Botulinum Toxin Injections by Ultrasounds Guidance and Stretching Exercise in Spastic Toe Clawing

Cerebrovascular Accident Clinical Trial

Official title: Botulinum Toxin Injections by Ultrasounds Guidance and Stretching Exercise in Spastic Toe Clawing

Status Completed

Clinical Trial Summary

Claw toes deformity result in spasticity often seem in patients with central nerve disease. It also cause pressure sore in foot and pain during walking that didn't well improve under traditional treatment. There are few relative reports about the Botulinum toxin type A (BTX-A) injection on claw toe. The investigators' study has two main purposes:

1. assess the efficiency of BTX-A injection under ultrasonographyic guidance on improving lower extremities function, pain and spasticity in patients with symptomatic claw toes.

2. assess if regular stretching exercise can strength the efficiency of BTX-A injection on improving lower extremities function, pain and spasticity.

Clinical Trial Description

The investigators will enroll 50 hemiplegic stroke patients met the inclusion criteria(onset more than 6 month, lower extremity Brunnstrome stage more than stage IV, walking without assistance devices and pain during walking due to claw toe. The investigators will focus and inject BTX-A with ultrasonographyic guidance on flexor digitorum longus and brevis(both 50 unit). If patients combine ankle plantar flexors spasticity, the investigators will inject another 50 unit on both the medial and lateral head of gastrocnemius . Every patients will receive regular stretching exercise in hospital and do self stretching exercise at home for 3 months after injection. Patients will be evaluated at 2 weeks, 4 weeks and 12 weeks, 24 weeks and 1 year after injection. Outcome measure include severity of spasticity and pain, sensory and motor function, range of motion, functional assessment of lower extremity and analyze pressure under foot. ;

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Cerebrovascular Accident
• Stroke

• NCT number: NCT02586142
• Study type: Interventional
• Source: Chang Gung Memorial Hospital
• Status: Completed
• Phase: Phase 3
• Start date: August 2010
• Completion date: July 2013