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

Completed

Phase 3 Results N/A

Trial Description

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.

Conditions

Interventions

  • Botulinum toxin type A Biological
    Other Names: BOTOX®
    Intervention Desc: To inject Botulinum toxin type A on the spasticity lower extremity for stroke patients by ultrasounds guidance.
    ARM 1: Kind: Experimental
    Label: Botulinum toxin type A(BTX-A) injection
    Description: To inject Botulinum toxin type A on the spasticity lower extremities for participants by ultrasounds guidance.
    ARM 2: Kind: Experimental
    Label: BTX-A injection plus stretching exercise
    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.
  • Stretching exercise Other
    Intervention Desc: 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.
    ARM 1: Kind: Experimental
    Label: BTX-A injection plus stretching exercise
    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.

Trial Design

  • Allocation: Randomized
  • Masking: Open Label
  • Purpose: Treatment
  • Intervention: Parallel Assignment

Outcomes

Type Measure Time Frame Safety Issue
Primary Spasticity severity scale Change from Baseline data at 1 year No
Secondary Sensory function scale Change from Baseline data at 1 year No
Secondary Brunnstrome stage Change from Baseline data at 1 year No
Secondary Manual muscle test Change from Baseline data at 1 year No
Secondary Functional ambulation classification scale Change from Baseline data at 1 year No
Secondary Active range of motion measured by goniometer Change from Baseline data at 1 year No
Secondary Modified Ashworth scale(MAS) Change from Baseline data at 1 year No
Secondary Pain severity measurement recorded by VAS Change from Baseline data at 1 year No
Secondary To develop a questionnaire (ABILOCO questionnaire) Change from Baseline data at 1 year No
Secondary Berg Balance test Change from Baseline data at 1 year No
Secondary Get up and go test Change from Baseline data at 1 year No
Secondary 10-meter walking test Change from Baseline data at 1 year No
Secondary Fugl-Meyer Assessment Change from Baseline data at 1 year No
Secondary Barthel Index Change from Baseline data at 1 year No
Secondary 6 minute walking test Change from Baseline data at 1 year No

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