A Study on Benefit of Circuit Class Therapy on Mobility, Balance, Reintegration into Normal Life and Quality of Life of People with Stroke.

• Register: ANZCTR
• Last refreshed on: 13 January 2020
• Main ID: ACTRN12616000391471
• Date of registration: 24/03/2016
• Prospective Registration: No
• Primary sponsor: Nor Azlin Mohd Nordin
• 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
• Date of first enrolment: 09/03/2015
• Target sample size: 36
• Recruitment status: Completed
• URL: https://anzctr.org.au/ACTRN12616000391471.aspx
• Study type: Interventional
• Study design: Purpose: Treatment; Allocation: Randomised controlled trial; Masking: Blinded (masking used);Assignment: Parallel;Type of endpoint: Efficacy;
• Phase: Not Applicable

Countries of recruitment

Malaysia

Contacts

• Name: Miss Sharmila A/P Gopala Krishna Pillai

• Name: Dr Nor Azlin Mohd.Nordin

Key inclusion & exclusion criteria

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
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.


Age minimum: 18 Years
Age maximum: 80 Years
Gender: Both males and females

Health Condition(s) or Problem(s) studied

Physical Medicine / Rehabilitation - Physiotherapy

STROKE (Ischaemic or haemorrhagic);
STROKE
(Ischaemic or haemorrhagic)

Intervention(s)

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 at

Primary Outcome(s)

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).
[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(s)

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.
[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).
]

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).
[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).
]

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
[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 ID(s)

NIL

Source(s) of Monetary Support

Sharmila Gopala Krishna Pillai

Ethics review

Status: Approved
Approval date:
Contact:

Jawatankuasa etika penyelidikan UKM (JEPUKM)