Effect of a Structured Progressive Task-Oriented Circuit Class Training Program With Motor Imagery on Gait Performance in Patients With Stroke: A Randomized Double Blind Balanced Parallel-Group
Phase: NA
Conditions: Stroke, Gait, Hemiplegic
Sponsor: Mahidol University

Study protocol 
 
1.1 
SUMMARY 
Title: 
 
Clinical registration 
no: 
 
Document Date:  
 
Effect of Structured Progressive Task-Oriented Circuit Class Training 
With Motor Imagery on Gait in Stroke 
 
NCT03436810 
 
January 18, 2017 
Study Description: 
Structured Progressive Circuit Class Training (SPCCT) has developed 
on the basis of task-oriented therapy, provides the enriched benefits on 
the patients’ motivation and motor function. Training with the Motor 
Imagery (MI) alone can improve gait performance in patients with 
stroke, but the better effect may observe if combined with the SPCCT. 
Thus, the aim of this study was to investigate the effect of MI with 
SPCCT on gait in patients with stroke. The study involved forty patients 
with stroke from 3 hospitals in Yangon, Myanmar. All participants 
received the 90 min intervention in a session. The experimental group 
received MI with SPCCT and control group received HE with SPCCT 
intervention 3 times a week for 4 weeks. The assessments were taken 
at the baseline, 2 week and 4 weeks after intervention. The outcomes 
measures involved spatio-temporal variables, walking endurance, 
dynamic balance, mobility function and muscle strength. 
 
Objectives:                      
 
General Objective:  To investigate the effect of MI with SPCCT on gait 
performance in patients with stroke  
Specific Objectives: To investigate the spatio-temporal and functional 
gait variables in patients with stroke after receiving MI with SPCCT   
To investigate the spatio-temporal and functional gait variables in 
patients with stroke after receiving HE with SPCCT    
To compare the effect of MI with SPCCT and HE with SPCCT on the 
spatio-temporal and functional gait variables in patients with stroke. 
 
Outcome measures: 
Spatio–temporal variables, walking endurance, dynamic balance, 
mobility function, muscle strength 
 
Study Population: 
Forty patients with stroke, age for experimental group was 49.90 ± 
11.59 years and control group was 55.55 ± 10.74 years, 15 males and 5 
females for experimental group and 11 males and 9 females for control 
group, Mean height for experimental group was 163.89 ± 6.55 
centimeters and control group was 162.03 ± 13.04 centimeters. Mean 
weight for experimental group was 63.65 ± 6.63 kilograms and control 
group was 63.35 ± 13.04 kilograms 
 
Description of 
Sites/Facilities 
Enrolling Participants: 
National Rehabilitation Hospital (NRH), the departments of the Physical 
Medicine and Rehabilitation in North Okkalapa General Hospital 
(NOGH) and East Yangon General Hospital (EYGH), Yangon, Myanmar 
 
Description of Study 
Intervention: 
The experimental group received MI with SPCCT and control group 
received HE with SPCCT intervention 3 times a week for 4 weeks.  
 
Participant Duration: 
4 weeks 
 
 
1.2 
METHODS 
 
Participants 

All participants will be diagnosed as a stroke and will be recruited from the departments of the 
Neuromedical and Physical Medicine and Rehabilitation, Yangon General Hospital (YGH) and the 
National Rehabilitation Hospital (NRH) in Yangon, Myanmar. Eligible participants will be randomly 
allocated into either the experimental or control groups. For allocation of the participants, a computer-
generated list of random number will be used. In order to maintain recruitment balance between groups 
throughout the trial, a permuted block randomization process will be used within each strata using block 
sizes of at least 2 with all blocks divisible by 2. The sequence generation and allocation concealment 
will be managed by the researcher. To prevent inadequate concealment of allocation sequence, 
properly randomizing method using sequentially numbered, opaque sealed envelopes (SNOSE) will 
be used in this study. The allocation envelop will be prepared by using the aluminum foil and 
carbon paper. The aluminum foil will be used to ensure opaque and the allocation sheet inside cannot 
read against the light. The carbon paper will be used to prevent violations of allocation concealment. 
The treatment allocation sheet of standardized-size paper will be fold to fit with envelop. Place 1 sheet 
of carbon paper on top of the folded allocation sheet with the carbon side facing the paper so that writing 
on the front of the envelop is transferred to the treatment allocation paper inside. Then place this carbon 
paper and allocation sheet together inside aluminum foil wrapper. Finally, place complete insert into the 
envelope properly (290). Group assignment will be communicated directly to the therapist for the 
implementation on a single participant basis. In this study, the assessments will be done by the 
researcher. The assessor and the participants will be blinded from the study.  
 
