NCT02586142

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 30 (actual)
• Sponsor: Chang Gung Memorial Hospital · Academic / Other
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• Cerebrovascular Accident

Interventions

Type	Name	Description
DRUG	Botulinum Toxin Type A	To inject Botulinum toxin type A on the spasticity lower extremity for stroke patients by ultrasounds guidance.
OTHER	Stretching exercise	After accepting Botulinum toxin type A injection, participants will be arranged to receive stretch exercise in Kaohsiung Chang Gung Memorial Hospital 3 times per week, for 3 month.

Timeline

• Start date: 2010-08-01
• Primary completion: 2013-07-01
• Completion: 2013-07-01
• First posted: 2015-10-26
• Last updated: 2015-10-26

Locations

1 site across 1 country: Taiwan