Clinical trial NCT02586142: Botulinum Toxin Injections by Ultrasounds Guidance and Stretching Exercise in Spastic Toe Clawing
Official title: Botulinum Toxin Injections by Ultrasounds Guidance and Stretching Exercise in Spastic Toe Clawing
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Cerebrovascular Accident
Keywords: spasticity
claw toe
ultrasounds guidance
botulinum toxin
stretching exercise
Lead sponsor: Chang Gung Memorial Hospital
Sponsor class: OTHER
First posted: 2015-10-26
Enrollment: 30
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Eligibility criteria: 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

Primary outcomes:
measure: Spasticity severity scale
timeFrame: Change from Baseline data at 1 year
Secondary outcomes:
measure: Sensory function scale
timeFrame: Change from Baseline data at 1 year
measure: Brunnstrome stage
timeFrame: Change from Baseline data at 1 year
measure: Manual muscle test
timeFrame: Change from Baseline data at 1 year
measure: Functional ambulation classification scale
timeFrame: Change from Baseline data at 1 year
measure: Active range of motion measured by goniometer
timeFrame: Change from Baseline data at 1 year
measure: Modified Ashworth scale(MAS)
timeFrame: Change from Baseline data at 1 year
measure: Pain severity measurement recorded by VAS
timeFrame: Change from Baseline data at 1 year
measure: To develop a questionnaire (ABILOCO questionnaire)
timeFrame: Change from Baseline data at 1 year
measure: Berg Balance test
timeFrame: Change from Baseline data at 1 year
measure: Get up and go test
timeFrame: Change from Baseline data at 1 year
measure: 10-meter walking test
timeFrame: Change from Baseline data at 1 year
measure: Fugl-Meyer Assessment
timeFrame: Change from Baseline data at 1 year
measure: Barthel Index
timeFrame: Change from Baseline data at 1 year
measure: 6 minute walking test
timeFrame: Change from Baseline data at 1 year
Other outcomes:
Locations:
city: Kaohsiung
country: Taiwan
facility: Chang Gung Memorial Hospital
Study officials:
affiliation: Rehabilitation
name: Pong Ya-Ping, MD
role: STUDY_CHAIR
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