Using robotic assistance to improve walking after stroke treatment with botulinum toxin
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
This study is testing whether combining botulinum toxin injections with robotic walking training can help stroke survivors with stiff-knee gait walk better and feel more comfortable.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 36 (estimated) |
| Ages | 20 Years and up |
| Sex | All |
| Sponsor | Chang Gung Memorial Hospital Academic / other |
| Locations | 1 site (Kaohsiung) |
| Trial ID | NCT06070987 on ClinicalTrials.gov |
What this trial studies
This project aims to evaluate the immediate and long-term effects of combining botulinum toxin type A (BoNT-A) injections with robotic-assisted gait training in patients experiencing stiff-knee gait following a stroke. The study focuses on patients who have had an ischemic or hemorrhagic stroke for at least three months and assesses the effectiveness of this combined approach in enhancing walking ability and reducing spasticity. By comparing outcomes between those receiving both treatments and those receiving only one, the trial seeks to refine rehabilitation strategies for post-stroke patients. The goal is to improve mobility and reduce the risk of falls and other complications associated with stiff-knee gait.
Who should consider this trial
Good fit: Ideal candidates are adults aged 20 and older who have experienced a stroke at least three months prior and exhibit spasticity in the rectus femoris muscle.
Not a fit: Patients who are pregnant, have severe cardiovascular issues, or have undergone previous surgical interventions on the affected leg may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly enhance walking ability and quality of life for stroke survivors with spastic gait.
How similar studies have performed: Other studies have shown promising results with robotic-assisted therapies in rehabilitation, suggesting potential success for this combined approach.
Eligibility criteria
Show full inclusion / exclusion 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)
Where this trial is running
Kaohsiung
- Department of Rehabilitation, Chang Gung Memorial Hospital-Kaohsiung Medical Center, Kaohsiung, Taiwan — Kaohsiung, Taiwan (Recruiting)
Study contacts
- Principal investigator: Hung Jen-Wen — Chang Gung Memorial Hospital-Kaohsiung Medical Center
- Study coordinator: Hung Jen-Wen
- Email: hung0702@cgmh.org.tw
- Phone: +886975056689
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.