Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12616000391471
Ethics application status
Approved
Date submitted
19/01/2016
Date registered
24/03/2016
Date last updated
13/09/2016
Type of registration
Retrospectively registered

Titles & IDs
Public title
A Study on Benefit of Circuit Class Therapy on Mobility, Balance, Reintegration into Normal Life and Quality of Life of People with Stroke.
Scientific title
Outcomes of Circuit Class Therapy on Functional Mobility, Balance, Community Reintegration and Quality of Life of Stroke Survivors: Randomised Controlled Trial
Secondary ID [1] 288139 0
NIL
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
STROKE
(Ischaemic or haemorrhagic) 297049 0
Condition category
Condition code
Physical Medicine / Rehabilitation 297273 297273 0 0
Physiotherapy

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The intervention group received CCT focusing on practice of task-oriented activities for 60 – 90 minutes, once a week for total of 12 weeks, CCT exercise components include: aerobic walking, sit to stand, step-up, heel lift, standing with base of support (BOS) constrained, obstacle walking course, tandem walking and task oriented training of upper limb task as its name suggests is an upper limb task. After the completion of all stations, only patients in high function group were given the opportunity to participate in games such as badminton or Ping-Pong. Intensity of the exercise depends on the patient's ability within the allocated 5 minutes for each stations except for aerobic walking exercise which begins with 20 minutes and progressed up 40 minutes by the end of the 12th week.. Intensity performed by patients were recorded and it was ensured that the intensity was progressed every week in terms of number of repetitions, using weights and increasing the complexity level of the task such as counting backward while performing tandem walk.. Therapist administered the treatment in group format of six to eight in each group and participants were given one to two minutes transition time between each stations. Participants were categorized into two sub-groups; low functioning (Modified Rankin Scale of score 3) and high functioning groups (Modified Rankin Scale of score 2 and below). In high functioning group of eight participants, two groups was further formed with one therapist to four patients (1:4). In low functioning group of six participants, two groups with three participants in each group with the ratio of one therapist to three participants (1:3) were formed. Adherence was monitored by maintaining attendance of each patient every session. Patient who failed to attend to the therapy session were followed up by phone calls and a gentle reminder of the next session.
Intervention code [1] 293450 0
Rehabilitation
Comparator / control treatment
The control group received usual therapy administered for 60-90 minutes, once weekly for a total of 12 weeks. Usual therapy was administered in a one to one sessions. Usual therapy was administered by physiotherapists who are experienced in stroke rehabilitation. Patients in the usual therapy received individualized therapy focusing on intervention targeting impairments and the problem presented by the patient. The components of the intervention were based on therapist’s preference and patients’ need. The intervention included electro therapeutic modalities, task specific training and special retraining technique or even basic therapeutic exercise.
Control group
Active

Outcomes
Primary outcome [1] 296855 0
Instrumented Timed Up and Go Test (ITUG)

This study used iTUG with Mobility lab sensors. The operational definition of the mobility in this study focused on gait parameters involving lower limb gait measures and also turning. The definition of categories of lower limb gait measures and turning are described below:

Lower limb gait measures provide data on (1) total duration required to complete the trial (seconds) (2) stride velocity which is the walking speed and measured in percentage of subject’s height / second, (3) stride length which is the distance between two consecutive right and left foot falls measured in percentage of subject’s height (4) gait cycle time which is the duration of a complete gait cycle measured in seconds,(5) double support which is the percentage of a gait cycle that both feet are on the ground measured as percentage of gait cycle time (GCT), (6) swing phase which is average percentage of gait cycle that either foot is off the ground, measured as percentage of GCT, (7) stance phase which is the average percentage of gait cycle that either foot is off the ground measured in percentage of GCT (Ambulatory Parkinson Disease Monitoring APDM 2014).

Turning measures provide data on (1) duration of turning which is the duration of 180 degrees turn, measured according to the mathematical model of turning in seconds, (2) peak turn velocity which is the peak (95 percentage) angular velocity of trunk during turning in seconds, (3) number of steps taken which is defined as number of steps during 180 degrees turn and steps which are at least 50 percentage within turning period and counted in numbers (APDM 2014).

Procedures: Assessors measured 7 meters on the floor and place tape at the two ends. An armless chair was placed at the start end before the tape. ITUG was selected from the sessions tab in the computer, and start trial button was pressed. Participants were instructed to sit comfortably in the chair with their arms on their legs, and back against the seat. When the participants is ready, the button record was pressed and the trial began to count down from 3 seconds.

