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

Cerebrovascular Accident Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02586142
• Other study ID #: NMRPG890041
• Status: Completed
• Phase: Phase 3
• First received: October 12, 2015
• Last updated: October 23, 2015
• Start date: August 2010
• Est. completion date: July 2013

Study information

• Verified date: August 2010
• Source: Chang Gung Memorial Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Taiwan : Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: July 2013
• Est. primary completion date: July 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

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

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Cerebrovascular Accident
• Stroke

Intervention

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

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.

Locations

Country	Name	City	State
Taiwan	Chang Gung Memorial Hospital	Kaohsiung

Sponsors (1)

Lead Sponsor	Collaborator
Chang Gung Memorial Hospital

Country where clinical trial is conducted

Taiwan, 

References & Publications (26)

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* Note: There are 26 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Spasticity severity scale	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	Change from Baseline data at 1 year	No
Secondary	Sensory function scale	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	Change from Baseline data at 1 year	No
Secondary	Brunnstrome stage	patients will be evaluated at 4 weeks, 8 weeks, 12 weeks, 24 weeks and 1 year after injection	Change from Baseline data at 1 year	No
Secondary	Manual muscle test	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	Change from Baseline data at 1 year	No
Secondary	Functional ambulation classification scale	patients will be evaluated at 4 weeks, 8 weeks, 12 weeks, 24 weeks and 1 year after injection	Change from Baseline data at 1 year	No
Secondary	Active range of motion measured by goniometer	patients will be evaluated at 4 weeks, 8 weeks, 12 weeks, 24 weeks and 1 year after injection	Change from Baseline data at 1 year	No
Secondary	Modified Ashworth scale(MAS)	patients will be evaluated at 4 weeks, 8 weeks, 12 weeks, 24 weeks and 1 year after injection	Change from Baseline data at 1 year	No
Secondary	Pain severity measurement recorded by VAS	patients will be evaluated at 4 weeks, 8 weeks, 12 weeks, 24 weeks and 1 year after injection 0=no pain; 100=maximum	Change from Baseline data at 1 year	No
Secondary	To develop a questionnaire (ABILOCO questionnaire)	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.	Change from Baseline data at 1 year	No
Secondary	Berg Balance test	patients will be evaluated at 4 weeks, 8 weeks, 12 weeks, 24 weeks and 1 year after injection	Change from Baseline data at 1 year	No
Secondary	Get up and go test	patients will be evaluated at 4 weeks, 8 weeks, 12 weeks, 24 weeks and 1 year after injection	Change from Baseline data at 1 year	No
Secondary	10-meter walking test	patients will be evaluated at 4 weeks, 8 weeks, 12 weeks, 24 weeks and 1 year after injection	Change from Baseline data at 1 year	No
Secondary	Fugl-Meyer Assessment	patients will be evaluated at 4 weeks, 8 weeks, 12 weeks, 24 weeks and 1 year after injection	Change from Baseline data at 1 year	No
Secondary	Barthel Index	patients will be evaluated at 4 weeks, 8 weeks, 12 weeks, 24 weeks and 1 year after injection	Change from Baseline data at 1 year	No
Secondary	6 minute walking test	patients will be evaluated at 4 weeks, 8 weeks, 12 weeks, 24 weeks and 1 year after injection	Change from Baseline data at 1 year	No