Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12616000217404
Ethics application status
Approved
Date submitted
25/11/2015
Date registered
17/02/2016
Date last updated
17/02/2016
Type of registration
Retrospectively registered

Titles & IDs
Public title
The effect of joint mobilization on neuromuscular performance in individuals with functional ankle instability
Scientific title
For subjects with functional ankle instability, what is the immediate and short-term effect of joint mobilization with training v.s. training and sham massage on cortico-spinal excitability?
Secondary ID [1] 287994 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Functional ankle instability 296875 0
Condition category
Condition code
Physical Medicine / Rehabilitation 297105 297105 0 0
Physiotherapy
Musculoskeletal 297106 297106 0 0
Other muscular and skeletal disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
For the joint mobilization with training group, a licensed physiotherapist provided the ankle joint distraction, talocrural joint posterior glide, distal tibiofibular joint posterior glide, ankle stabilization exercise training (e.g.one-leg standing exercise, one-leg squat) and calf muscle self-stretching exercise. The whole intervention was administrated by an experienced physical therapist, and no strategy was used to monitor the adherence to the intervention. The total duration for manual therapy took about 15 minutes, and the duration for exercise training took about 15 to 30 minutes, twice a week, last for four weeks.Participants do not need to undertake the training exercise in their own time. All the intervention was administered on an individual.
Intervention code [1] 293333 0
Rehabilitation
Intervention code [2] 293403 0
Treatment: Other
Comparator / control treatment
There are two control group, education group and training and sham massage group. For education group, subjects only received one session of education include how to self stretch the calf muscle. Subjects in this group were not asked to do the stretching exercise in their own time at home. For training and sham massage group, physiotherapist only provided the ankle stabilization exercise training (e.g.one-leg standing exercise, one-leg squat) and lightly place the hand over the calf muscle for the sham massage. The total duration took about 15 to 30 minutes, twice a week, last for 4 weeks. The whole intervention was administrated on an individual by an experienced physical therapist, and no strategy was used to monitor the adherence to the intervention. Participants were not asked to undertake any of the training exercises in their own time in the training and sham massage group. Healthy control subjects didn't received any intervention in this study. they were only used for the the baseline comparison with patients group.
Control group
Placebo

Outcomes
Primary outcome [1] 296714 0
The cortico-spinal excitability, including active motor threshold (AMT) , motor evoked potential (MEP) and the cortical silent period, were examined by transcranial magnetic stimulation (TMS)(MagStim 200 stimulator, MagStim Company,UK )
Timepoint [1] 296714 0
Baseline: immediately after the history taking and interview.
immediate effect: immediately after the first intervention.
short-term effect: after the final treatment, the evaluation should finished within two days.
Secondary outcome [1] 319169 0
Functional performance of ankle by Cumberland Ankle Instability Tool (CAIT)
Timepoint [1] 319169 0
Baseline: immediately after the history taking and interview.
immediate effect: immediately after the first intervention.
short-term effect: after the final treatment, the evaluation should finished within two days.
Secondary outcome [2] 319170 0
Calf muscle flexibility by weight bearing lunge test
Timepoint [2] 319170 0
Baseline: immediately after the history taking and interview.
immediate effect: immediately after the first intervention.
short-term effect: after the final treatment, the evaluation should finished within two days.
Secondary outcome [3] 319171 0
Muscle strength by hand-held dynamometer:Power Track II
Timepoint [3] 319171 0
Baseline: immediately after the history taking and interview.
immediate effect: immediately after the first intervention.
short-term effect: after the final treatment, the evaluation should finished within two days.
Secondary outcome [4] 319172 0
Mean EMG data of the fibularis longus (FL) , tibialis anterior (TA) , and soleus (SOL) were measured during the eccentric phase of the Y balance test by surface electromyography
Timepoint [4] 319172 0
Baseline: immediately after the history taking and interview.
immediate effect: immediately after the first intervention.
short-term effect: after the final treatment, the evaluation should finished within two days.

