Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12616000218493
Ethics application status
Approved
Date submitted
16/12/2015
Date registered
17/02/2016
Date last updated
22/08/2018
Type of registration
Retrospectively registered

Titles & IDs
Public title
Dancers’ foot and ankle injuries: functional movement screening, neuromuscular performance, and foot and ankle morphology
Scientific title
For young pre-professional dancers with and without ankle and foot injuries, what is the difference of the neuromuscular performance and morphology of the ankle and foot region, and the functional movement screening (FMS) score. And the effectiveness of FMS-based training program on the neuromuscular performance.
Secondary ID [1] 288418 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
ankle and foot injury 297058 0
Condition category
Condition code
Musculoskeletal 297286 297286 0 0
Other muscular and skeletal disorders
Physical Medicine / Rehabilitation 297287 297287 0 0
Other physical medicine / rehabilitation
Injuries and Accidents 297619 297619 0 0
Other injuries and accidents

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
All dancers will receive the following assessment:
Strength and flexibility characteristics: all participants will be examined by a licensed physical therapist, and the following data will be measured: range of motion of the hip, knee and ankle joints, strength and flexibility of the major muscles of the lower extremity .

Functional movement screening (FMS) TM: all participants will perform seven FMS tasks, instructed by a FMS-trained, licensed physical therapist, and be videotaped for scoring. The seven movement tasks are: deep squat, hurdle step, in-line lunge, shoulder mobility, active straight leg raise, trunk stability push-up, rotatory stability.

Neuromuscular control characteristics: the neuromuscular control characteristics of the foot and ankle complex are evaluated by:
Muscle activation pattern of the lower extremity during the FMS tasks. The muscle activity of the lower extremity major muscles will be assessed using an 8-channel FM/FM Telemetric electromyography (EMG) system (Telemyo 900, Noraxon USA, Inc., AZ, USA) during the FMS tasks (deep squat, hurdle step, in-line lunge).

Morphology of the joints of the lower extremity: the orientation of the femoral neck, the relative alignment of the tibia and fibula, and the relative alignment of the talus, calcaneus, navicular, and cuboid bones will be assessed using three-dimensional magnetic resonance imaging (3D-MRI). This item will be assessed in the second year.

All assessments are carried out during a single 3 hour session

In the second year, subjects in the injured group were then randomized to either the FMS-based training group or the control group and received FMS-based training and traditional physical therapy for 4 weeks. The FMS-based training involved squat, hip motor control movements (included training of hip abductor stabilizers, hip adductor stabilizers and hip extensor stabilizers.). The training duration of the intervention was one-on-one face-to-face 1 hour per week for 4 weeks. The intensity of the training program was 10 in a 20-point Borf PRE. And all training program was administered by licensed physical therapist. We checked the situation of intervention by participant diary.
Intervention code [1] 293459 0
Diagnosis / Prognosis
Comparator / control treatment
The healthy, young pre-professional dancers were recruited in this study and received the same assessment as injured group. In order to compare the difference of the neuromuscular performance and morphology of the ankle and foot region, and compare the functional movement screening (FMS) TM score between young pre-professional dancers with and without ankle and foot injuries. In the second part of our study, subjects in control group were received traditional physical therapy and stretch exercises for lower leg.

To assess the effectiveness of FMS-based training, we compared the lower extremity muscle strength and muscle activation between experimental group and control group.
Control group
Active

Outcomes
Primary outcome [1] 296865 0
Functional movement screening (FMS): all participants will perform seven FMS tasks, instructed by a FMS-trained, licensed physical therapist, and be videotaped for scoring. The seven movement tasks are: deep squat, hurdle step, in-line lunge, shoulder mobility, active straight leg raise, trunk stability push-up, rotatory stability.
Timepoint [1] 296865 0
Immediately after the history taking.
Primary outcome [2] 296866 0
The muscle activity of the lower extremity major muscles will be assessed using an 8-channel FM/FM Telemetric electromyography (EMG) system (Telemyo 900, Noraxon USA, Inc., AZ, USA) during the FMS tasks (deep squat, hurdle step, in-line lunge).The target muscles are gluteus maximus, gluteus medius, quadriceps, hamstrings, tibialis anterior, soleus, and fibularis longus.
Timepoint [2] 296866 0
Immediately after the history taking and after 4-week training.
Secondary outcome [1] 319552 0
Muscle strength of the lower extremity will record by a hand-held dynanometer in both lower extremities.
Timepoint [1] 319552 0
After the FMS evaluation and after 4-week training.
Secondary outcome [2] 319553 0
Joint range of motion of the lower extremity measured by hand-held goniometer in both lower extremities
Timepoint [2] 319553 0
After the FMS muscle strength evaluation and after 4-week training.

Eligibility
Key inclusion criteria
The inclusion criteria for injured group include: 1) experienced ankle sprain or injury within a year; 2)age between 15 and 25 years old; 3)major in dance. The inclusion criteria for un-injured groups include: 1)age between 15 and 25 years old; 2)major in dance.
Minimum age
15 Years
Maximum age
25 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
The exclusion criteria for both injured and un-injured groups include lower extremity and lower back injury within 6 week.

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)
numbered containers
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using procedures like coin-tossing and dice-rolling
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


Intervention assignment
Parallel
Other design features
Phase
Type of endpoint/s
Efficacy
Statistical methods / analysis
Two-way repeated measures analysis of variances (ANOVAs) and Two-way repeated measures analysis of covariances (ANCOVAs) were used to examine if the experimental group improved more than the control group after intervention. A statistical significance was set at P < 0.05.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
14/01/2016
Date of last participant enrolment
Anticipated
31/07/2017
Actual
15/10/2017
Date of last data collection
Anticipated
Actual
15/11/2017
Sample size
Target
80
Accrual to date
Final
80
Recruitment outside Australia
Country [1] 7420 0
Taiwan, Province Of China
State/province [1] 7420 0
Taipei

Funding & Sponsors
Funding source category [1] 292557 0
Government body
Name [1] 292557 0
Ministry of science and technology
Country [1] 292557 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] 291277 0
None
Name [1] 291277 0
Nil
Address [1] 291277 0
NIL
Country [1] 291277 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 294033 0
Institutional Review Board of National Yang-Ming University
Ethics committee address [1] 294033 0
Ethics committee country [1] 294033 0
Taiwan, Province Of China
Date submitted for ethics approval [1] 294033 0
Approval date [1] 294033 0
07/07/2015
Ethics approval number [1] 294033 0

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

Contacts
Principal investigator
Name 62090 0
A/Prof Yi-Fen Shih
Address 62090 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 62090 0
Taiwan, Province Of China
Phone 62090 0
+886 2 2826 7340
Fax 62090 0
+886 2 2820 1841
Email 62090 0
[email protected]
Contact person for public queries
Name 62091 0
Yi-Fen Shih
Address 62091 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 62091 0
Taiwan, Province Of China
Phone 62091 0
+886 2 2826 7340
Fax 62091 0
+886 2 2820 1841
Email 62091 0
[email protected]
Contact person for scientific queries
Name 62092 0
Yi-Fen Shih
Address 62092 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 62092 0
Taiwan, Province Of China
Phone 62092 0
+886 2 2826 7340
Fax 62092 0
+886 2 2820 1841
Email 62092 0
[email protected]

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No Supporting Document Provided



Results publications and other study-related documents

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