Study Design 
The study design will be a randomized double blind balanced parallel-group (1:1). 
 
1.3 
 SELECTION CRITERIA 
 
Inclusion criteria 
1. First stroke diagnosed by neurologists and has paresis on the unilateral side of the body 
2. Age between 18 and 75 years 
3. Poststroke duration between 3−12 months confirmed by CT report. 
4. Patients with middle cerebral artery (MCA) involvement 
5. Ability to walk at least 10 meters with or without using assistance (walking aid and/or orthosis). 
6. Functional Ambulation Category (FAC) ≥ 3 from the total of 5 score 
7. Good cognition assessing by the Mini Mental State Examination (MMSE) ≥ 24 from the total of 30 
score 
8. National Institutes of Health Stroke Scale (NIHSS) < 14 from the total of 42 score  
9. Proper MI ability assessing by the Kinesthetic and Visual Imagery Questionnaire (KVIQ–10) ≥ 3 
from the total of 5 score  
 
Exclusion criteria 
1. Unstable cardiopulmonary problems (resting heart rate > 120 bpm, resting systolic blood pressure 
> 180 mmHg and resting diastolic blood pressure > 100 mmHg)  
2. Other neurological conditions such as Parkinson's disease, Alzheimer's disease, or epilepsy 
3. Orthopedic and rheumatologic disorders with weight bearing pain  
4. Unable to communicate or unable to follow commands 
5. Serious cardiac conditions such as hospitalization for heart disease within 3 months, active angina, 
serious cardiac arrhythmias, hypertrophic cardiomyopathy, severe aortic stenosis 
6. Patients with unilateral spatial neglect 
7. Patients with ataxic movement 
8. Patients under medications with muscle relaxing effect  
 
Termination Criteria 
1. Borg scale for Rating Perceived Exertion (RPE)  13 from the total of 20 score 
2. Drop in systolic blood pressure 10 mmHg (persistently below baseline), despite an increase in 
workload, when accompanied by any other evidence of ischemia 
3. Central nervous system symptoms such as dizziness, or near syncope 
4. Signs of poor perfusion such as cyanosis or pallor 
5. Severe adverse event, this means falls or incidents leading to injury requiring hospital or general 
practitioner visit 
6. Another episode of stroke  
 

1.4 
 INSTRUMENTATION 
 
Two dimensional gait measurement system compose of; 
1. 8meter walkway 
2. Video camera 
3. Personal computer 
Calibrated ruler 
Stop watch  
Measuring wheel  
Standard armchair (approximately 46 cm in height)  
A 7.5 cm height step 
Sphygmomanometer and stethoscope 
Tape measure 
Hand-held dynamometer 
Oximeter 
Metronome 
 
1.5 
PROCEDURE 
 
All participants will be explained about details of the study and the interventions. After that, they will 
be asked to sign on the written consent approving by the committee of the institution prior to 
participate in study. All participants will be randomly allocated the participants into the experimental 
(SPCCT with MI) or the control (SPCCT with health education) groups. All participants will be 
screened following the criteria and will be collected the demographic data. 
Both groups will receive the same program of SPCCT by physiotherapist who have 5 years 
experienced in neurological condition. Prior to training, tasks will be demonstrated using clear 
instructions. Seven lower extremity mobility tasks will be used in the SPCCT program. The tasks were 
selected from the study of Dean et al and adapted to be appropriate for improving gait function in 
patients with stroke. The trained tasks for the MI will be similar to the tasks in SPCCT to getting the 
transfer effects of training. The experimental group will receive MI training, whereas, the control group 
will receive health education which both will be provided by the researcher. Both groups will be 
matched for duration and frequency of the therapy sessions. 
All outcome measures will be assessed by the therapist who have been trained the outcome 
measures of the study. As the primary outcome measurements, spatio-temporal variables will be 
measured by using two dimensional motion analysis method. The protocol of this method was proved 
to be valid and reliability from previous pilot study. For functional gait variables, six-minute walk test 
will be assessed for determining walking endurance, step test will be assessed for dynamic balance, 
and  Timed Up and Go (TUG) test will be assessed for mobility function.  
As the secondary outcome measure, the strength of hip flexor, hip extensor, knee flexor, knee 
extensor, ankle dorsiflexor, and ankle plantarflexor muscles will be assessed by using hand-held 
dynamometer. Muscle spasticity will be assessed by using the Modified Ashworth Scale (MAS). The 
outcome measures will be assessed at the baseline, after 2 weeks and 4 weeks intervention. For the 
safety, the therapist will measure blood pressure, pulse rate and fatigue level in the assessments, just 
before the training, and rest period during the training program.  
 
