Clinical study of combined mirror and extracorporeal shock wave therapy on upper limb spasticity in poststroke patients.

1. Journal club
Presenter : Ashik Dhakal
Moderator : Mr. Sydney Roshan Rebello

2. Title
Clinical study of combined mirror and extracorporeal shock wave
therapy on upper limb spasticity in poststroke patients.

3. Author : Junyi Guo, Shuyan Qian, Yisu Wang and Aihua Xu
Publication : International Journal of Rehabilitation Research
Publishing year : 2018
Journal impact factor : 0.54
Author impact factor : 0

4. PICO
Population : post-stroke patient, >6 months
Intervention : mirror therapy and extracorporal shockwave therapy
Comparison : mirror therapy, ESWT, MT and ESWT
Outcomes : Fugl–Meyer assessment of upper extremity motor recovery,
Modified Ashworth scale for spasticity assessment.

5. Search strategy : PubMed
Key words used : spasticity, physiotherapy
Boolean logic : AND

6. Abstract
Background : Mirror therapy (MT) is a simple, inexpensive, and patient-
oriented method, helps to reduce phantom sensations and pain caused by
amputation and improve range of motion, speed, and accuracy of arm
movement and function. Extracorporeal shock wave therapy (ESWT) is a new,
reversible, and noninvasive method for the treatment of spasticity after stroke.
Objective : To investigate the therapeutic effect of the combination of mirror
and extracorporeal shock wave therapy on upper limb spasticity in poststroke
patients.

7. Methods :120 patients were randomly assigned into four groups: A, B, C, and
D. All groups received conventional rehabilitation training. Participants in
groups A, B, and C also added MT, ESWT, and a combination of MT and
ESWT.
Results : The differences in the Fugl–Meyer assessment and modified
Ashworth scale scores in group C were significantly greater than those of
group D at all observed time points after treatment and were significantly
greater than those of groups A and B (P < 0.05), but no significant differences
were observed between groups A and B until 12 months.
Conclusion : Upper extremity spasticity was improved by combined mirror and
ESWT

8. Introduction
Stroke has become the major cause of morbidity and mortality, affecting 15
million people worldwide annually, among which 5 million die and another
five million are left permanently disabled.
Stroke survivors experience impaired motor function of the upper limb —
functional limitations and disabilities.
Muscle spasticity following stroke is a common complication and the most
common clinical challenge.

9. According to Lance (1980), Spasticity is a typical component of UMN syndrome
characterised by a velocity-dependent increase in tonic stretch reflexes with
exaggerated tendon jerks resulting in hyper excitability of the stretch reflex.
Acc to Watkins et al., 2002, 12 million people have spasticity of the upper or lower
limb globally.
It occurs in 19 and 39% at 3 and 12 months after stroke, respectively.
Spasticity seriously affects important functions of daily living, causing discomfort,
stiffness, and limitations in physical activities and daily life.
Leads to increased medical bills.
Therefore, control and treatment of spasticity have become increasingly important.

10. Mirror therapy is a simple, inexpensive, and patient-oriented method.
First introduced by Ramachandran et al. (1995), shown to reduce phantom
sensations and pain caused by amputation.
Stroke survivals by Altschuler et al for improving hand function.
Zeng et al., 2018, Found helpful in improving range of motion, speed, and
accuracy of arm movement and function.
Suggested as a promising rehabilitation approach upper limb function in post-
stroke patients.

11. Extracorporeal shock wave therapy (ESWT) is a new, reversible, and
noninvasive method for the treatment of spasticity after stroke (Moon et al.,
2013).
ESWT is used in treating spasticity and improving some parameters without
causing muscle weakness or unpleasant effects in patients with stroke, cerebral
palsy, and multiple sclerosis.

12. Both are promising and effective methods for motor recovery of upper limb
spasticity in poststroke patients.
Hypothesis of the study:
MT in combination with ESWT could lead to greater improvement of
spasticity after stroke.

13. Patients and methods
Study design :
Is a randomized controlled trial, patients were divided into four groups (group
A, n=30; group B, n=30, group C, n=30; group D, n = 30) by random
allocation software.
Patients in all groups received conventional rehabilitation therapy for 30 min
per day, 5/week, for 4 weeks.
The conventional program consisted of exercise therapy, occupational therapy,
and neuro-developmental facilitation techniques.
Patients in groups A, B, and C added MT, ESWT, and MT + ESWT training,
respectively, for 20 min per day, five times a week, for 4 weeks.

