Botulinum Toxin Injections by Ultrasounds Guidance and Stretching Exercise in Spastic Toe Clawing
Overview
- Phase
- Phase 3
- Intervention
- Botulinum Toxin Type A
- Conditions
- Cerebrovascular Accident
- Sponsor
- Chang Gung Memorial Hospital
- Enrollment
- 30
- Locations
- 1
- Primary Endpoint
- Spasticity severity scale
- Status
- Completed
- Last Updated
- 10 years ago
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.
Investigators
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
Arms & Interventions
Botulinum toxin type A(BTX-A) injection
To inject Botulinum toxin type A on the spasticity lower extremities for participants by ultrasounds guidance.
Intervention: Botulinum Toxin Type A
BTX-A injection plus stretching exercise
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.
Intervention: Botulinum Toxin Type A
BTX-A injection plus stretching exercise
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.
Intervention: Stretching exercise
Outcomes
Primary Outcomes
Spasticity severity scale
Time Frame: 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 Outcomes
- Sensory function scale(Change from Baseline data at 1 year)
- Modified Ashworth scale(MAS)(Change from Baseline data at 1 year)
- Pain severity measurement recorded by VAS(Change from Baseline data at 1 year)
- To develop a questionnaire (ABILOCO questionnaire)(Change from Baseline data at 1 year)
- Brunnstrome stage(Change from Baseline data at 1 year)
- Manual muscle test(Change from Baseline data at 1 year)
- Functional ambulation classification scale(Change from Baseline data at 1 year)
- Active range of motion measured by goniometer(Change from Baseline data at 1 year)
- Berg Balance test(Change from Baseline data at 1 year)
- Get up and go test(Change from Baseline data at 1 year)
- 10-meter walking test(Change from Baseline data at 1 year)
- Fugl-Meyer Assessment(Change from Baseline data at 1 year)
- Barthel Index(Change from Baseline data at 1 year)
- 6 minute walking test(Change from Baseline data at 1 year)