The participants were instructed to rise from the chair without using their arms and begin walking. After participants crossed the 7m end tape, they will be instructed to turn 180 degrees and walk back. Once they arrived at the chair they should turn 180 degrees, and sit down. Trial was terminated when the patient rests their back against the back of the seat (APDM 2014).
Timepoint [1] 296855 0
Two point of time:

1) Pre intervention (before the beginning of the first session of either CCT or usual therapy), which is after randomisation.

2) Post intervention (after the completion of the treatment, within 7 days or before the beginning of another new therapy independent to the research).
Secondary outcome [1] 319538 0
Berg Balance Scale (BBS)

BBS is a 14-item scale that quantitatively assesses static and dynamic balance of community-dwelling stroke survivors via direct observation of performance of subjects within 10 to 20 minutes. Each items will be scored from 0 to 4, with score 0 representing an inability to complete the task and score of 4 representing independent item completion. Global score is calculated out of 56 points with scores of 0 to 20 representing balance impairment, 21 to 40 representing acceptable balance, and 41 to 56 representing good balance. BBS requires minimal equipment such as chair, stopwatch, ruler, step and space plus no specialized training required.
Timepoint [1] 319538 0
Two point of time:

1) Pre intervention (before the beginning of the first session of either CCT or usual therapy), which is after randomisation.

2) Post intervention (after the completion of the treatment, within 7 days or before the beginning of another new therapy independent to the research).
Secondary outcome [2] 319539 0
Reintegration to Normal Living Index (RNLI)

RNLI comprises of 11 declarative statements that are scored on a 10cm visual analog scale (VAS) and measures the perceived reintegration to normal living of the subjects (Pang et al. 2011). This study required subject to fill the questionnaire as RNLI requires only 10 min and no formal training required to use it (Pang et al. 2011). The RNLI consists 11 items which are of 7 domains which are indoor, community and distance mobility, self-care, daily activities (work and school), recreational and social activities, family role(s), personal relationships and presentation of self to others and general coping skills (Rehab Measures 2014). First 8 items represent 'daily functioning' and the remaining 3 items represent 'perception of self' (Rehab Measures 2014). This study used scoring method of 10 cm visual analog scale in which 0 indicates “does not describe my situation” and 100 indicates “fully describes my situation”. The total score which are sum of all 11 items are divided by 110 and multiplied by 100 for adjusted score
Timepoint [2] 319539 0
Two point of time:

1) Pre intervention (before the beginning of the first session of either CCT or usual therapy), which is after randomisation.

2) Post intervention (after the completion of the treatment, within 7 days or before the beginning of another new therapy independent to the research).
Secondary outcome [3] 319540 0
Health Related Quality of Life (HRQoL)

HRQoL was assessed using EQ-5D-5L which is a validated, self-report, non-disease-specific tool to measure health outcome. EQ-5D-5L is also valid, reliable and responsive in chronic stroke patient and recent study had proven the suitability of employing EQ-5D as outcome measure in neurological clinical trials (Hunger et al. 2012).
The EQ-5D-5L consists of 2 pages - the EQ-5D descriptive system and the EQ visual analogue scale (EQ VAS). The EQ-5D questionnaires consists of five questions which represent five dimensions of HRQoL such as mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each question comes with a single digit response option.
EQ-5D-5L provides five levels of response for each question which are Level 1: indicating no problem, Level 2: indicating slight problems, Level 3: indicating moderate problems, Level 4: indicating severe problems, Level 5: indicating extreme problems. Subjects are only required to tick one option for each question.
The digits for all five questions was combined into a five-digit number describing the respondent’s health state. The EQ-5D has two pages which are the EQ-5D descriptive system and the EQ visual analogue scale (EQ VAS) (EuroQOL Group 2014). This result of EQ-5D-5L health states was converted into a single index value which are presented in country specific value sets. The utility score range between ‘0’ and ‘1’ representing a numeric valuation of the QoL, where ‘0’= death and ‘1’= perfect health. Population utility scores by geographical regions are used based on Thai population (Nor Azlin Mohd Nordin PhD thesis, 2013).
Timepoint [3] 319540 0
Two point of time:

1) Pre intervention (before the beginning of the first session of either CCT or usual therapy), which is after randomisation.

2) Post intervention (after the completion of the treatment, within 7 days or before the beginning of another new therapy independent to the research).

