Cerebrovascular Accident
Conditions
Keywords
spasticity, claw toe, ultrasounds guidance, botulinum toxin, stretching exercise
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.
Interventions
DRUGBotulinum Toxin Type A
To inject Botulinum toxin type A on the spasticity lower extremity for stroke patients by ultrasounds guidance.
OTHERStretching 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.
Sponsors
Chang Gung Memorial Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Spasticity severity scale | Change from Baseline data at 1 year | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Brunnstrome stage | Change from Baseline data at 1 year | patients will be evaluated at 4 weeks, 8 weeks, 12 weeks, 24 weeks and 1 year after injection |
| Manual muscle test | Change from Baseline data at 1 year | 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 |
| Functional ambulation classification scale | Change from Baseline data at 1 year | patients will be evaluated at 4 weeks, 8 weeks, 12 weeks, 24 weeks and 1 year after injection |
| Active range of motion measured by goniometer | Change from Baseline data at 1 year | patients will be evaluated at 4 weeks, 8 weeks, 12 weeks, 24 weeks and 1 year after injection |
| Modified Ashworth scale(MAS) | Change from Baseline data at 1 year | patients will be evaluated at 4 weeks, 8 weeks, 12 weeks, 24 weeks and 1 year after injection |
| Pain severity measurement recorded by VAS | Change from Baseline data at 1 year | patients will be evaluated at 4 weeks, 8 weeks, 12 weeks, 24 weeks and 1 year after injection 0=no pain; 100=maximum |
| Sensory function scale | Change from Baseline data at 1 year | 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 |
| Berg Balance test | Change from Baseline data at 1 year | patients will be evaluated at 4 weeks, 8 weeks, 12 weeks, 24 weeks and 1 year after injection |
| Get up and go test | Change from Baseline data at 1 year | patients will be evaluated at 4 weeks, 8 weeks, 12 weeks, 24 weeks and 1 year after injection |
| 10-meter walking test | Change from Baseline data at 1 year | patients will be evaluated at 4 weeks, 8 weeks, 12 weeks, 24 weeks and 1 year after injection |
| Fugl-Meyer Assessment | Change from Baseline data at 1 year | patients will be evaluated at 4 weeks, 8 weeks, 12 weeks, 24 weeks and 1 year after injection |
| Barthel Index | Change from Baseline data at 1 year | patients will be evaluated at 4 weeks, 8 weeks, 12 weeks, 24 weeks and 1 year after injection |
| 6 minute walking test | Change from Baseline data at 1 year | patients will be evaluated at 4 weeks, 8 weeks, 12 weeks, 24 weeks and 1 year after injection |
| To develop a questionnaire (ABILOCO questionnaire) | Change from Baseline data at 1 year | 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. |
Countries
Taiwan
Outcome results
None listed