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

Chang Gung Medical Foundation

Status: Completed

Conditions: Spastic; Spastic Gait

Treatments: Other: RF BoNT-A injection in second period and robot therapy; Procedure: BoNT-A injections; Other: RF BoNT-A injection in first period and robot therapy

Study type: Interventional

Funder types: Other

Identifiers

NCT06070987

NMRPG8N0051

Details and patient eligibility

About

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.

Full 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.

Enrollment: 30 patients

Sex: All

Ages: 20+ years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Single Blind

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30 participants in 2 patient groups

RF BoNT-A injection in first period and robot therapy

Experimental group

Description:

Training session included 40 minutes Robotic Therapy, the group will receive 2 sessions per week, for 12 weeks.

Treatment:

Other: RF BoNT-A injection in first period and robot therapy

Procedure: BoNT-A injections

RF BoNT-A injection in second period and robot therapy

Experimental group

Description:

Training session included 40 minutes Robotic Therapy, the group will receive 2 sessions per week, for 12 weeks.

Treatment:

Procedure: BoNT-A injections

Other: RF BoNT-A injection in second period and robot therapy