
Shiraz University of Medical Sciences
Expected recruitment start date
2013-11-22, 1392/09/01
Expected recruitment end date
2014-01-21, 1392/11/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The immediate effect of talocrural joint manipulation on functional performance of 15-40 years old athletes with chronic ankle instability
Public title
The effect of manual therapy on performance of athletes with chronic ankle instability
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Athletes between 15-40 years old; at least one acute ankle sprain (grade I or II) before previous 6 weeks or multiple giving way in ankle joint in previous 12 months; ability to complete the 24-meter running test without pain; muscle power of the affected leg should be at least 80% of the healthy side
Exclusion criteria:
Neurological diseases; rheumatoid diseases; postural disorders; fractures in lower limbs; flat foot; sacroiliac joint impairments; ankle sprain grade III; ankle sprain occurred during the previous 6 weeks, regardless of the grade
Age
From 15 years old to 40 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
40
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Vice-Chancellery for Research Office, Shiraz University of Medical Sciences
Street address
Central Building of Shiraz University of Medical Sciences, Zand Blvd, Shiraz
City
Shiraz
Postal code
Approval date
2013-11-02, 1392/08/11
Ethics committee reference number
CT-92-6752
Health conditions studied
1
Description of health condition studied
Chronic Ankle Instability
ICD-10 code
S93.4
ICD-10 code description
Sprain and strain of ankle
Primary outcomes
1
Description
Functional Performance
Timepoint
before and after interventions
Method of measurement
One-leg hop test
2
Description
Functional performance
Timepoint
before and after interventions
Method of measurement
Speed test
3
Description
Functional performance
Timepoint
before and after interventions
Method of measurement
Star excursion test
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Manipulation
Category
Rehabilitation
2
Description
Control group: Placebo
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Physiotherapy Center of School of Rehabilitation Sciences
Full name of responsible person
Fahimeh Kamali
Street address
Abiverdi St. Chamran Blvd. Shiraz
City
Shiraz
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellery for research affairs, Shiraz University of Medical Sciences
Full name of responsible person
Basir Hashemi
Street address
Central Building of Shiraz University of Medical Sciences, Zand Blvd. Shiraz
City
Shiraz
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice chancellery for research affairs, Shiraz University of Medical Sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
School of Rehabilitation Sciences, Shiraz University of Medical Sciences
Full name of responsible person
Fahimeh Kamali
Position
Associate Professor
Other areas of specialty/work
Street address
Abiverdi St. Chamran Blvd. Shiraz
City
Shiraz
Postal code
Phone
+98 71 3627 1551
Fax
Email
kamalif@sums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
School of Rehabilitation Sciences, Shiraz University of Medical Sciences
Full name of responsible person
Fahimeh Kamali
Position
Associate Professor
Other areas of specialty/work
Street address
Abiverdi St. Chamran Blvd. Shiraz
City
Shiraz
Postal code
Phone
+98 71 3627 1551
Fax
Email
kamalif@sums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
School of Rehabilitation Sciences, Shiraz University of Medical Sciences
Full name of responsible person
Fahimeh Kamali
Position
Associate Professor
Other areas of specialty/work
Street address
Abiverdi St. Chamran Blvd. Shiraz
City
Shiraz
Postal code
Phone
+98 71 3627 1551
Fax
Email
kamalif@sums.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)