1.6 
INTERVENTION PROGRAM 
 
Training schedule for the experimental and control groups 
 
Experimental group 
Duration (min) 
Control group 
Duration (min) 
MI: 
- Relaxation 
- MI practice (Visual) 4 
tasks 
- Rest 
- MI practice 
(Kinesthetic) 4 tasks 
 
3 
 
8.5 
2 
 
8.5 
Health education 
25 

Experimental group 
Duration (min) 
Control group 
Duration (min) 
- Refocusing 
3 
 
25 
 
25 
TOCCT: 
- Warm up 
- TOCCT practice 7 
tasks (4 min practice, 
4 mins rest, 1 min 
transfer in a task) 
 
3 
 
 
 
62 
TOCCT: 
-Warm up 
-TOCCT practice 7 
tasks (4 min practice, 
4 mins rest, 1 min 
transfer in a task) 
 
3 
 
 
 
62 
 
65 
 
65 
Total 
90 
Total 
90 
 
 
MI Training 
The MI practice will be carried out in a quiet room of Physical Medicine and Rehabilitation, NRH clinic. 
In the MI training, there will be familiarization of the MI technique for 2 days in the 1st week and from 
other days of the 1st week up to 4th week, it will be the MI gait training. In MI gait training program, 
there will be 4 phases; 1) the body relaxation and awareness for 3 minutes, 2) visual imagery for 8.5 
minutes, 3) kinesthetic imagery for 8.5 minutes, and 4) refocusing of body and environment for 3 
minute. There will be 2 minutes rest period between the visual imagery and kinesthetic imagery. MI 
training during 4 weeks are described below; 
 
1st week: Familiarization 
The participants will be trained to familiarize with the MI tasks. The participants will be explained 
about the procedures. During the training, they are not supposed to perform the activity but only 
imagine about the tasks. Video will be used together with the explanation to perform and demonstrate 
about the tasks performing. After this session, the participants will perform the tasks physically. Then, 
the participants will be trained with both visual and kinesthetic MI tasks. Imagine the movement using 
the first person perspective both for visual imagery and the kinesthetic imagery. For the visual 
imagery, the participants will be requested to visualize their performing movements from inside of 
their body, as if they are looking through their own eyes while performing the movements. For the 
kinesthetic imagery, the participants will be requested to perceive their body sensations of the 
movements without any movement. During the MI practice, the participants will be asked to (a) avoid 
moving or contracting muscle from their leg, and keep a relaxed position (b) keep their eyes close 
throughout the practice (c) keep track of the number of sequences imagined with their fingers if 
necessary (d) if they lose their concentration during the practice, open their eyes, relax for a few 
moments and then continue the practice of the task. In the tasks of forward and then backward 
stepping tasks, the rhythm will be trained with metronome. In the walking tasks, the participants will 
be asked to walk along the 8 meters walkway and back towards the starting point and repeat the 
walking during the prescribed duration. The participants will be trained until they are able to reproduce 
the tasks correctly demonstrating declarative knowledge of the sequence. 
 
2nd to 4th week Training 
Stage 1: Body Relaxation and Awareness Stage 
The participants will be asked to sit on the chair and the instructions will be given. They may open or 
close their eyes depend on preferring. Therapist will explain about two steps of the exercise. First, 
contraction of particular muscle group in the body. Next, releasing the tension and notice how the 
muscles feel in relaxation. The participants will be asked to contract their muscles when therapist say 
tense your muscle or move your body part, maintain this tension when therapist say hold, release this 
contraction when therapist say relax. Participants will be asked to maintain this relaxation up to the 
end of training. 
 
