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

October 23, 2015 updated by: Chang Gung Memorial Hospital

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
30

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Taiwan
      • Kaohsiung, Taiwan
        • Chang Gung Memorial Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • ADULT
  • OLDER_ADULT
  • CHILD

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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 Names:
  • 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 Names:
  • 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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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
Change from Baseline data at 1 year

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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
Change from Baseline data at 1 year
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
Change from Baseline data at 1 year
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
Change from Baseline data at 1 year
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
Change from Baseline data at 1 year
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
Change from Baseline data at 1 year
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
Change from Baseline data at 1 year
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
Change from Baseline data at 1 year
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.
Change from Baseline data at 1 year
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
Change from Baseline data at 1 year
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
Change from Baseline data at 1 year
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
Change from Baseline data at 1 year
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
Change from Baseline data at 1 year
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
Change from Baseline data at 1 year
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
Change from Baseline data at 1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Chang Gung Memorial Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

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Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
August 1, 2010

Primary Completion (ACTUAL)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
July 1, 2013

Study Completion (ACTUAL)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 1, 2013

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
October 12, 2015

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 23, 2015

First Posted (ESTIMATE)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
October 26, 2015

Study Record Updates

Last Update Posted (ESTIMATE)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
October 26, 2015

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 23, 2015

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2010

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • NMRPG890041

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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