14. Participants :
137 post stroke inpatients were recruited for this study, from January 2015 to
December 2017.
Inclusion criteria :
Disease duration >6 months.
MAS score >1 and <4 for the upper limb flexor tension, who can
understand and follow simple verbal instructions were recruited.
Exclusion criteria : no cognitive problems.
120 patients were eligible for the study, were provided informed consent.

15. Intervention :
Group A :
sat on a stool in front of a table with a 30 cm2 mirror, hand placed accordingly.
Patients were asked to move their wrist while simultaneously observing the reflection of the
unaffected hand.
Group B:
2000 shots with a pressure of 2.0–3.0 bar and frequency of 8 Hz were used diffusely for the
intrinsic muscles and flexor digitorum tendon of the hand by an ultrasound pointer guide.
The procedure was within tolerable pain limits.
Group C :
Performed MT and received ESWT in parallel on the wrist extensor of the affected side.

16. Outcome measures :
Fugl–Meyer assessment (FMA) of upper extremity motor recovery :
Modified Ashworth scale (MAS)
All patients in the four groups were examined by the same assessors,
performed before the interventions and 1, 3, 6, and 12 months after the last
interventions.

17. Fugl–Meyer assessment (FMA) of upper extremity motor recovery :
FMA, quantitatively measures motor recovery after stroke, has impressive
test–retest and inter-rater reliability and validity.
The score for the motor skill assessment included 66 and 34 points for the
affected upper and lower limbs, respectively, UL was assessed.
A three-point ordinal scale (0, cannot perform; 1, perform partially; 2,
perform completely).

20. Modified Ashworth scale (MAS)
Is a six-point rating scale with scores ranging from 0 to 4, where 0 indicates no
increase in muscle tone and four indicates that the affected limb is rigid during
flexion or extension.
Has good inter-rater and intra-rater reliability.

21. Statistical analysis
Data in this study were analyzed by SPSS 18.0.
Independent t-test, and Mann–Whitney U-test were used as homogeneity tests
for demographic and medical characteristics.
Wilcoxon’s matched-pairs signed ranks test was used to compare results
obtained before and after intervention.
One-way analysis of variance followed by Bonferroni post-hoc tests was used
to compare the differences among the four groups.
Statistical significance was accepted for P values less than 0.05 in all tests.

22. Results
Recruitment and sample size
Patients were recruited between January 2016 and December 2017.
120 patients agreed to participate in the study and were assigned to group A,
B, C, D.
All the participants completed the full protocol.
The 12-month follow-up was completed by all of the patients.
No adverse effects or complications were observed after the interventions in
any of the four groups.

24. There were no significant differences in the demographic and baseline clinical
characteristics of the participants in any of the four groups.

25. Changes in the Fugl–Meyer assessment and modified Ashworth scale of the four group
FMA :
The FMA scores of group C were significantly greater than that of group D at all
observed time points after treatment and were significantly greater than groups A
and B especially at 6 and 12 months, but not until the 12 months.
MAS :
The post-treatment MAS scores were statistically lower in group C than in group D
at all observed time points after treatment and in groups A and B especially at 6 and
12 months.
The differences in MAS scores between groups A and B reached significance at 6
months.

27. Discussion
Present study results showed that MT combined with ESWT produced greater
improvement in upper extremity motor performance and significant reduction in
spasticity, and the effects lasted at least 12 months compared with those of MT
alone or ESWT alone.
This is the first randomized study to investigate the feasibility and possible effects
of MT combined with ESWT for the treatment of upper limb spasticity in
poststroke patients.
Different studies found MT better in improving motor function of the upper
extremity in patients with stroke. (colomer, Gurbuz, Mirela)
The activation of the primary motor cortex (M1) or mirror neurons has been
proposed as the possible mechanism of MT (Garry).

28. ESWT could be used efficiently in the treatment of musculoskeletal disorders
such as chronic tendinopathies, calcific tendinitis of the shoulder, lateral
epicondylitis, and plantar fasciitis. (Gerdesmeyer et al., 2003).
In addition, recent studies have applied ESWT to patients with stroke with
upper or lower limb spasticity and showed that ESWT is effective in treating
spasticity and improving some parameters (Dymarek et al., 2016).

