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Trial registered on ANZCTR


Registration number
ACTRN12612001228875
Ethics application status
Approved
Date submitted
14/11/2012
Date registered
20/11/2012
Date last updated
23/11/2012
Type of registration
Prospectively registered

Titles & IDs
Public title
The effects of a multimodality balance training on physical and psychological function in stroke survivors: A protocol for a single blinded randomized controlled trial.
Scientific title
The effects of a multimodality balance training compared with conventional balance training on physical and psychological function in stroke survivors.
Secondary ID [1] 281527 0
Nil
Universal Trial Number (UTN)
Nil
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Balance performance 287790 0
Stroke survivors 287819 0
Condition category
Condition code
Stroke 288141 288141 0 0
Ischaemic
Stroke 288142 288142 0 0
Haemorrhagic
Physical Medicine / Rehabilitation 288166 288166 0 0
Other physical medicine / rehabilitation

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Subjects in the intervention group will perform the multimodality balance training. This training incorporates multisensorial training and specific lower limb muscle strength training into a single balance training regime. Intensity of exercises will be modified according to the level of tolerance of subjects. The protocol for the multimodality balance training as follow:

A: Multisensorial training regime in multimodality balance training.

Movements:

1) Stand independently with feet close together. Frequency: Twice per week; Time: 20 secs; Intensity: Time increased 10 secs every week; Sets: 3-4; Progression: To be performed with eyes closed/soft surface.

2) Alternately lift left and right leg during standing on firm surface. Frequency: Twice per week; Repetitions/intensity: 10 reps (Increased by 10 reps every 6 week); Sets: 3-4; Progression: To be performed with eyes closed/soft surface.

3) Touch an object on the floor while standing with feet apart. Frequency: Twice per week; Repetitions/intensity: 10 reps (Increased by 10 reps every 6 week); Sets: 3-4; Progression: To be performed with eyes closed/soft surface with feet close together.

4) Sidewalks forward, right and left alternately on firm surface. Frequency: Twice per week; Repetitions/intensity: 10 reps (Increased by 10 reps every 6 week); Sets: 3-4; Progression: To be performed with eyes closed/soft surface.

5) Walk in a figure of eight formation. Frequency: Twice per week; Repetitions/intensity: 10 reps (Increased by 10 reps every 6 week); Sets: 3-4; Progression: To be performed with eyes closed/soft surface.

6) Walk ahead and make a sharp turn towards right/left. Frequency: Twice per week; Repetitions/intensity: 10 reps (Increased by 10 reps every 6 week); Sets: 3-4; Progression: To be performed with eyes closed/soft surface.

7) Walk ahead crossing over obstacles. Frequency: Twice per week; Repetitions/intensity: 10 reps (Increased by 10 reps every 6 week); Sets: 3-4; Progression: To be performed on a soft surface and to increase the height and number of obstacles.

8) Tandem walking. Frequency: Twice per week; Repetitions/intensity: 10 reps (Increased by 10 reps every 6 week); Sets: 3-4; Progression: To be performed with eyes closed.

9) Sit to stand and walk 10 meter forward. Twice per week; Repetitions/intensity: 10 reps (Increased by 10 reps every 6 week); Sets: 3-4; Progression: To be performed with eyes closed.


B: Specific lower limb training regime in multimodality balance training (with 3 minutes rest intervals between sets).

Movements:

1) Ankle dorsiflexion. Frequency: Twice per week; Repetitions/intensity: 8-10/ 70% of 1 Repetition Maximum (RM). Sets: 3-4; Progression: 1RM to be reassessed biweekly.

2) Ankle plantarflexion. Frequency: Twice per week; Repetitions/intensity: 8-10/ 70% of 1 RM. Sets: 3-4; Progression: 1RM to be reassessed biweekly.

3) Knee extension. Frequency: Twice per week; Repetitions/intensity: 8-10/ 70% of 1 RM. Sets: 3-4; Progression: 1RM to be reassessed biweekly.

4) Knee flexion. Frequency: Twice per week; Repetitions/intensity: 8-10/ 70% of 1 RM. Sets: 3-4; Progression: 1RM to be reassessed biweekly.

5) Hip extension. Frequency: Twice per week; Repetitions/intensity: 8-10/ 70% of 1 RM. Sets: 3-4; Progression: 1RM to be reassessed biweekly.

6) Hip flexion. Frequency: Twice per week; Repetitions/intensity: 8-10/ 70% of 1 RM. Sets: 3-4; Progression: 1RM to be reassessed biweekly.

7) Hip abduction. Frequency: Twice per week; Repetitions/intensity: 8-10/ 70% of 1 RM. Sets: 3-4; Progression: 1RM to be reassessed biweekly.

In the intervention group, subjects will perform both multisensorial training and specific lower limb muscle strength training in a single 60 minutes training session, twice per week for 24 weeks. However, subjects may pause at any time during the training session if feeling tired, dizzy or shortness of breath.
Intervention code [1] 286042 0
Rehabilitation
Comparator / control treatment
Subjects in control group will perform the conventional balance training such as:

1) Step forward, backward, and sideways on the exercise step.

2) Step over blocks of various heights.

3) Stand up from a chair, walk four steps forward, perform a bilateral stool touch and walk backwards to the chair.

4) Stand up from a chair, walk four steps forward, turn to the right, step over the exercise step, turn to the right again and walk forward to the chair (repeat the exercise circuit in the opposite direction).

5) From a sitting position on a 65-cm Swiss ball, perform a range of motion and balance exercises (forward and backward roll of the arms; bend the trunk forward and side to side).

6) Perform a double-legged stance for 10 s.

7) Perform a tandem stance for 10 s.

8) Rise from a chair without the use of the arms.

9) Walk forward and backward with a tandem walking pattern (toes of one foot touches the heel of the foot in front).

