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Completed

NCT Number: NCT02586142

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

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.

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Botulinum Toxin Type A

Drug

To inject Botulinum toxin type A on the spasticity lower extremity for stroke patients by ultrasounds guidance.

Other names: Botulinum toxin

stretching exercise

Other

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.

Primary outcomes

  1. 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

  1. Sensory function 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=no feeling, 1=abnormal, 2= normal

  2. Brunnstrome stage

    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

  3. Manual muscle test

    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 including toe flexion/ extension, ankle plantar flexion/ dorsiflexion

  4. Functional ambulation classification 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

  5. Active range of motion measured by goniometer

    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

  6. Modified Ashworth scale(MAS)

    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

  7. Pain severity measurement recorded by VAS

    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=no pain; 100=maximum

  8. To develop a questionnaire (ABILOCO questionnaire)

    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.

    Its a Rasch-built 13-item questionnaire to assess locomotion ability in stroke patients.

  9. Berg Balance test

    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

  10. Get up and go test

    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

  11. 10-meter walking test

    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

  12. Fugl-Meyer Assessment

    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

  13. Barthel Index

    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

  14. 6 minute walking test

    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

Sponsors and collaborators

Lead sponsor

Chang Gung Memorial Hospital

Other

Registry information

Important dates

Study start
2010
Primary completion
2013
Study completion
2013
First posted
Oct 26, 2015
Registry last updated
Oct 26, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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