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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]

None

Universal Trial Number (UTN)

Trial acronym

Linked study record

Health condition

Health condition(s) or problem(s) studied:

Functional ankle instability

Condition category

Condition code

Physical Medicine / Rehabilitation

Physiotherapy

Musculoskeletal

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]

Rehabilitation

Intervention code [2]

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]

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]

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]

Functional performance of ankle by Cumberland Ankle Instability Tool (CAIT)

Timepoint [1]

Secondary outcome [2]

Calf muscle flexibility by weight bearing lunge test

Timepoint [2]

Secondary outcome [3]

Muscle strength by hand-held dynamometer:Power Track II

Timepoint [3]

Secondary outcome [4]

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]

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

Accrual to date

Final

Recruitment outside Australia

Country [1]

Taiwan, Province Of China

State/province [1]

Taipei

Funding & Sponsors

Funding source category [1]

University

Name [1]

National Yang Ming University

Address [1]

No. 155, Li-Nong Street Section 2, Pei-Tou District,Taipei, Taiwan 112.

Country [1]

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]

None

Name [1]

Nil

Address [1]

Nil

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Institutional Review Board of National Yang-Ming University

Ethics committee address [1]

No. 155, Li-Nong Street Section 2, Pei-Tou District,
Institutional Review Board of National Yang-Ming University
Taipei, Taiwan 112.

Ethics committee country [1]

Taiwan, Province Of China

Date submitted for ethics approval [1]

Approval date [1]

02/12/2014

Ethics approval number [1]

Summary

Brief summary

Objective: Study 1: To determine if differences in cortico-spinal excitability were present between subjects with FAI. Study 2: To examine the immediate and short-term effect of joint mobilization on cortico-spinal excitability in subjects with FAI. 
Methods: Study 1 is a observational study. We recruited 11 healthy subjects and 11 FAI, then compared the difference in all out come measurements. Study 2 is a single blind, randomized controlled trial. We recruited 45 FAI participants with self-reported ankle instability , randomly assigned to control group, training group and mobilization with training group. Mean EMG data from the fibularis longus (FL) , tibialis anterior (TA) , and soleus (SOL) were measured during the eccentric phase of the Y balance test. Single pulse transcranial magnetic stimulation (TMS) was performed, and the active motor threshold (AMT) , motor evoked potential (MEP) and the cortical silent period were recorded. To examine the immediate effect, one session of ankle joint mobilization was performed for the FAI group. Participants in both the TG and MTG were trained by a physical therapist twice weekly for 4 weeks, and participants in the MTG received additional joint mobilization in every treatment (Maitland grade II and III anterior to posterior joint mobilization to talocural joint and distal tibiofibular joint) . 
Results:
Study 1: The FAI group demonstrated a significantly decreased active and passive dorsi-flexion ROM than healthy subjects. In Y balance three direction reach, the FAI group demonstrated a significantly lower FL muscle activity than the control group. The FAI group also demonstrated a significantly lower FL and SOL MEP than the control group. 
Study 2 (Immediate effect): Active dorsi-flexion ROM were significantly increased after a single session of joint mobilization. There was also a significantly higher cortico-spinal excitability compared to the CG. 
Study 2 (Short term effect): MANOVA indicated significant group by time interactions on self-report function, ankle girth, FL activity and SOL MEP after 4 weeks (p<0.05). The post hoc tests showed significantly decreased ankle girth in MTG compared to TG and CG,decreased FL muscle activity in MTG compared to TG and CG, increased SOL MEP with respect to TG and CG.
Conclusion: Individuals with FAI had a poorer ROM and FL muscle performance during the balance task. The cortical-spinal excitability of the FL and SOL was impaired in those with FAI. This may indicate a potential link between joint instability, muscle control during tasks and the central nervous system. Joint mobilization can restore range of motion and increase neuroplasticity after joint mobilization.

Trial website

Trial related presentations / publications

The study has not published

Public notes

Contacts

Principal investigator

Name

A/Prof 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

Phone

+886 2 2826 7340

Fax

+886 2 2820 1841

yfshih@ym.edu.tw

Contact person for public queries

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

Phone

+886 2 2826 7340

Fax

+886 2 2820 1841

yfshih@ym.edu.tw

Contact person for scientific queries

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

Phone

+886 2 2826 7340

Fax

+886 2 2820 1841

yfshih@ym.edu.tw

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

Source	Title	Year of Publication	DOI
Embase	The effect of additional joint mobilization on neuromuscular performance in individuals with functional ankle instability.	2018	https://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.

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