Effectiveness of Intelligent Rehabilitation Robot Training System Combined With Repetitive Facilitative Exercise on Upper Limb Motor Function After Stroke: a Randomized Control Trial.
Phase: NA
Conditions: Stroke
Sponsor: Nanjing Mingzhou Rehabilitation Hospital

 
Study Protocol 
 
Effectiveness of Intelligent Rehabilitation Robot 
Training System Combined With Repetitive Facilitative 
Exercise on Upper Limb Motor Function After Stroke: a 
Randomized Control Trial 
 
 
 
 
 
 
 
Registration number : NCT06435624 
Proposed date : June 15, 2024 
 
 
 

Study Start 
June 15, 2024 
Primary Completion 
August 31, 2024 
Study Completion 
August 31, 2024 
Objective 
To investigate the effectiveness of Intelligent robotic-assisted training (IRAT) 
combined with Repetitive facilitative exercise (RFE) on upper limb motor 
function in stroke patients 
Design 
Randomized controlled trial 
Ethical Board 
Medical Ethics Management Committee of Nanjing Mingzhou Rehabilitation 
Hospital 
Approval Number 
NJKF202401001  
Location 
Nanjing Mingzhou Rehabilitation Hospital, 102 Yaohua New Village, Qixia 
District, Nanjing, Jiangsu, China 
Randomization 
Closed envelope method 
Masking 
Single blind design (Outcomes assessor) 
Arms 
IRAT group 
RFE group 
CT group 
Enrollment 
30 
30 
30 
Interventions 
IRAT (30min) + RFE (30min) 
RFE (60min) 
CT (60min) 
Outcome Measures 
Fugl-Meyer assessment for upper extremity 
Active participation proportion 
Trajectory deviation 
Trajectory tracking error 
Inclusion Criteria 
Patients (18 to 74 years old) who suffered a first or Second unilateral stroke; 
Chronic stroke (over 6 months from the onset); 
Obvious upper limb movement disorders (FMA-UE scores from 25 to 42); 
Ability to understand and follow simple directions 
Exclusion Criteria 
Pregnant or lactating; 
Upper extremity contracture, pain, or trauma; 
Perceptual, apraxic, or cognitive deficits that lead to inability to follow verbal 
instructions; 
Unable to maintain sitting posture; 
Cerebellar lesion; 
Clinically unstable medical disorders; 
Inability to provide informed consent 

Statistical analysis 
Sample size calculation: G*power 3.1.9.7 software was used to calculate the 
sample size. Using the FMA-UE scores from a pilot study, we calculated the 
effect size f to be 0.374. With an alpha level of 0.05 and a power of 0.80, the 
total sample size was calculated to be 72. 
Statistical analysis method: SPSS 21.0 software was used to calculate the 
demographic and outcome measures. The Shapiro-Wilk test was used to 
assess the distribution of quantitative variables. Since all variables followed a 
normal distribution, a one-way analysis of variance was performed to 
compare the three groups. For post-hoc test, Bonferroni correction was 
applied when equal variances were assumed, and Tamhane's T2 was used 
when equal variances were not assumed. A paired samples t - test was used 
to compare data before and after the intervention. The chi-square test was 
used to compare qualitative variable. All significance tests were two-tailed, 
with p values <0.05 considered statistically significant.