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

Chang Gung Medical Foundation

Status and phase: Completed; Phase 3

Conditions: Cerebrovascular Accident

Treatments: Other: Stretching exercise; Drug: Botulinum Toxin Type A

Study type: Interventional

Funder types: Other

Identifiers

NCT02586142

NMRPG890041

Details and patient eligibility

About

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.

Full 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.

Enrollment: 30 patients

Sex: All

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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30 participants in 2 patient groups

Botulinum toxin type A(BTX-A) injection

Experimental group

Description:

To inject Botulinum toxin type A on the spasticity lower extremities for participants by ultrasounds guidance.

Treatment:

Drug: Botulinum Toxin Type A

BTX-A injection plus stretching exercise

Active Comparator group

Description:

Inject Botulinum toxin type A on the spasticity lower extremity for participants by ultrasounds guidance. After injection, arrange them to receive stretching exercise in Kaoshiung Chang Gung Memorial Hospital 3 time per week for 3 months.

Treatment:

Drug: Botulinum Toxin Type A

Other: Stretching exercise