Eligibility
Key inclusion criteria
Patients with functional ankle instability with age between 20 and 50 years old; score of Cumberland Ankle Instability Tool (CAIT) lower than 27; one or more positive signs in the following criteria: (1) Had a serious inversion ankle sprain following with swelling, pain and functional impairment within a year; (2) recurrence of ankle sprain on the affected foot or any symptom of weakness and giving way.
For healthy subjects, the inclusion criteria included age between 20 and 50 years old, no past history of lower extremity surgery, and no past history of lower extremity injury within six week. Score of Cumberland Ankle Instability Tool (CAIT) greater than 28.
Minimum age
20 Years
Maximum age
50 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
(1) ankle sprain within 6 weeks; (2) a history of lower extremity fracture or surgery; (3) seizure; (4) any mental implantation; (5) positive sign in anterior drawer test or talar tilt test; (6) neurological disease, pregnant, or serious systemic disease which might effect subjects' balance control

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)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
12/12/2014
Date of last participant enrolment
Anticipated
Actual
7/06/2015
Date of last data collection
Anticipated
Actual
Sample size
Target
55
Accrual to date
Final
55
Recruitment outside Australia
Country [1] 7375 0
Taiwan, Province Of China
State/province [1] 7375 0
Taipei

Funding & Sponsors
Funding source category [1] 292456 0
University
Name [1] 292456 0
National Yang Ming University
Country [1] 292456 0
Taiwan, Province Of China
Primary sponsor type
Individual
Name
Yi-fen Shih
Address
No. 155, Li-Nong Street Section 2, Pei-Tou District,
National Yang-Ming University Department of Physical Therapy and Assistive Technology Taipei, Taiwan 112
Country
Taiwan, Province Of China
Secondary sponsor category [1] 291154 0
None
Name [1] 291154 0
Nil
Address [1] 291154 0
Nil
Country [1] 291154 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 293918 0
Institutional Review Board of National Yang-Ming University
Ethics committee address [1] 293918 0
Ethics committee country [1] 293918 0
Taiwan, Province Of China
Date submitted for ethics approval [1] 293918 0
Approval date [1] 293918 0
02/12/2014
Ethics approval number [1] 293918 0

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

Contacts
Principal investigator
Name 61814 0
A/Prof Yi-Fen Shih
Address 61814 0
No. 155, Li-Nong Street Section 2, Pei-Tou District,
National Yang-Ming University Department of Physical Therapy and Assistive Technology Taipei, Taiwan 112.
Country 61814 0
Taiwan, Province Of China
Phone 61814 0
+886 2 2826 7340
Fax 61814 0
+886 2 2820 1841
Email 61814 0
[email protected]
Contact person for public queries
Name 61815 0
Yi-Fen Shih
Address 61815 0
No. 155, Li-Nong Street Section 2, Pei-Tou District,
National Yang-Ming University Department of Physical Therapy and Assistive Technology Taipei, Taiwan 112.
Country 61815 0
Taiwan, Province Of China
Phone 61815 0
+886 2 2826 7340
Fax 61815 0
+886 2 2820 1841
Email 61815 0
[email protected]
Contact person for scientific queries
Name 61816 0
Yi-Fen Shih
Address 61816 0
No. 155, Li-Nong Street Section 2, Pei-Tou District,
National Yang-Ming University Department of Physical Therapy and Assistive Technology Taipei, Taiwan 112.
Country 61816 0
Taiwan, Province Of China
Phone 61816 0
+886 2 2826 7340
Fax 61816 0
+886 2 2820 1841
Email 61816 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
SourceTitleYear of PublicationDOI
EmbaseThe effect of additional joint mobilization on neuromuscular performance in individuals with functional ankle instability.2018https://dx.doi.org/10.1016/j.ptsp.2017.12.001
N.B. These documents automatically identified may not have been verified by the study sponsor.