A Randomized Controlled Trial of Distributed Schedule of Robot Assisted Training After Botulinum Toxin Injection in Patient With Spastic Hemiplegic Stroke: Motor Learning Process and Behavioral Outcomes
Phase: NA
Conditions: Stroke, Hemiplegia, Spastic
Sponsor: Chang Gung Memorial Hospital

Condensed and Distributed Robotic Therapy in Spastic Stroke Post Botulinum Toxin 
Injection 
NCT03321097 
Document date Dec, 29, 2016 
 
 

 
Spasticity, a common impairment after stroke, has a profound impact on activity 
and participation for patients. According to the result of our ongoing study, we found 
Botulinum Toxin A (BoNT-A) injection combined with robot-assisted training is 
recommended to enhance functional recovery for patients with spastic hemiplegic 
stroke. However, the optimal program as considering the Robotic Therapy (RT) 
frequency is unknown.  
The aims of this study are to determine and compare the immediate and 
longer-term effects between condensed and distributed programs of RT following 
BoNT-A injection in subjects with spastic hemiplegic stroke. 
Methods 
Participants with stroke will be recruited from a rehabilitation department of 
tertiary referral hospital. Patients who have spastic hemiplegic stroke are screened for 
eligibility to join the study. The inclusion criteria will be: (1) clinical and imagine 
diagnosis of a first or recurrent unilateral stroke ≥ 3 months; (2) upper limb spasticity 
(modified Ashworth scale of ≥ 1+ for elbow flexor and/or forearm pronator and/or 
finger flexor muscles and/or wrist flexor muscles (Bohannon & Smith, 1987); (3) 
initial motor part of UE of FMA score ranging from 12 to 56, indicating moderate to 
severe movement impairment (Duncan, Goldstein, Matchar, Divine, & Feussner, 1992; 
Fugl Meyer, Jaasko, & Leyman, 1975; Park, Wolf, Blanton, Winstein, & 
Nichols-Larsen, 2008); (4) no serious cognitive impairment (i.e., Mini Mental State 
Exam score > 20) (Teng & Chui, 1987); (5) age ≥ 18 years ; and (6) willing to provide 
written informed consent. Participants will be excluded if they are pregnant, or with 
bilateral hemispheric or cerebellar lesions, sever aphasia, significant visual field 
deficits or hemineglect, contraindication for BoNT-A injection, treatment with 
BoNT-A within 4 months before recruitment, any fixed joint contracture of the 
affected upper limb, or a history of orthopedic or other neurological diseases and/or 
medical conditions that would prevent adherence to the rehabilitation protocol. 
Participants with will be recruited and randomly assigned to either condensed or 
distributed RT groups post BoNT-A injection. Each training session included 40 
minutes RT, followed by 40-minute functional training. The condensed group will 
receive 4 sessions per week, for 6 weeks, the distributed group 2 sessions per week, 
for 12 weeks. Body function and structures outcome measures include Fugl-Meyer 
Assessment, Modified Ashworth Scale, actigraphy. Activity and participation 
measures include Wolf Motor Function Test, Motor Activity Log, and Canadian 
Occupational Performance Measure. In addition, to directly reflect a patient’s unique 
needs and goals, Goal Attainment Scaling will be assessed. Evaluators will be blind to 
group allocation. The outcome will be measured at pre-treatment, mid-treatment, 

post-treatment, and 6-week follow-up. 
Data Analysis 
To examine the baseline differences among 2 groups, we use the chi-square test 
and independent-sample t tests to compare participants' baseline characteristics 
between groups. To examine the therapeutic effects of the RT, we use mixed ANOVA 
to test the differences within groups across 4 measurement time points (time effect) 
and to test the differences between groups (condensed intervention group and 
distributed intervention group) and to test interaction effect between time and group. 
Pairwise comparison with Bonferroni adjustments is used to examine the differences 
between measurement time points. All tests are executed using the SPSS software 
version 25 (International Business Machines Corp., Armonk, NY) at the α = .05 level 
of significance.