To Estimate the Efficacy of Botulinum Toxin A Injection Combing With Exoskeleton Robotic Assisted Gait Training in Stroke Patients With Spastic Stiff Knee Gait: Motor Function Performance and Neurophysiological Evaluation
Phase: NA
Conditions: Spastic Gait, Spastic
Sponsor: Chang Gung Memorial Hospital

Official Title: To estimate the efficacy of BoNT A injection 
combining with exoskeleton Robotic assisted gait training in 
stroke patients with spastic stiff knee gait: Motor Function 
Performance and Neurophysiological evaluation 
NCT number: NCT06070987 
Document Date: 2025/07/31 
 
 
 
 
 
 
 
 
 
 
 
 
 

Background:  
Stiff-knee gait is a common abnormal gait pattern after stroke, characterized by 
limited knee flexion during the swing phase, which affects walking speed, gait 
symmetry, and participation in daily activities. botulinum toxin (BoNT) injection in 
the rectus femoris is considered a standard treatment; however, studies have shown 
its effects are limited, and it is recommended to combine BoNT injection with 
rehabilitation training. Robot-assisted gait training (RAGT) provides repetitive, task-
oriented gait correction training, but its combined effect with botulinum toxin still 
requires further investigation.  
Aim: 
This study aims to investigate the effect of combining BoNT injection in the 
rectus femoris with exoskeleton robot training on stiff-knee gait in stroke patients.  
Participants: 
Inclusion criteria : We will recruit adult patients with ischemic or hemorrhagic stroke 
for more than 3 months, are able to walk independently with or without device on 
level ground (Functional Ambulation Category ≥4) (Holden et al., 1984) but have 
inadequate of knee flexion during the swing phase. Their affected RF has spasticity 
with the modified Ashworth scale between 1+ and 2. (Rw & Smith, 1987). Patients 
are BoNT‑A treatment-naive or treated with BoNT‑A ≥4 months in the affected leg 
before recruitment. Patients receiving oral muscle relaxants or other medication for 
spasticity were on a stable dose for≥2 months before recruitment. They can obey 
simple order.  
Exclusion criteria : participation in other trials; fixed contractures or bony deformities 
in the affected leg; previous treatment of the affected leg with neurolytic or surgical 
procedures( such as, phenol block, tendon lengthening of transfer, tenotomy, muscle 
release, arthrodesis); severe cardiovascular comorbidity (recent myocardial 
infarction, heart failure, uncontrolled hypertension, orthostatic hypotension), known 
sensitivity to BoNT‑A, had an infection of the skin, soft tissue in the injection area; 
are pregnant. 
Methods:  
A crossover randomized controlled trial design was used. We recruited adult 
patients with ischemic or hemorrhagic stroke for more than 3 months, who were 
able to walk independently with or without device on level ground, but presented 
with spasticity of the knee extensor muscles. And randomly assigned to either an 
early injection group or a delayed injection group. Both groups received six weeks of 
exoskeleton robot-assisted gait training one week after injection (2–3 sessions per 
week, 40 minutes per session, for a total of 12 sessions) and were followed up at 
three months post-training. The injection site was then switched. The data were 

combined according to whether the rectus femoris was injected: injection group 
(Group A) and non-injection group (Group B). The primary outcome was knee 
kinematics, including knee flexion angle and range of motion. Secondary outcomes 
included muscle strength, muscle tone, functional walking ability (6MWT, mEFA), 
balance (BBS), and self-efficacy (ABC, NEADL). 
Analysis and Statistics:  
All data were analyzed using IBM SPSS Statistics version 26.0 for Windows. Prior 
to selecting appropriate statistical tests for continuous variables, the Shapiro-Wilk 
test was conducted to assess the normality of data distribution. For variables 
exhibiting a normal distribution, independent samples t-tests or paired samples t-
tests were applied. For non-normally distributed data, the Mann-Whitney U test or 
the Wilcoxon Signed Rank test was used instead. Treatment outcomes were assessed 
by comparing post-intervention time points with baseline measurements.