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Trial registered on ANZCTR


Registration number
ACTRN12617000452392
Ethics application status
Approved
Date submitted
10/01/2017
Date registered
27/03/2017
Date last updated
27/03/2017
Type of registration
Retrospectively registered

Titles & IDs
Public title
Core muscles strengthening for balance and gait performance in individuals with chronic stroke
Scientific title
Core muscles strengthening for balance and gait performance in individuals with chronic stroke
Secondary ID [1] 290878 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Chronic stroke 301590 0
Balance disorder 302375 0
Condition category
Condition code
Physical Medicine / Rehabilitation 301295 301295 0 0
Other physical medicine / rehabilitation
Stroke 301296 301296 0 0
Haemorrhagic
Stroke 301297 301297 0 0
Ischaemic

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Participants will receive 6-weeks core muscle strengthening. Core muscle strengthening contains bracing exercise that is to activate the deeper core muscles particularly which is important components in core muscles strengthening exercises. Bracing exercise are performed by pushing the abdomen out externally. Participants should hold the breath and "brace" abdominal muscles. About the trial, bracing exercise includes bracing with heel slides, bracing with leg lifts, bracing with bridging, quadruped arm lifts with bracing, and quadruped leg lifts with bracing. Participants need to learn how to contract local muscle accurately in those different bracing exercise. If deeper core muscles have been activated, core muscles strengthening can be conducted continually. Exercises have some steps, as follow: (Gymnic Physio Ball will be used in the exercises)
1. Warm-up: participants step on Swiss ball in sitting position for 1 minutes
2. Bridge exercise: hold position for 5 seconds. Perform 10 repetitions for 1 set
3. Bridge exercise with legs crossed, Hold this position for 5 seconds. Perform 10 repetitions for 1 set
4. Bridge exercise with one leg. Hold this position for 3 seconds. Perform 10 repetitions for 1 sets
5. Curl-ups with straight reaching. Hold this position for 3 seconds. Perform 10 repetitions for 1 set
6. Curl-ups with diagonal reaching. Hold this position for 3 seconds. Perform 10 repetitions for 1 set
7. Patient sit on Swiss ball and combine with pelvis anterior tilt. Hold this position for 5 seconds. Perform 15 repetitions for 1 set.
8. Patient sit on Swiss ball and combine with pelvis posterior tilt. Hold this position for 5 seconds. Perform 15 repetitions for 1 set.
9. Supine on Swiss ball with feet on the floor. Hold this position for 10 seconds. Perform 10 repetitions for 1 sets.
10.Patient prone on Swiss ball and combine with trunk extension. Hold this position for 5 seconds. Perform 10 repetitions for 1 sets
11. Cool-down: patient sit on Swiss ball and step on the ball for 1 minutes
Sessions will be delivered by a certificated physiotherapist. Training frequency will be core muscles strengthening for 20 min and treadmill walking training with comfortable speed for 10 min per session, 2 sessions per week for a total of 6 weeks. It will be individual one-on-one sessions taking place in Balance training center in Yang Ming university All participants will be supervised by certified physiotherapist in the exercises program. If participants don't know how to conduct, physiotherapist will use manual contact to teach them. And, demonstrate the repeated exercise.
Intervention code [1] 296824 0
Rehabilitation
Intervention code [2] 296825 0
Treatment: Other
Comparator / control treatment
Control group receive 6-weeks conventional training: . (same format as intervention group except for the exercise component)
1. Lower extremity strengthening
2. Sit to stand
3. Weight shifting to affected lower extremity
4. Stretching ankle plantarflexors
5. Walking training for 10 mins
Participants will be instructed by physiotherapist in individual one-on-one and the sessions are taking place in Balance training center in Yang Ming university. Training frequency will be 30 min per session, 2 sessions per week for a total of 6 weeks.
Control group
Active

Outcomes
Primary outcome [1] 300709 0
Limit of stability by SMART Balance Master, NeuroCom International, Inc., USA
Timepoint [1] 300709 0
Participants will be assessed within one week before and after the 6-week intervention.
Primary outcome [2] 300710 0
Spatial-temporal parameters of gait by GAITRite system
Timepoint [2] 300710 0
Participants will be assessed within one week before and after the 6-week intervention.
Secondary outcome [1] 330667 0
Trunk muslce strength by hand-held dynamometer, Power Track II, Jtech Medical Company, USA
Timepoint [1] 330667 0
Participants will be assessed within one week before and after the 6-week intervention.

