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

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ClinicalTrials.gov Identifier: NCT02586142
Recruitment Status : Completed
First Posted : October 26, 2015
Last Update Posted : October 26, 2015
Sponsor:
Information provided by (Responsible Party):
Chang Gung Memorial Hospital

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.

Condition or disease Intervention/treatment Phase
Cerebrovascular Accident Drug: Botulinum Toxin Type A Other: Stretching exercise Phase 3

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Botulinum Toxin Injections by Ultrasounds Guidance and Stretching Exercise in Spastic Toe Clawing
Study Start Date : August 2010
Actual Primary Completion Date : July 2013
Actual Study Completion Date : July 2013

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Botulinum toxin type A(BTX-A) injection
To inject Botulinum toxin type A on the spasticity lower extremities for participants by ultrasounds guidance.
Drug: Botulinum Toxin Type A
To inject Botulinum toxin type A on the spasticity lower extremity for stroke patients by ultrasounds guidance.
Other Name: Botulinum toxin

Active Comparator: 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.
Drug: Botulinum Toxin Type A
To inject Botulinum toxin type A on the spasticity lower extremity for stroke patients by ultrasounds guidance.
Other Name: Botulinum toxin

Other: Stretching 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.




Primary Outcome Measures :
  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 Outcome Measures :
  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



Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02586142


Locations
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Taiwan
Chang Gung Memorial Hospital
Kaohsiung, Taiwan
Sponsors and Collaborators
Chang Gung Memorial Hospital
Investigators
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Study Chair: Pong Ya-Ping, MD Rehabilitation

Publications:

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Responsible Party: Chang Gung Memorial Hospital
ClinicalTrials.gov Identifier: NCT02586142     History of Changes
Other Study ID Numbers: NMRPG890041
First Posted: October 26, 2015    Key Record Dates
Last Update Posted: October 26, 2015
Last Verified: August 2010
Keywords provided by Chang Gung Memorial Hospital:
spasticity
claw toe
ultrasounds guidance
botulinum toxin
stretching exercise
Additional relevant MeSH terms:
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Stroke
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Botulinum Toxins
Botulinum Toxins, Type A
abobotulinumtoxinA
Acetylcholine Release Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Cholinergic Agents
Neurotransmitter Agents
Physiological Effects of Drugs
Neuromuscular Agents
Peripheral Nervous System Agents