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Study to see how Botulinum Toxin A can help stroke patients improve their way of walking and reduce tightness of muscles

Role of Botulinum Toxin A in improving Gait and reduction of Spasticity in Stroke survivors: A Randomized Controlled Trial - NIL

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2024/10/075686
Enrollment
16
Registered
2024-10-23
Start date
Unknown
Completion date
Unknown
Last updated
2025-11-17

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

Conditions

Health Condition 1: G811- Spastic hemiplegia

Interventions

Intervention1: Group A Standard Neurorehabilitation along with administration of Injection Botulinum Toxin A in selected spastic muscles: Participants in Group A Patients with hemiplegia following st

Sponsors

All India Institute of Medical Sciences, Raebareli, Uttar Pradesh
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: -Patients with hemiplegia following stroke that has resulted in lower limb spasticity. -Age of the patient between 18 to 80 years. -Spasticity of Grade 2 or Grade 3 according to Modified Ashworth Scale. -No prior Botulinum toxin A injections in the past. -Patient must give consent to take part in the study. -Patient must be under a government funded scheme- such as Ayushman Bharat, CM Fund.

Exclusion criteria

Exclusion criteria: -Significant cognitive impairment. -Significant issues of lower limb including recent fractures/ fixed contractures/ Deep vein thrombosis. -Significant illness- Malignancy. -Pregnancy and lactation. -Uncontrolled Diabetes Mellitus. -Under treatment for any Psychiatric issues (failure to comply and follow up). -Patient not willing to participate.

Design outcomes

Primary

MeasureTime frame
-Walking velocity and Cadence using 10-meter walk test. -Spasticity according to Modified Ashworth Scale (MAS). Timepoint: -Baseline -1 month -3 months -6 months

Secondary

MeasureTime frame
-Timed Up and Go (TUG) test. -Functional independence Measure (FIM). Timepoint: -Baseline -1 month -3 months -6 months

Countries

India

Contacts

Public ContactDr Satyasheel Singh Asthana

All India Institute of Medical Sciences, Raebareli

satyapmr2015@gmail.com9169385726

Outcome results

None listed

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