Eligibility
Key inclusion criteria
Inclusion criteria of this study were clinically diagnosed stroke confirmed with computed tomography (CT) scan, scores 3 and less on Modified Rankin Scale (MRS) (score 3: Moderate disability that requires only minimal help and have the ability to walk without physical assistance; score 2; slight disability which causes the inability perform all the previous activities but able to take care of own affair without assistance; score 1: No significant disability which means despite symptoms patient able to carry out activities; score 0: no symptoms), more than one week post stroke onset, ischaemic or haemorrhagic type of stroke, able to provide informed consent
Minimum age
18 Years
Maximum age
80 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Exclusion criteria of this study were score of 16 and above on Center for epidemiology studies-Depression Scale (CES-D which indicates a cut off score and clinical diagnosis of major depression), score of 24 and below on Mini Mental State Exam MMSE, which indicates the presence of cognitive impairment, other medical conditions that precludes participation in the study including aphasia, recent injuries and fractures, past event of myocardial infarction, severe deep vein thrombosis, severe neurological disorder, recent major illness that requires hospitalisation (acute stage), multiple neurological comorbidity, severe musculosketal disorder and stroke patients with mobility condition due to other conditions.

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)
Sealed opaque envelope
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Patients were recruited based on list of patient available in the physiotherapy clinic. Stratified block randomisation were used to randomize patients based on guideline proposed by Doig and Simpson (2005). Stratification was based on age and disability level. Participants were first stratified based on age into two age groups namely below 65 years old and above 65 years old. The second stratification was based on the functional ability measured by Modified Rankin Scale (Score 3: low function group, Score 2 and below: high function group). Therapist independent to the research was asked to pick envelope with the names which fits into each strata.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Main results for each objectives were analysed using Mixed Model ANOVA with SPSS version 20. Gpower version 3.1 was used to calculate sample size. Detailed calculations of the effect size were based on information from previous study by Ko et al (2015), a similar study to the currents study with mean and standard deviation of experimental group are 26.70 +/- 20.9 seconds respectively. The mean and standard deviation of control group are 41.50 +/- 25.30 seconds respectively. The formula for effect size, f calculation for Gpower software version 3.1 was obtained from a paper by Cunningham and Gardner (2007).In Gpower version 3.1, F test, ANOVA repeated measure, within between interactions and effect size of 0.35 were entered into the Gpower version 3.1. Therefore, with alpha value of 0.05 and power of 0.98, a total of 36 patients were needed and this study recruited 40 patients.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
9/03/2015
Date of last participant enrolment
Anticipated
Actual
1/07/2015
Date of last data collection
Anticipated
Actual
1/10/2015
Sample size
Target
36
Accrual to date
Final
40
Recruitment outside Australia
Country [1] 7414 0
Malaysia
State/province [1] 7414 0
KUALA LUMPUR, MALAYSIA

Funding & Sponsors
Funding source category [1] 292547 0
Self funded/Unfunded
Name [1] 292547 0
Sharmila Gopala Krishna Pillai
Country [1] 292547 0
Malaysia
Primary sponsor type
Individual
Name
Nor Azlin Mohd Nordin
Address
Physiotherapy Program, School of Rehabilitation Sciences, Faculty of Health Sciences, Jalan Raja Muda Aziz, Universiti Kebangsaan Malaysia, 50300 Kuala Lumpur, Malaysia .
Country
Malaysia
Secondary sponsor category [1] 291266 0
None
Name [1] 291266 0
Address [1] 291266 0
Country [1] 291266 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 294024 0
Jawatankuasa etika penyelidikan UKM (JEPUKM)
Ethics committee address [1] 294024 0
Sekretariat Etika Penyelidikan Universiti Kebangsaan Malaysia, Tingkat 1, Blok Klinikal, Jalan Yaacob Latif, Bandar Tun Razak, 56000 Cheras Kuala Lumpur. Malaysia
Ethics committee country [1] 294024 0
Malaysia
Date submitted for ethics approval [1] 294024 0
18/12/2014
Approval date [1] 294024 0
06/03/2015
Ethics approval number [1] 294024 0
UKM 1.5.3.5/244/NN-137-2014

Summary
Brief summary
Introduction: Despite the popularity of CCT, there are gaps in knowledge as to whether the intervention improves gait parameters of mobility domain, balance, community reintegration level and quality of life of stroke survivors. Based on the gaps, a research question worth asked is; Is group circuit class therapy effective in improving mobility, balance community reintegration level and health related quality of life of community dwelling stroke survivors? Based on these gaps, primary purpose of the study is to determine the outcomes of circuit class therapy on mobility specifically gait parameters, balance, community reintegration and health related quality of life of community dwelling stroke survivors. This study hypothesis that CCT may improve mobility specifically gait parameters, balance, community reintegration and heath related quality of life among stroke survivors more significantly compared to usual therapy.