Stage 2 and 3: Visual and Kinesthetic Imagery 
There will be 4 specific gait MI tasks (Table 3.2). For the stepping task, progression will be provided 
by number of repetitions provided by the rhythm of the metronome. For the walking tasks, progression 
will be increased by the number of walking repetition in the walkway. The practice of the tasks will be 
assigned serially. Each task will be taken for 2 minutes. During the training, number of repetitions will 
be noted after finish the tasks and will be entered into the log-book using as a feedback for the next 

practice session. The engagements of the MI practice will be checked by the pulse rate using the 
oximeter attached to the fingers of the affected hand. The fingers movements of the unaffected hand 
will be recorded for numbers of repetitions of the task completion during imagine. Moreover, during 
the imagery practice, therapist will ask participants to stop imagine unexpectedly and check position 
in the practice. 
 
Training schedule for MI 
MI tasks 
Duration (min) 
1. Stepping forward and backward onto block 
2 
2. Standing up from a chair, walking a short distance (3 m), and returning to the 
chair 
2 
3. Symmetrical walking (8 m) 
2 
4. Walking at fast speed (8 m) 
2 
 
Stage 4: Refocusing of Body and Environment  
The instructions of the MI training according to the stages are described in the following; 
Stages 
Tasks 
Stage 1 
Body relaxation and awareness. 
Stage 2 
Visual imagery 
Task 1. Stepping forward and backward onto blocks; 
1.a Stepping forward and backward onto the block with the unaffected leg 
1.b Stepping forward and backward onto the block with the affected leg 
Task 2. Standing up from a chair, walking a short distance, and returning to 
the chair 
Task 3. Symmetrical walking 
Task 4. Walking at fast speed 
Stage 3 
Kinesthetic imagery 
Task 1. Stepping forward and backward onto blocks 
1.a Stepping forward and backward onto the block with the affected leg 
1.b Stepping forward and backward onto the block with the affected leg 
Task 2. Standing up from a chair, walking a short distance, and returning to 
the chair 
Task 3. Symmetrical walking 
Task 4. Walking at fast speed 
Stage 4 
Refocusing of body and environment. 
 
Health Education (HE) 
For the control group, they will receive25 minutes of health education. The education will be provided 
by the researcher using the documents. One HE topic will take 2 treatment sessions and there will be 
6 topics for the whole intervention period, 4 weeks. The training schedule for health education is 
described. 
Topic 
Duration 
(min) 
Treatment 
session 
Content 
1. Changes 
caused by stroke 
25 
1st and 2nd 
The most common general effects of stroke 
Common changes with a left-brain injury 
Common changes with a right-brain injury 
Common emotional effects of stroke 
Factors on which improvement depends   
2. Complications 
after stroke 
25 
3rd & 4th 
Common complications of stroke 
Treatments for complications after stroke 
3. Emotional 
changes after 
stroke 
25 
5th & 6th 
The way stroke cause emotional changes 
Some common emotional changes after stroke 
The way to cope changing emotion 
4. Living at home 
after stroke 
25 
7th & 8th 
Factors to going home 
Changes to do at home 
5. High blood 
pressure (HBP) 
and stroke 
25 
9th & 10th 
What is HBP? 
HBP and stroke risk 
Persons at higher risk for HBP. 

Topic 
Duration 
(min) 
Treatment 
session 
Content 
6. Preventing 
recurrent stroke 
25 
11th & 12th 
Controllable risk factors 
Uncontrollable risk factors 
Stroke warning signs 
 
SPCCT 
SPCCT program will include 7 different workstations intended to meaningful tasks related to gait 
performance. To get the effect of increasing therapy, it will involve the practice of higher levels of 
functional activities such as standing and walking. The training package will be provided according to 
participant’s condition in terms of muscle strength and mobility status. The practice of the tasks will be 
serial in order. In the training the participants will be in the pairs. The practice will be as the distributed 
pattern. During the rest period of one participants who will observe the performance of partner and 
give encouragement to do the best. Each participant will receive activity log book in which the number 
of repetitions of performance will be entered and it will be used as the feedback in next station. 
Training schedule of SPCCT is described in the following. 
 
SPCCT details 
Duration (min) 
Warm up 
3 
1. Stepping forward-backward onto block 
4 min practice, 4 min rest, 1 min 
transfer (9 min) 
2. Stepping sideway onto block 
9 
3. Heel lifts in standing to strengthen affected planter-flexor 
muscles 
9 
4. Standing with a decreased base and reach for object 
9 
5. Standing up from a chair, walking a short distance, and 
returning to the chair 
9 
6. Symmetrical walking 
9 
7. Walking at fast speed 
8 
Total  
65