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

Primary Purpose

Cerebrovascular Accident

Status
Completed
Phase
Phase 3
Locations
Taiwan
Study Type
Interventional
Intervention
Botulinum Toxin Type A
Stretching exercise
Sponsored by
Chang Gung Memorial Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cerebrovascular Accident focused on measuring spasticity, claw toe, ultrasounds guidance, botulinum toxin, stretching exercise

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Chang Gung Memorial Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Botulinum toxin type A(BTX-A) injection

BTX-A injection plus stretching exercise

Arm Description

To inject Botulinum toxin type A on the spasticity lower extremities for participants by ultrasounds guidance.

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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
Brunnstrome stage
patients will be evaluated at 4 weeks, 8 weeks, 12 weeks, 24 weeks and 1 year after injection
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
Functional ambulation classification scale
patients will be evaluated at 4 weeks, 8 weeks, 12 weeks, 24 weeks and 1 year after injection
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
Modified Ashworth scale(MAS)
patients will be evaluated at 4 weeks, 8 weeks, 12 weeks, 24 weeks and 1 year after injection
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
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.
Berg Balance test
patients will be evaluated at 4 weeks, 8 weeks, 12 weeks, 24 weeks and 1 year after injection
Get up and go test
patients will be evaluated at 4 weeks, 8 weeks, 12 weeks, 24 weeks and 1 year after injection
10-meter walking test
patients will be evaluated at 4 weeks, 8 weeks, 12 weeks, 24 weeks and 1 year after injection
Fugl-Meyer Assessment
patients will be evaluated at 4 weeks, 8 weeks, 12 weeks, 24 weeks and 1 year after injection
Barthel Index
patients will be evaluated at 4 weeks, 8 weeks, 12 weeks, 24 weeks and 1 year after injection
6 minute walking test
patients will be evaluated at 4 weeks, 8 weeks, 12 weeks, 24 weeks and 1 year after injection

Full Information

First Posted
October 12, 2015
Last Updated
October 23, 2015
Sponsor
Chang Gung Memorial Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT02586142
Brief Title
Botulinum Toxin Injections by Ultrasounds Guidance and Stretching Exercise in Spastic Toe Clawing
Official Title
Botulinum Toxin Injections by Ultrasounds Guidance and Stretching Exercise in Spastic Toe Clawing
Study Type
Interventional

2. Study Status

Record Verification Date
August 2010
Overall Recruitment Status
Completed
Study Start Date
August 2010 (undefined)
Primary Completion Date
July 2013 (Actual)
Study Completion Date
July 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Chang Gung Memorial Hospital

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cerebrovascular Accident
Keywords
spasticity, claw toe, ultrasounds guidance, botulinum toxin, stretching exercise

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
30 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Botulinum toxin type A(BTX-A) injection
Arm Type
Experimental
Arm Description
To inject Botulinum toxin type A on the spasticity lower extremities for participants by ultrasounds guidance.
Arm Title
BTX-A injection plus stretching exercise
Arm Type
Active Comparator
Arm 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.
Intervention Type
Drug
Intervention Name(s)
Botulinum Toxin Type A
Other Intervention Name(s)
Botulinum toxin
Intervention Description
To inject Botulinum toxin type A on the spasticity lower extremity for stroke patients by ultrasounds guidance.
Intervention Type
Other
Intervention Name(s)
Stretching exercise
Intervention Description
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 Measure Information:
Title
Spasticity severity scale
Description
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
Time Frame
Change from Baseline data at 1 year
Secondary Outcome Measure Information:
Title
Sensory function scale
Description
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
Time Frame
Change from Baseline data at 1 year
Title
Brunnstrome stage
Description
patients will be evaluated at 4 weeks, 8 weeks, 12 weeks, 24 weeks and 1 year after injection
Time Frame
Change from Baseline data at 1 year
Title
Manual muscle test
Description
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
Time Frame
Change from Baseline data at 1 year
Title
Functional ambulation classification scale
Description
patients will be evaluated at 4 weeks, 8 weeks, 12 weeks, 24 weeks and 1 year after injection
Time Frame
Change from Baseline data at 1 year
Title
Active range of motion measured by goniometer
Description
patients will be evaluated at 4 weeks, 8 weeks, 12 weeks, 24 weeks and 1 year after injection
Time Frame
Change from Baseline data at 1 year
Title
Modified Ashworth scale(MAS)
Description
patients will be evaluated at 4 weeks, 8 weeks, 12 weeks, 24 weeks and 1 year after injection
Time Frame
Change from Baseline data at 1 year
Title
Pain severity measurement recorded by VAS
Description
patients will be evaluated at 4 weeks, 8 weeks, 12 weeks, 24 weeks and 1 year after injection 0=no pain; 100=maximum
Time Frame
Change from Baseline data at 1 year
Title
To develop a questionnaire (ABILOCO questionnaire)
Description
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.
Time Frame
Change from Baseline data at 1 year
Title
Berg Balance test
Description
patients will be evaluated at 4 weeks, 8 weeks, 12 weeks, 24 weeks and 1 year after injection
Time Frame
Change from Baseline data at 1 year
Title
Get up and go test
Description
patients will be evaluated at 4 weeks, 8 weeks, 12 weeks, 24 weeks and 1 year after injection
Time Frame
Change from Baseline data at 1 year
Title
10-meter walking test
Description
patients will be evaluated at 4 weeks, 8 weeks, 12 weeks, 24 weeks and 1 year after injection
Time Frame
Change from Baseline data at 1 year
Title
Fugl-Meyer Assessment
Description
patients will be evaluated at 4 weeks, 8 weeks, 12 weeks, 24 weeks and 1 year after injection
Time Frame
Change from Baseline data at 1 year
Title
Barthel Index
Description
patients will be evaluated at 4 weeks, 8 weeks, 12 weeks, 24 weeks and 1 year after injection
Time Frame
Change from Baseline data at 1 year
Title
6 minute walking test
Description
patients will be evaluated at 4 weeks, 8 weeks, 12 weeks, 24 weeks and 1 year after injection
Time Frame
Change from Baseline data at 1 year

10. Eligibility

Sex
All
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pong Ya-Ping, MD
Organizational Affiliation
Rehabilitation
Official's Role
Study Chair
Facility Information:
Facility Name
Chang Gung Memorial Hospital
City
Kaohsiung
Country
Taiwan

12. IPD Sharing Statement

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

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