Critical Appraisal: Randomized Trial on Orthosis for Stroke Patients

This report critically appraises a randomized controlled trial investigating the effects of early versus delayed provision of ankle-foot orthosis (AFO) in patients with acute and sub-acute stroke. The study, conducted in a rehabilitation center, involved unilateral hemiparetic stroke patients. Participants wer...Read More

Running head: CRITICAL APPRAISAL
CRITICAL APPRAISAL
Name of Student
Name of University
Author note

1
CRITICAL APPRAISAL
Article name: Early or delayed provision of an ankle-foot orthosis in patients with acute and
sub-acute stroke: a randomized controlled trial
The researchers of the study aim to understand the critical aspects of knowledge that
pertains to the use and provision of orthosis such as ankle foot orthosis in the management of
sub-acute and acute stroke patients. The study uses a sample of unilateral hemiparetic stroke
patients in a setting that is a rehabilitation center and uses a randomized control trial in the
design to understand the delayed or early provision of the ankle foot orthosis in the stroke
management process. The participants in the study were randomly divided into two groups –
the group that will have an early provision of orthotic intervention from the first week itself
in comparison to the other group that would have a delayed provision that is about a period of
9 weeks. The clinical outcomes were measured using various scales such as Timed up and Go
test, Barthel Index, stairs test, Functional Ambulation Categories, Rivermead Mobility Index,
10-metre walk test, Timed Up and Go Test, 6-minute walk test, , Berg Balance Scale and this
certain added quality to the research. The findings were correlated to reach a communication
[8].
Methodology
The researchers of this study uses a randomized control trial in order to understand the
difference between the early and the late provision of the ankle foot orthosis in the stroke
management of unilateral hemiparetic stroke management patients. As foot drop is a very
common sign in many cases of the cerebrovascular accident and it is critical to understand
that there is always a chance of contracture development which can be a severe complication
[1]. Hence, in order to manage the same, the orthosis devices are used to support the weak
muscles in the foot area. In order to understand the same, the researchers study uses the right
research design of randomized control trial in which one group of stroke patients are

2
CRITICAL APPRAISAL
administered with early orthotic support and the other group was given the same after 9
weeks. The research design adheres to the research purpose in a critical manner. The
sampling was random as well as added to objectivity of the research and random sampling
eliminated any chance of bias from the scope and content of the article. In the sampling
technique, subjects who are affected with stroke or rather in the post stroke period of 6 weeks
and receiving stroke rehabilitation care plus indicated for ankle foot orthosis for the lack of
foot contact were chosen for the study [2]. The inclusion criteria improved and added much
quality to the research as because the right clinical conditions were chosen only for the
appropriate experimentation. The exclusion criteria were patient with neglect, aphasia or any
kind of cardiac or cardiovascular plus respiratory complications and this is again very
accurate as because including these patients would complicate the main findings of the
research by bringing into calculation, various other scenario that are irrelevant to the research
study [3]. In addition, including these patients would add to the health protection needs and
ethical implications may be raised if these subjects are presented with risks anytime during
the course of the research. Although the research methodology uses a sample size of 16
participants in the early intervention group and 17 participants who are from the delayed
intervention group which means there is not much difference in relation of the group size but
still keeping the validity and reliability of the research in consideration, an equal distribution
of participants should have been better and more appropriate to the research purpose [4]. It is
critical to note that the walk tests and the static plus dynamic balance tests measured the gait,
balance, fatigue, ambulation and mobility of all the participants from both the groups and this
is the strength of the study as because the evaluation of so many outcomes added to the
varied perspectives being measured and employed to understand the research aim and
purpose in a much better manner as well. It is very critical to note and understand each
patient has their individualistic needs that were required to be critically met during the course

