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Effectiveness of botulinum toxin A for patients with lower limb spasticity after stroke: a randomized controlled trial

Effectiveness of botulinum toxin A for patients with lower limb spasticity after stroke: a randomized controlled trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2200062479
Enrollment
Unknown
Registered
2022-08-08
Start date
2022-08-08
Completion date
Unknown
Last updated
2023-04-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Stroke

Interventions

Treatment group:Botulinum toxin A injection treatment,regular rehabilitation
Controlt group:Regular rehabilitation

Sponsors

The First Affiliated Hospital of Nanjing Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
16 Years to 80 Years

Inclusion criteria

Inclusion criteria: 1. Patients with ischemic or hemorrhagic stroke between the ages of 16 and 80 years; 2. Patients with the tone of the lower limb muscle of the spastic side greater than grade 1+ as assessed by the modified Ashworth scale; 3. No previous history of lower limb botulinum toxin injections; 4. Patients with poor results or more severe adverse reactions to oral anticonvulsant drugs; 5. Patients and their family members sign the informed consent form.

Exclusion criteria

Exclusion criteria: 1. Patients who refused to be randomized; 2. Patients with the presence of contracture of the ankle joint; 3. Patients with known contraindications to botulinum toxin type A treatment, such as allergies and the presence of large skin lesions of the area to be injected; 4. Patients with impaired consciousness who are unable to cooperate with botulinum toxin injection treatment; 5. Pregnant and lactating women; 6. Combination of other diseases causing dystonia, such as multiple sclerosis, cerebral palsy, etc; 7. Patients with other serious systemic diseases or clinical critical conditions.

Design outcomes

Primary

MeasureTime frame
The modified Ashworth scale (MAS) score;Fugl-Meyer Assessment Scale (FMA);

Secondary

MeasureTime frame
Berg Balance Scale (BBS) score;Modified Barthel index (MBI) score;Shear wave elastography values;Muscle thickness;10 Meter Walk test (10MWT);

Countries

China

Contacts

Public ContactYe Xinhua

The First Affiliated Hospital of Nanjing Medical University

yexh-0125@163.com+86 025-68303459

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026