A Randomized Control Trial to Compare the Effects Between Wearable Robotic System and Robotic Mirror Therapy in Patients With Spastic Hemiplegia Post Botulinum Toxin Injection: Neurophysiological and Behavior Outcomes
Phase: NA
Conditions: Hemiplegia, Spastic, Spastic
Sponsor: Chang Gung Memorial Hospital

Official Title: A Randomized Control Trial to Compare the 
Effects Between Wearable Robotic System and Robotic Mirror 
Therapy in Patients With Spastic Hemiplegia Post Botulinum 
Toxin Injection: Neurophysiological and Behavior Outcomes. 
NCT number: NCT04826900 
Document Date: 2022/03/18 
 
 

Background: 
Botulinum toxin type A (BoNT-A) injection is an effective treatment for upper-
limb spasticity, but lacks in effects on arm-hand capacity. Adding a rehabilitation 
program after BoNT-A injection was suggested as a way to optimize spasticity 
treatment outcomes. However, the optimal adjunct treatment, especially for hand 
function, remains to be established. 
 
Aims:  
This randomized single-blind pilot study aimed to investigate and compare the 
effects between Exoskeletal Robotic Hands therapy (RT) vs Exoskeletal Robotic 
Hands Training Integrating with Mirror Therapy (RMT) after Botulinum Toxin A 
Injection for Post-stroke Spastic Fingers. 
 
Participants 
Participants with stroke were recruited from a rehabilitation department of a 
tertiary referral hospital. Patients who had spastic finger flexors, at least 1+ with the 
Modified Ashworth Scale (MAS) (R. W. Bohannon &amp; M. B. Smith, 1987), 
interfering with hand function, and needed BoNT- A injections, were screened for 
eligibility to join the study. The inclusion criteria were: (1) clinical and imagine 
diagnosis of a first or recurrent unilateral stroke ≥ 6 months; (2) the MAS of finger 
flexors ≥ 1+; (3) initial motor part of UE of FMA score ranging from 10 to 55, 
indicating moderate to severe movement impairment; (4) Mini Mental State Exam 
score ≥ 20; (5) age ≥ 18 years ; and (6) could provide written informed consent. The 
exclusion criteria were (1) bilateral hemispheric or cerebellar lesions; (2) fingers had 
fixed contracture; (3) severe aphasia or cognition impairment; (4) significant visual 
field deficits or hemineglect; (5) treatment with BoNT-A ≤4 months before 
recruitment or (6) history of orthopedic or other neurologic diseases or medical 
conditions that would prevent adherence to the rehabilitation protocol. 
 
Methods: 
A randomization scheme was used to randomize participants. To minimize 
possible confounding effects of upper limb motor ability, we stratified participants 
into groups based on upper limb motor function (FMA UE score: 10-35 or a FMA UE 
score: 35-55) (Pamela W Duncan, Larry B Goldstein, David Matchar, George W Divine, 
&amp; John Feussner, 1992) A person who did not involve the other study 
procedures did the randomization to decide new participants’ group allocation when 
they enrolled, and inform the trainer to conduct their intervention. After BoNT-A 
injection patients were randomly allocated to 2 groups: RT group, and RMT group, 

both groups underwent 24 training sessions (60 minutes /session, 3 sessions/week 
for 8 consecutive weeks). Assessments were performed before training (T0), after 
training (T1), and 3 months after training (T2). The primary outcomes were changes 
in the FMA–Upper Extremity score (FMA–UE, total and distal scores) at T1 from T0. 
The other measures, including Modified Ashworth Scale (MAS), and Medical 
Research Council scale (MRC), Action Research Arm test (ARAT), Box and block test 
(BBT) and Motor Activity Log (MAL) at T1 and all measures at T2 were secondary 
outcomes. 
 
Data Analysis 
The Mann–Whitney U test was used to analyze differences between groups. 
Wilcoxon’s signed-rank test was performed to assess differences in the parameters 
between baseline and post-training points. All tests were executed using the SPSS 
software version 25 (International Business Machines Corp., Armonk, NY) at the α = 
0.05 level of significance.