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

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

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

Conditions
-----------------
Cerebrovascular Accident

Intervention / Treatment
-----------------
* Drug: Botulinum Toxin Type A
* Other: Stretching exercise


Participation Criteria
=================
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
Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Botulinum toxin type A(BTX-A) injection<br>To inject Botulinum toxin type A on the spasticity lower extremities for participants by ultrasounds guidance. | Drug: Botulinum Toxin Type A<br>* To inject Botulinum toxin type A on the spasticity lower extremity for stroke patients by ultrasounds guidance.<br>* Other names: Botulinum toxin;|
| Active Comparator: BTX-A injection plus stretching exercise<br>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. | Drug: Botulinum Toxin Type A<br>* To inject Botulinum toxin type A on the spasticity lower extremity for stroke patients by ultrasounds guidance.<br>* Other names: Botulinum toxin;Other: Stretching exercise<br>* 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.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | Change from Baseline data at 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sensory function scale | patients will be evaluated at 4 weeks, 8 weeks, 12 weeks, 24 weeks and 1 year after injection 0=no feeling, 1=abnormal, 2= normal | Change from Baseline data at 1 year | 
| Brunnstrome stage | patients will be evaluated at 4 weeks, 8 weeks, 12 weeks, 24 weeks and 1 year after injection | Change from Baseline data at 1 year | 
| Manual muscle test | patients will be evaluated at 4 weeks, 8 weeks, 12 weeks, 24 weeks and 1 year after injection including toe flexion/ extension, ankle plantar flexion/ dorsiflexion | Change from Baseline data at 1 year | 
| Functional ambulation classification scale | patients will be evaluated at 4 weeks, 8 weeks, 12 weeks, 24 weeks and 1 year after injection | Change from Baseline data at 1 year | 
| Active range of motion measured by goniometer | patients will be evaluated at 4 weeks, 8 weeks, 12 weeks, 24 weeks and 1 year after injection | Change from Baseline data at 1 year | 
| Modified Ashworth scale(MAS) | patients will be evaluated at 4 weeks, 8 weeks, 12 weeks, 24 weeks and 1 year after injection | Change from Baseline data at 1 year | 
| Pain severity measurement recorded by VAS | patients will be evaluated at 4 weeks, 8 weeks, 12 weeks, 24 weeks and 1 year after injection 0=no pain; 100=maximum | Change from Baseline data at 1 year | 
| To develop a questionnaire (ABILOCO questionnaire) | patients will be evaluated at 4 weeks, 8 weeks, 12 weeks, 24 weeks and 1 year after injection. Its a Rasch-built 13-item questionnaire to assess locomotion ability in stroke patients. | Change from Baseline data at 1 year | 
| Berg Balance test | patients will be evaluated at 4 weeks, 8 weeks, 12 weeks, 24 weeks and 1 year after injection | Change from Baseline data at 1 year | 
| Get up and go test | patients will be evaluated at 4 weeks, 8 weeks, 12 weeks, 24 weeks and 1 year after injection | Change from Baseline data at 1 year | 
| 10-meter walking test | patients will be evaluated at 4 weeks, 8 weeks, 12 weeks, 24 weeks and 1 year after injection | Change from Baseline data at 1 year | 
| Fugl-Meyer Assessment | patients will be evaluated at 4 weeks, 8 weeks, 12 weeks, 24 weeks and 1 year after injection | Change from Baseline data at 1 year | 
| Barthel Index | patients will be evaluated at 4 weeks, 8 weeks, 12 weeks, 24 weeks and 1 year after injection | Change from Baseline data at 1 year | 
| 6 minute walking test | patients will be evaluated at 4 weeks, 8 weeks, 12 weeks, 24 weeks and 1 year after injection | Change from Baseline data at 1 year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
spasticity, claw toe, ultrasounds guidance, botulinum toxin, stretching exercise