Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12619001152112
Ethics application status
Approved
Date submitted
8/07/2019
Date registered
16/08/2019
Date last updated
13/11/2019
Date data sharing statement initially provided
16/08/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
Effects of Combining Mobilization of the Proximal Tibiofibular Joint and the Talocrural Joint in Subjects with Ankle Instability
Scientific title
Effects of Combining Mobilization of the Proximal Tibiofibular Joint and the Talocrural Joint in Subjects with Ankle Instability
Secondary ID [1] 298399 0
none
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Ankle instability 313117 0
Condition category
Condition code
Musculoskeletal 311594 311594 0 0
Other muscular and skeletal disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
There will be two experimental groups, in which all subjects will receive joint mobilization treatment for their proximal tibiofibular joints and the talocrural joints. One of the experimental groups will receive additional proximal tibiofibular joint mobilization in the direction of anterior glide, while the other experimental group will receive additional proximal tibiofibular joint mobilization in the direction of posterior glide. Dosage of the mobilization will be 2 sets of 10 repetitions at each joint, twice a week for 3 weeks. The intervention will be given by a physical therapist.
Intervention code [1] 314655 0
Treatment: Other
Intervention code [2] 314656 0
Rehabilitation
Comparator / control treatment
The comparison group will also receive joint mobilization treatment, but only to the talocrural joint. Dosage of mobilization will be 2 sets of 10 repetitions at each joint, twice a week for 3 weeks. The intervention will be also given by a physical therapist.
Control group
Active

Outcomes
Primary outcome [1] 320296 0
Range of ankle dorsiflexion measured by an inclinometer
Timepoint [1] 320296 0
Baseline, immediately after the 1st treatment session (primary timepoint), and after 3 weeks of the treatment
Primary outcome [2] 320297 0
Range of tibial internal rotation measured by a tibial rotational disc
Timepoint [2] 320297 0
Baseline, immediately after the 1st treatment session (primary timepoint), and after 3 weeks of the treatment
Primary outcome [3] 320298 0
Foot and ankle ability measure (FAAM)
Timepoint [3] 320298 0
Baseline and after 3 weeks of the treatment (primary timepoint)
Secondary outcome [1] 371096 0
Dynamic balance (Y balance test)
Timepoint [1] 371096 0
Baseline, immediately after the 1st treatment session, and after 3 weeks of the treatment
Secondary outcome [2] 371097 0
Time to stabilization after landing
Measurement tool: a force plate
Definition of time to stabilization: A period of time that required for the ground reaction forces exhibited after landing from a jump to stabilize within a range similar to that exhibited during a stable, single-limb stance
Timepoint [2] 371097 0
Baseline, immediately after the 1st treatment session, and after 3 weeks of the treatment
Secondary outcome [3] 371098 0
Peak ground reaction force
Measurement tool: a force plate
Definition: peak force magnitudes that occurred following contact
Timepoint [3] 371098 0
Baseline, immediately after the 1st treatment session, and after 3 weeks of the treatment
Secondary outcome [4] 376804 0
Range of ankle inversion/eversion measured by a goniometer
Timepoint [4] 376804 0
Baseline, immediately after the 1st treatment session, and after 3 weeks of the treatment

Eligibility
Key inclusion criteria
1. Age between 20-60
2. Greater than or equal to 1 significant ankle sprain and recurrent sprain greater than or equal to 2 times
3. Feeling of instability at the ankle
4. Compared to the opposite side ankle dorsiflexion range of motion greater than or equal to 5° deficit or the range is smaller than normal value
And
tibial internal range of motion greater than or equal to 5° deficit or the range if smaller than then normal value
Minimum age
20 Years
Maximum age
60 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Significant sprain or injury of the other ankle
2. Acute injury to musculoskeletal structures
3. History of proximal tibiofibular joint dislocation
4. History of fracture or surgeries of the tested lower limb
5. Visual impairments that affect balance, vestibular or neurologic functions

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Sealed-envelop technique for allocation concealment will be applied.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
14/10/2019
Actual
15/10/2019
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
60
Accrual to date
6
Final
Recruitment outside Australia
Country [1] 21571 0
Taiwan, Province Of China
State/province [1] 21571 0

Funding & Sponsors
Funding source category [1] 302940 0
University
Name [1] 302940 0
National Yang-Ming University
Country [1] 302940 0
Taiwan, Province Of China
Primary sponsor type
University
Name
National Yang-Ming University
Address
No.155, Sec.2, Li-Nong Street, Beitou District, Taipei, 11221, Taiwan.
Country
Taiwan, Province Of China
Secondary sponsor category [1] 302903 0
None
Name [1] 302903 0
Address [1] 302903 0
Country [1] 302903 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 303502 0
National Yang-Ming University
Ethics committee address [1] 303502 0
Ethics committee country [1] 303502 0
Taiwan, Province Of China
Date submitted for ethics approval [1] 303502 0
28/03/2019
Approval date [1] 303502 0
11/06/2019
Ethics approval number [1] 303502 0
YM108047F

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 93886 0
A/Prof Tzyy-Jiuan Wang
Address 93886 0
No.155, Sec.2, Li-Nong Street, Beitou District, Taipei, 11221, Taiwan.
National Yang-Ming University
Country 93886 0
Taiwan, Province Of China
Phone 93886 0
+886228267091
Fax 93886 0
Email 93886 0
[email protected]
Contact person for public queries
Name 93887 0
Tzyy-Jiuan Wang
Address 93887 0
No.155, Sec.2, Li-Nong Street, Beitou District, Taipei, 11221, Taiwan.
National Yang-Ming University
Country 93887 0
Taiwan, Province Of China
Phone 93887 0
+886228267091
Fax 93887 0
Email 93887 0
[email protected]
Contact person for scientific queries
Name 93888 0
Tzyy-Jiuan Wang
Address 93888 0
No.155, Sec.2, Li-Nong Street, Beitou District, Taipei, 11221, Taiwan.
National Yang-Ming University
Country 93888 0
Taiwan, Province Of China
Phone 93888 0
+886228267091
Fax 93888 0
Email 93888 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
TypeIs Peer Reviewed?DOICitations or Other DetailsAttachment
Plain language summaryNo 1.Study purpose: To compare the effects of differe... [More Details]

Documents added automatically
No additional documents have been identified.