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

Chang Gung Memorial Hospital30 enrolled

Overview

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.

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Interventions

Botulinum Toxin Type ADRUG

To inject Botulinum toxin type A on the spasticity lower extremity for stroke patients by ultrasounds guidance.

Stretching exerciseOTHER

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.

Eligibility

Sex: ALL

Medical Language ↔ Plain English

Inclusion Criteria: * Patient with spasticity toe clawing(metatarsophalange jointextension, proximal and distal phalange joint flexion) * MAS scale of metatarsophalange joint and interphalangeal joint more than 2 * Pain during walking, abnormal gait patterns and can't wear shoess due to claw toe * Haven't received botox or phenol or alcohol injections before Exclusion Criteria: * Lower extremities joint contrature, bone deformity * Had received botox injections or phenol injections or before due to lower extremities spasticity * Combine other neuromuscular system disease * Severe cognition disorder or aphasia after stroke * Significant atrophy of flexor digitorum longus and brevis * Allergy to botox * Infection on injection site * Have systemic infection * Now accept aminioglycoside or other medicine will affect neuromusclar transition

Locations (1)

Chang Gung Memorial Hospital

Kaohsiung City, Taiwan

Outcomes

Primary Outcomes

Spasticity severity scale

patients will be evaluated at 4 weeks, 8 weeks, 12 weeks, 24 weeks and 1 year after injection 0=none, 1=mild, 2= median, 3=severe