N/A N=30 Randomized Single-blind Treatment

Exoskeleton Robotic Assisted Gait Training in Spastic Stroke Post Botulinum Toxin A Injection

Spastic Gait · Spastic

Bottom Line

View on ClinicalTrials.gov: NCT06070987 ↗

Enrolled (actual)

Serious AEs

—

Results posted

Jan 2026

Primary outcome: Primary: Kinematic Analysis (Including ROM of Each L/E Joints、Change in Gait Speed in Gait Cycle、Change in Center of Mass、Stride Length) — 9; -2; 9; 2 percentage (relative change)

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: BoNT-A injections (Procedure); RF BoNT-A injection in first period and robot therapy (Other); RF BoNT-A injection in second period and robot therapy (Other)
Age: Adult, Older Adult · 20+ yrs
Sex: All
Sponsor: Chang Gung Memorial Hospital
Primary completion: Jul 2025

Outcome Measures

Outcome	Result	p-value
PRIMARY Kinematic Analysis (Including ROM of Each L/E Joints、Change in Gait Speed in Gait Cycle、Change in Center of Mass、Stride Length)	9; -2; 9; 2; 38; -3	—
PRIMARY Data Analysis From the built-in Speed and Angle Sensors of the Exoskeleton Robot (Including ROM of the Joints, the Cyclogram Perimeter, the Cyclogram Area, Cyclogram Orientation, the Trend Symmetry, and the Square Root of the Sum of Squared Deviation	11; 16; 6; 5; -21; 128	—
SECONDARY Modified Emory Functional Ambulation Profile(mEFAP)	-15; -7; -15; -13; -14; -6	—
SECONDARY Modified Ashworth Scale	-5; -5; -12; -11; 0; 0	—
SECONDARY Medical Research Council Scale	4; 5; 16; -4; -1; 0.3	—
SECONDARY Pendulum Test	7; 15; 1; -2; -7; 10	—
SECONDARY Berg Balance Scale	2; 3	—
SECONDARY Six-Minute Walking Test	11; 14	—
SECONDARY Isometric Strength	5; 2; 5; 28; 3; -10	—

Summary

The purpose of this project is to examine and compare the immediate and long-term effects of combined Botulinum toxin type A(BoNT-A) injection with exoskeleton Robotic assisted gait training (RABT) in patients with post-stroke stiff-knee gait.

Eligibility Criteria

Inclusion Criteria

Ischemic or hemorrhagic stroke ≥ 3 months
Age ≥ 20 years
Functional Ambulation Category ≥4
Affected rectus femoris spasticity (MAS between 1+ and 2)
BoNT-A treatment-naive or treated with BoNT-A ≥4 months in the affected leg before recruitment
Receiving oral muscle relaxants or other medication for spasticity were on a stable dose for≥2 months
Can obey simple order

Exclusion Criteria

Pregnant
Sensitivity to BoNT-A
Infection of the skin, soft tissue in the injection area
Participation in other trials
Fixed contractures or bony deformities in the affected leg
Previous treatment of the affected leg with neurolytic or surgical procedures (i.e., phenol block, tendon lengthening of transfer, tenotomy, muscle release, arthrodesis)
Severe cardiovascular comorbidity (i.e., recent myocardial infarction, heart failure, uncontrolled hypertension, orthostatic hypotension)

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT06070987). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.