Eligibility
Key inclusion criteria
Stroke >6 months
Trunk impairment scale < 23
Can walk > 15 meters independently with or without assistive device
Mini-mental state examination (MMSE) > 24
Brunnstrome stage > IV ( Lower extremity )
Minimum age
20 Years
Maximum age
80 Years
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Have any musculoskeletal problem
Visual, and language problems

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
Recruiting
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment outside Australia
Country [1] 8562 0
Taiwan, Province Of China
State/province [1] 8562 0
Taipei

Funding & Sponsors
Funding source category [1] 295314 0
University
Name [1] 295314 0
National Yang-Ming University
Address [1] 295314 0
No.155, Sec.2, Linong Street, Taipei, 112 Taiwan, R.O.C.
Country [1] 295314 0
Taiwan, Province Of China
Primary sponsor type
University
Name
National Yang-Ming University
Address
No.155, Sec.2, Linong Street, Taipei, 112 Taiwan, R.O.C.
Country
Taiwan, Province Of China
Secondary sponsor category [1] 294138 0
None
Name [1] 294138 0
Address [1] 294138 0
Country [1] 294138 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 296648 0
National Yang-Ming University Office of Research and Development
Ethics committee address [1] 296648 0
National Yang-Ming University, 155, Sec. 2, Li-Nong Street,
Shih-Pai, Taipei, Taiwan.
Ethics committee country [1] 296648 0
Taiwan, Province Of China
Date submitted for ethics approval [1] 296648 0
15/06/2016
Approval date [1] 296648 0
29/07/2016
Ethics approval number [1] 296648 0
YM105062F

Summary
Brief summary
Background and purpose: Core muscles are a key part of our body and play an important role in providing stability for balance and gait. Individuals with stroke often suffer from balance and gait problems even in the chronic stage. Core muscles strengthening exercise has been reported to be beneficial for balance and trunk control. However, few studies investigated core muscles strengthening for the gait symmetry, quantitative dynamic balance performance in chronic stroke patients. Thus, the aim of this study is to investigate the effects of core muscles strengthening in chronic stroke patients for balance performance and gait symmetry.
Methods: This is a single-blinded, randomized controlled trial study. Forty subjects meeting the criteria will be recruited and be randomized to the core muscle strengthening training group or conventional training group. The training for each group will be 30 minutes each time, twice a week for 6 weeks. Primary outcomes include balance performance as indicated by limit of stability, directional control and maximum excursion, measured by Balance Master and gait performance as indicated by gait speed, temporal and spatial symmetry measured by GAITRite system. Secondary outcome include trunk muscle strength measured by dynamometer. All outcomes will be assessed before (pretest) and after (post-test) the 6-week training program.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 71614 0
Miss Chen, Chiao-Ju
Address 71614 0
Department of Physical Therapy and Assistive Technology, National Yang-Ming University
No.155, Sec.2, Linong Street, Taipei, 112 Taiwan, R.O.C.
Country 71614 0
Taiwan, Province Of China
Phone 71614 0
+886-963022715
Fax 71614 0
Email 71614 0
crb81230635@yahoo.com.tw
Contact person for public queries
Name 71615 0
Prof Wang, Ray-Yau
Address 71615 0
Department of Physical Therapy and Assistive Technology, National Yang-Ming University
No.155, Sec.2, Linong Street, Taipei, 112 Taiwan, R.O.C.
Country 71615 0
Taiwan, Province Of China
Phone 71615 0
+886-2-28267210
Fax 71615 0
Email 71615 0
rywang@ym.edu.tw
Contact person for scientific queries
Name 71616 0
Prof Wang, Ray-Yau
Address 71616 0
Department of Physical Therapy and Assistive Technology, National Yang-Ming University
No.155, Sec.2, Linong Street, Taipei, 112 Taiwan, R.O.C.
Country 71616 0
Taiwan, Province Of China
Phone 71616 0
+886-2-28267210
Fax 71616 0
Email 71616 0
rywang@ym.edu.tw

No information has been provided regarding IPD availability
Summary results
No Results