Research Design: Assessor blinded Randomized controlled trial (RCT)

Study Site: Rehabilitation Department, University Kebangsaan Malaysia Medical Centre (UKMMC).

Study Population: Community dwelling sub-acute and chronic stroke survivors. Subacute stage of stroke is categorised as above 7 days to 6 months post stroke and chronic stage which exceeds 6 months

Sample Size Calculation: G-power was used to calculate sample size, Total patients recruited were 40.

Recruitment and randomization: Convenience sampling were used to recruit participants. Randomization were performed using sealed opaque envelope using block randomisation method of block of 4 to randomise patients into either intervention group or control group.

Outcome measures: Instrumented Timed Up and Go test (ITUG), Berg Balance Scale (BBS), Reintegration to Normal Living Index (RNLI) and EuroQoL-5-Dimensions

Statistical analysis: Mixed Model ANOVA using SPSS version 20.

RESULTS: The mean age of the participants was 58.68+/-10.12 years. Results shown that there was a significant time effect for TUG score (p=0.009), BBS (p<0.001), community reintegration (p=0.010) and HRQoL (p=0.004). Clinically, greater improvement were observed for iTUG score, community reintegration and HRQoL following CCT compared to usual therapy (mean and standard deviation difference within group); recorded as 4.17 +/- 0.80s versus 1.36 +/- 0.75s, 9.67 +/ -2.03 units versus 2.20+/-2.03 units and 0.13 +/- 0.02 units versus 0.03 +/- 0.03 units respectively. However, no significant group effect were found for all outcome variables (p>0.05). The results shown that CCT is as effective as usual therapy in improving functional mobility, balance, community reintegration and HRQoL.
Trial website
NONE
Trial related presentations / publications
1) First Prize Oral Presentation Winner at International Health Symposium (Isihat) on 11th August 2015 Held in Mines Resort, Malaysia
Presentation Title: Outcomes of Circuit Class Therapy on Mobility, Balance, Community Reintegration and Quality Of Life Of Stroke Survivors: Findings from a Pilot Randomised Controlled Trial

2) Third Prize Winner for Joint Symposium between Thammasat University and Universiti Kebangsaan Malaysia (UKM) Held in UKM, Malaysia on May 27th 2015
Presentation Title: Preliminary Findings of Circuit Class Therapy on Balance, Community Reintegration and Health Related Quality of Life of Stroke Survivors.
Public notes

Contacts
Principal investigator
Name 62174 0
Dr Nor Azlin Mohd. Nordin
Address 62174 0
Physiotherapy Programme, School of Rehabilitation Sciences, Faculty of Health Sciences, Jalan Raja Muda Aziz, Universiti Kebangsaan Malaysia, 50300 Kuala Lumpur, Malaysia .
Country 62174 0
Malaysia
Phone 62174 0
+6019 359 4418, +603 26878038
Fax 62174 0
Email 62174 0
[email protected]
Contact person for public queries
Name 62175 0
Miss Sharmila A/P Gopala Krishna Pillai
Address 62175 0
Organisation: Universiti Kebangsaan Malaysia (UKM)
Address: Physiotherapy Programme, School of Rehabilitation Sciences, Faculty of Health Sciences, Jalan Raja Muda Aziz, Universiti Kebangsaan Malaysia, 50300 Kuala Lumpur, Malaysia .
Country 62175 0
Malaysia
Phone 62175 0
+6010 2486 045
Fax 62175 0
Email 62175 0
[email protected]
Contact person for scientific queries
Name 62176 0
Dr Nor Azlin Mohd.Nordin
Address 62176 0
Physiotherapy Programme, School of Rehabilitation Sciences, Faculty of Health Sciences, Jalan Raja Muda Aziz, Universiti Kebangsaan Malaysia, 50300 Kuala Lumpur, Malaysia .
Country 62176 0
Malaysia
Phone 62176 0
+6019 359 4418, +603 2687 8038
Fax 62176 0
Email 62176 0
[email protected]

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