3
CRITICAL APPRAISAL
of the research and the design of the research somewhere allowed the safety needs of the
subjects to be met in a proper manner.
Results
The researchers of the study found out that a positive recovery and a huge clinically
significant improvement were seen in the stroke patients group with the early intervention
with ankle foot orthosis in the first 1-3 weeks [5]. It is important to the subjects in the
experimental group showed marked improvement with the clinical and functional and clinical
outcomes with ankle foot orthosis. The evaluation tools other than the Rivermead Mobility
Index and the Functional Ambulation Categories were found to show the positive results.
Conclusions
The researchers of the study concluded saying that the functional outcomes of the
patient as well as the recovery of the patient are improved by the use and application of the
ankle foot orthosis in the symptomatic management of stroke patients in the rehabilitation
centers and an early intervention with the orthotic devices was recommended for a better
treatment of the stroke patient. The static and dynamic balance of the patient during sitting,
sit to stand and standing to walking was improved by the patient.
Clinical implications
The clinical implications were many such as patients who have speech, neglect,
perceptual and neurocognitive deficits may be at risk of falls and lack of supervision with the
use of the ankle foot orthosis might lead to clinical complications [6]. Hence, more
supervision with these patients are required and more so only after an initial recovery, the
ankle foot orthosis will be given so that the subject can learn the necessary skills to use the
same device [7].

4
CRITICAL APPRAISAL
Limitation
The limitation of the study was the researchers of the study did not use educative tools
to help the patient understand the role of the orthotic device and this is where, the risk ratios
were increased.

5
CRITICAL APPRAISAL
References
[1] Kesikburun S, Yavuz F, Güzelküçük Ü, Yaşar E, Balaban B. Effect of ankle foot orthosis
on gait parameters and functional ambulation in patients with stroke. Turkish Journal of
Physical Medicine and Rehabilitation. 2017 Jun;63(2):143.
[2] Berenpas F, Geurts AC, den Boer J, van Swigchem R, Nollet F, Weerdesteyn V. Surplus
value of implanted peroneal functional electrical stimulation over ankle-foot orthosis for gait
adaptability in people with foot drop after stroke. Gait & posture. 2019 Jun 1;71:157-62.
[3] Tyson SF, Vail A, Thomas N, Woodward-Nutt K, Plant S, Tyrrell PJ. Bespoke versus off-
the-shelf ankle-foot orthosis for people with stroke: randomized controlled trial. Clinical
rehabilitation. 2018 Mar;32(3):367-76.
[4] Berenpas, F., Schiemanck, S., Beelen, A., Nollet, F., Weerdesteyn, V. and Geurts, A.,
2018. Kinematic and kinetic benefits of implantable peroneal nerve stimulation in people
with post-stroke drop foot using an ankle-foot orthosis. Restorative neurology and
neuroscience, 36(4), pp.547-558.
[5] Tamburella, F., Moreno, J.C., Iosa, M., Pisotta, I., Cincotti, F., Mattia, D., Pons, J.L. and
Molinari, M., 2017. Boosting the traditional physiotherapist approach for stroke spasticity
using a sensorized ankle foot orthosis: a pilot study. Topics in stroke rehabilitation, 24(6),
pp.447-456.
[6] Kirker S, Tyler A. Bespoke versus off the shelf ankle-foot orthosis for people with stroke:
randomized controlled trial. Clinical rehabilitation. 2018 Oct;32(10):1418-25.
[7] Yeung LF, Ockenfeld C, Pang MK, Wai HW, Soo OY, Li SW, Tong KY. Randomized
controlled trial of robot-assisted gait training with dorsiflexion assistance on chronic stroke

6
CRITICAL APPRAISAL
patients wearing ankle-foot-orthosis. Journal of neuroengineering and rehabilitation. 2018
Dec;15(1):51.
[8]Nikamp CD, Buurke JH, van der Palen J, Hermens HJ, Rietman JS. Early or delayed
provision of an ankle-foot orthosis in patients with acute and subacute stroke: a randomized
controlled trial. Clinical rehabilitation. 2017 Jun;31(6):798-808.