Clinical trial NCT06070987: Exoskeleton Robotic Assisted Gait Training in Spastic Stroke Post Botulinum Toxin a Injection
Official title: 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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Spastic Gait
Spastic
Keywords: Spasticity
Stroke rehabilitation
Botulinum toxin type A injection
Robot
Knee
Lead sponsor: Chang Gung Memorial Hospital
Sponsor class: OTHER
First posted: 2023-10-06
Enrollment: 36
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Detailed description: The aim of the study is to evaluate the effects of BoNT-A combining with overground exoskeleton robot for patients with post-stroke stiff-knee gait.

Stiff-knee gait (SKG) is a common gait pattern in patients after stroke, characterized by limited knee flexion (KF) during the swing phase of walking. Botulinum toxin A (BoNT-A) injection in rectus femoris muscle is considered the gold standard procedure to treat SKG.

Patients with this gait pattern would reduce walking speed, cause toe dragging, compromise the stability of walking, increase risk of falling, and interfere with daily activities. This randomized controlled trial will contribute to the accelerated refinement and development of efficient and effective treatment programs for patients with post-stroke spastic stiff knee gait. The Robot-assisted gait training (RAGT) has the potential to be an optimal adjunctive therapy following BoNT-A treatment. Combinations of BoNT-A and rehabilitation training are suggested to optimize the treatment effect for spasticity related disabilities.

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)

Primary outcomes:
measure: Modified Emory Functional Ambulation Profile(mEFAP)
timeFrame: Change from baseline at 5 months
Secondary outcomes:
measure: Modified Ashworth scale
timeFrame: Change from baseline at 5 months
measure: Medical Research Council scale
timeFrame: Change from baseline at 5 months
measure: Pendulum test
timeFrame: Change from baseline at 5 months
measure: Berg Balance Scale
timeFrame: Change from baseline at 5 months
measure: Six-Minute Walking Test
timeFrame: Change from baseline at 5 months
measure: Isometric strength
timeFrame: Change from baseline at 5 months
Other outcomes:
measure: Kinematic analysis
timeFrame: Change from baseline at 5 months
measure: Gait Assessment and Intervention Tool
timeFrame: Change from baseline at 5 months
measure: Nottingham Extended Activities of Daily Living Index
timeFrame: Change from baseline at 5 months
measure: Activities-specific Balance confidence
timeFrame: Change from baseline at 5 months
Locations:
city: Kaohsiung
country: Taiwan
facility: Department of Rehabilitation, Chang Gung Memorial Hospital-Kaohsiung Medical Center, Kaohsiung, Taiwan
Study officials:
affiliation: Chang Gung Memorial Hospital-Kaohsiung Medical Center
name: Hung Jen-Wen
role: PRINCIPAL_INVESTIGATOR
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