10) Perform a single legged stance for 10 s.

In the control group, subjects will engage in conventional balance training twice per week for 24 weeks. Each training session will be approximately 60 minutes in duration. However, subjects may pause at any time during the training session if feeling tired, dizzy or shortness of breath.
Control group
Active

Outcomes
Primary outcome [1] 288343 0
Performance based balance as measured by Berg Balance Scale (BBS).
Timepoint [1] 288343 0
At baseline, week 12, and week 24 post intervention.
Primary outcome [2] 288344 0
Self reported based balance as measured by The Activities-specific Balance Confidence Scale (ABC).
Timepoint [2] 288344 0
At baseline, week 12, and week 24 post intervention.
Secondary outcome [1] 299918 0
Lower limb physical performance as measured using Fugl Meyer Assessment.
Timepoint [1] 299918 0
At baseline, week 12, and week 24 post intervention.
Secondary outcome [2] 299919 0
Specific lower limb muscle strength as measured by 1RM.
Timepoint [2] 299919 0
At baseline, week 12, and week 24 post intervention.
Secondary outcome [3] 299920 0
Functional lower limb muscle strength as measured by 30-Seconds Chair-Rise test.
Timepoint [3] 299920 0
At baseline, week 12, and week 24 post intervention.
Secondary outcome [4] 299921 0
Mobility and dynamic balance as measured by Dynamic Gait Index (DGI).
Timepoint [4] 299921 0
At baseline, week 12, and week 24 post intervention.
Secondary outcome [5] 299922 0
Agility and functional balance as measured by the Timed Up and Go Test (TUG).
Timepoint [5] 299922 0
At baseline, week 12, and week 24 post intervention.
Secondary outcome [6] 299923 0
Level of depression as measured by Beck Depression Inventory (BDI).
Timepoint [6] 299923 0
At baseline, week 12, and week 24 post intervention.
Secondary outcome [7] 299924 0
Level of activities daily living participation as measured by the Barthel Index (BI).
Timepoint [7] 299924 0
At baseline, week 12, and week 24 post intervention.
Secondary outcome [8] 299925 0
Quality of life as measured by the Stroke Specific Quality of Life Scale (SS-QOL).
Timepoint [8] 299925 0
At baseline, week 12, and week 24 post intervention.

Eligibility
Key inclusion criteria
1)Diagnosed as having ischemic or hemorrhagic brain injury which by MRI or computed tomography.

2)More than 6 month after the onset of stroke.

3)BBS scoring less than 41 during baseline.

4)Having high to moderate level of depression which BDI scoring more than 30 during baseline.

5)Able to walk 10 meter without the use of assistive device.

6)Age between 40 to 60 years old.
Minimum age
40 Years
Maximum age
60 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1)Having other neurological disorder other than ischemic or hemorrhagic stroke such as Parkinson disease or cerebellar stroke.

2)Having severe heart disease.

3)Unable to understand command.

4)Undergoing rehabilitation from other institution or personal healthcare provider.

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)
After completion of baseline measurements, subjects will be stratified according to sex so that each group will have equal numbers of male and female. Each subject will be given an opaque envelop which would contain the group of the subjects that they would be assigned to randomly either into the control group or the intervention group. The envelope will be opened after subjects have provided a written consent. The allocation of groups will be blinded to the assessor.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
In this study, stratified allocation will be employed based on gender. In each strata, subjects will be given opaque envelope which contain of random groups allocation (either intervention or control group). The sequence generation for group allocation will be based on simple randomization using a randomization table created by computer software (Random Allocation Software).
Masking / blinding
Blinded (masking 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
Not yet recruiting
Date of first participant enrolment
Anticipated
1/01/2013
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
48
Accrual to date
Final
Recruitment outside Australia
Country [1] 4675 0
Malaysia
State/province [1] 4675 0
Selangor

Funding & Sponsors
Funding source category [1] 286310 0
University
Name [1] 286310 0
Research Intensive Fund
Country [1] 286310 0
Malaysia
Primary sponsor type
Individual
Name
Zoolfaiz Salleh
Address
Physiotherapy Department,
Faculty of Health Sciences,
Universiti Teknologi MARA (UiTM),
Puncak Alam Campus,
42300 Kuala Selangor
Selangor
Country
Malaysia
Secondary sponsor category [1] 285096 0
None
Name [1] 285096 0
Address [1] 285096 0
Country [1] 285096 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 288380 0
Research Ethics Committee Faculty of Health Sciences UiTM
Ethics committee address [1] 288380 0
Ethics committee country [1] 288380 0
Malaysia
Date submitted for ethics approval [1] 288380 0
Approval date [1] 288380 0
11/05/2012
Ethics approval number [1] 288380 0

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

Contacts
Principal investigator
Name 34940 0
Address 34940 0
Country 34940 0
Phone 34940 0
Fax 34940 0
Email 34940 0
Contact person for public queries
Name 18187 0
Zoolfaiz Salleh
Address 18187 0
Physiotherapy Department, Faculty of Health Sciences,
Universiti Teknologi MARA (UiTM), Puncak Alam Campus
42300 Kuala Selangor, Selangor.
Country 18187 0
Malaysia
Phone 18187 0
+60196458011
Fax 18187 0
Email 18187 0
mohdzoolfaiz@gmail.com
Contact person for scientific queries
Name 9115 0
Zoolfaiz Salleh
Address 9115 0
Physiotherapy Department, Faculty of Health Sciences,
Universiti Teknologi MARA (UiTM), Puncak Alam Campus
42300 Kuala Selangor, Selangor.
Country 9115 0
Malaysia
Phone 9115 0
+60196458011
Fax 9115 0
Email 9115 0
mohdzoolfaiz@gmail.com

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

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