Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT04264195 |
| Other study ID # |
CRP.MRS.Iris.2019 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
October 27, 2018 |
| Est. completion date |
March 25, 2020 |
Study information
| Verified date |
March 2021 |
| Source |
Centre for the Rehabilitation of the Paralysed, Bangladesh |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
Each year more than 17 million people in the world are experiencing a stroke. Stroke is a
major cause of mortality and one of the prevalent causes of serious disablement.
Stroke sufferers often will have restricted participation in various domains e.g. not being
able to fulfill the job requirements. That is why they are losing social contacts and are at
risk for social deprivation.
They also show limitations in common daily activities, which implies that they often need
help or must use assistive devices because of muscle weakness, spasticity and impaired
control over one of the hands, which are very common after stroke. Functional hand recovery
will be only minimal at 6 months after stroke in most of the patients. Therefore, patients
mainly rely on their unaffected hand to perform daily activities and refrain from using the
impaired hand. However, it is known that also after a stroke new connection could be made in
the brain when training tasks strenuously. This mechanism is applied in our program by
constraint induced movement therapy (CIMT). In CIMT using the unaffected hand is hindered by
a mitten, so that patients are forced to perform tasks predominantly with the paretic hand.
The original CIMT protocol includes three main elements:
- Constraining of the non-paretic hand to force the use of paretic hand.
- Repetitive task-oriented training of the paretic hand.
- Adherence-enhancing behavioral methods, to promote the use of this technique in the
daily environment.
Although CIMT trials are showing variations in the kind of tasks, the duration of practice
per day and the intensity, they all published significant effects of CIMT compared to
traditional therapy.
Currently CIMT is worldwide considered the most effective rehabilitation treatment for
improving the functioning of the paretic hand in stroke, but this treatment is not applied in
Bangladesh. To overcome this,the investigators have made a protocol for CIMT application with
the purpose to study the effects in stroke patients in the Bangladesh situation.
Method
Beside the CIMT program the investigators also developed a method for getting maximal social
interaction in groups of stroke patients. That may help them to exercise on their own with
support of their peers. The investigators call that a 'peer group regulated training' and
stroke patients got that training in addition to the usual individually focused
rehabilitation. This extra training includes the following elements:
- Stroke patients perform repetitive tasks in a group together (groups 6-8 persons, max
15).
- One of them is assigned as a 'leader', who announces the next task while the therapist
is there mainly for helping and correcting patients.
- Tasks are fine-tuned to the Bangladesh' situation regarding gender-specific clothing,
manipulation of objects and tasks that needs cognitive solutions.
- Within the training there are socializing tasks like singing, sharing of experiences,
complimenting and encouraging each other.
- Patients were asked to perform the tasks by themselves at home as well, and to report
about that.
This method was applied in two separate groups. The group that is indicated as the control
group mainly performed the exercise tasks bilaterally, as in as usual therapy sessions. The
experimental group performed the tasks with forced use of the paretic hand, wearing a mitten
at the non-paretic hand.
The investigators will be compared the performances of the two study groups at the start of
the group therapy, at the finish one month later, and at 3, 6, 9 and 12 months afterwards.
The hypothesis is that the applied adherence-enhancing behavioral method will have dominant
effects, and that the methods: 'bilaterally' versus 'forced use of paretic arm/hand' (CIMT)
will show equal improvements in the short and longer term.
Description:
Research Question. To compare the performances of the experimental and control groups at the
start of the PEPS program, at the finish 1 month later and at 3, 6, 9 and 12 months follow
up.
Hypothesis. Null Hypothesis H0: µ1- µ2 = 0 or μ1=μ2; where μ1= mean of experimental group and
μ2= mean of control group.
PEPS-MIT is not more effective than PEPS-bimanual training in Restoration of upper limb
functioning following stroke.
Alternative Hypothesis Ha: µ1- µ2> 0 or µ1> µ2 PEPS-MIT is more effective than PEPS-bimanual
training in Restoration of upper limb functioning following stroke.
Ethical Considerations. The Bangladesh Health Professions Institute Institutional Review
Board (IRB) judged the ethical issues and they gave the permission for data collection. All
data and assessment files were stored in security and files were maintained with patient data
held anonymously.
All patients were given information about the trial and they were secured that withdrawing
from the trial didn't give any consequences for their normal treatment. All eligible patients
wish to participate and they all signed informed consent forms.
Study design. The study is a double blind randomized clinical trial with baseline assessment,
post-treatment assessment and three-month, 6 months, 9 months and 12 months follow-up, two
group comparison design.
Sample Size. The study sample was all the CRP rehabilitation center patients who meet the
inclusion criteria within the study time frame (10.08.18 to 25.12.18). Total 140 patients
meet the criteria, and all are allocated to the study. Through simple random techniques
patients were allocated into control group and experimental group according to a 1:1 ratio.
Thus, after randomization 70 patient were allocated into control group and 70 were allocated
into experimental group. Sealed envelope was used for randomization that was carried out by
the director of the Spinal Cord Injury Rehabilitation unit of Occupational Therapy
Department. Patients are blinded for the therapy group.
Interventions. The fundamental PEPS-method (Please see PEPS training programme full
description, URL link- https://www.crp-bangladesh.org/standard-treatment-program) was applied
in both the control and experimental group.
The control group mainly performed the exercise tasks bimanually, as in as usual' therapy
sessions (PEPS-bimanual), whereas the experimental group performed the exercise tasks with
forced use of the most affected hand (wearing a specially designed mitten at the non-paretic
hand; PEPS-MIT).
Treatment sessions. Two hours in 5 days per week; Total 4 weeks. Assessments. Trained
assessors who were blinded for the intervention had assessed the functioning of the upper
limb before the start of the treatment, at the end and at follow-up after 3, 6, 9 and 12
months.
Therapists. Therapists were only facilitator of the peer lead training sessions. Six
qualified therapists were randomly (through sealed envelope) allocated to either the
experimental or the control group. Therapists of both groups have got a 7 days training in
the core PEPS program. Both groups of therapists were forbidden to share their training
knowledge with each other as part of study protocol. Therapists are unaware which group is
the control and which is the experimental group: they were blinded for the intervention.
Quality assurance. Pilot trial: Investigators conducted a pilot trial (20 days with 4
patients) before conducting the study for checking feasibility of the program and outcome
measures.
Each session therapist asked the patients for experiencing adverse events, and registered
these.
Monitoring the process of training and data registration regarding the home-exercising was
done during three days each week by the first and third author.
The statistics department of Jahangirnagor University (JU) and MRS program, BHPI, CRP helps
in site monitoring and auditing, and in controlling the accuracy and completeness of the
data, in data validation and registry procedure. All data were checked by Statistics
department of JU and rechecked by MRS program, BHPI, CRP.
Investigators have made a log-book with descriptions of each variable and the normal range of
scores per test, and the codes to indicate the individual patients to keep the patient data
anonymously.
All data were put into SPSS files and checked. Missing data. There are no missing data in
initial assessments.For missing data in follow-up assessments (no show of patients, or
because of passing away of patients) will be used the 'intention-to-treat' analysis.
Statistical analysis: 1. Independent t tests and Chi- Square (χ2) tests will be used to
compare the control and experimental group on sociodemographic and disease variables. Changes
in test scores within each group were evaluated with paired t tests, and between groups with
independent t-test. Repeated measure ANOVA (factorial ANOVA) model will be used to see
whether group differences existed or not and how group scores changes over time and
interaction between Group*Time.