29. Limitations :
First, the small number of participants may affect the generalisability of
the study findings.
Second, FMA and MAS are used to measure motor improvement, but did
not evaluate the Brunnstrom stages of motor recovery.
Thus, further studies, are needed to evaluate the long-term therapeutic benefits
of MT-ESWT on the motor recovery of upper limb spasticity after stroke.

30. Conclusion
The use of MT+ESWT might be beneficial in the recovery of upper limb
spasticity in poststroke patients and could be a promising and effective
method for clinical therapy.

31. PEDro

32. 1. Eligibility criteria were specified
❑ Yes
2. Subjects were randomly allocated to groups (in a crossover study, subjects
were randomly allocated an order in which treatments were received)
❑ Yes
3. Allocation was concealed
❑ No
4. The groups were similar at baseline regarding the most important prognostic
indicators
❑ Yes

33. 5. There was blinding of all subjects
❑ No
6. There was blinding of all therapists who administered the therapy
❑ No
7. There was blinding of all assessors who measured at least one key
outcome
❑ Yes
8. Measures of at least one key outcome were obtained from more than
85% of the subjects initially allocated to groups
❑ Yes

34. 9. All subjects for whom outcome measures were available received the
treatment or control condition as allocated or, where this was not the
case, data for at least one key outcome was analyzed by “intention to
treat”
❑ No
10. The results of between-group statistical comparisons are reported for
at least one key outcome
❑ Yes
11. The study provides both point measures and measures of variability
for at least one key outcome.
❑ Yes

35. PEDro score :6/10

36. Consort

37. 1. TITLE & ABSTRACT
Positive Negative
Structured
abstract given
Not mentioned
as a RCT in the
title

38. 2. INTRODUCTION
Positive Negative
Specific and
explanation of
rationale given
Hypothesis
mentioned

39. 3. METHOD – trial design
Postive Negative
Randomizatio
n mentioned
allocation ratio not
mentioned

40. 4. METHOD- participants
Positive Negative
Eligibility
criteria
mentioned
clearly
Settings and location not
mentioned

41. 5. INTERVENTION
Positive Negative
Description of
intervention is stated
including how and
when it was
administered.

42. 6. OUTCOMES
Positive Negative
Outcome
measures are
clearly mentioned.
Pre and post test
measurements are
clearly mentioned

43. 7. SAMPLE SIZE
Positive Negative
How sample size
was calculated is
not mentioned
Stopping
guidelines not
mentioned

44. 8. RANDOMIZATION
Positive Negative
Method of
Randomisation not
explained

45. 9. ALLOCATION CONCEALMENT
MECHANISM
Positive Negative
Allocation was not
concealed

46. 10.IMPLEMENTATION
Positive Negative
Who generated the
random allocation
sequence not
mentioned

47. 11. BLINDING
Positive Negative
Assessor was
blinded.
Patient and
treating therapist
were not blinded

48. 12. STATISTICAL METHODS
Positive Negative
Statistical methods
is used to compare
groups for outcome
measures

49. 13. RESULTS
Positive negative
Flowchart is given
Participants were randomly
assigned, received intended
treatment, and were
analysed for all outcomes.
No Loses and exclusion
after randomization.

50. 14. RECRUITMENT
Positive Negative
Period of study is
mentioned
Why the trial
ended is not
mentioned

51. 15. BASELINE DATA
Positive Negative
Base line data is
provided for each
group.

52. 16. NUMBERS ANALYSED
Positive Negative
Number of
participants in each
group included in
the analysis.
Analysis by original
assigned group

53. 17. OUTCOMES AND ESTIMATION
Positive Negative
The outcome
measure
calculation per
group clearly
mentioned

54. 18. HARMS
Positive Negative
Not mentioned
about harm

55. 19. DISCUSSION
Positive Negative
Limitation
mentioned
Suggestions for
future researches
is given
Considered other
relevant evidences

56. OTHER - INFORMATION
Positive Negative
Regestration and
trial regestry not
mentioned
Funding is not
mentioned

57. Thank you