A Phase 3 interventional study of Botulinum Toxin Type A and Stretching exercise in Cerebrovascular Accident, sponsored by Chang Gung Memorial Hospital. Completed at 1 site in Taiwan. Per ClinicalTrials.gov, last updated 2015-10-26.
Sponsored by Chang Gung Memorial Hospital · Phase 3, Interventional, and Treatment
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:
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.
7,283 studies on the registry are indexed under Stroke; 2,013 are open to participants now.
This study's enrollment of 30 is below the median of 50 across 5,366 interventional studies indexed under Stroke.
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Exclusion Criteria:
To inject Botulinum toxin type A on the spasticity lower extremities for participants by ultrasounds guidance.
Drug: Botulinum Toxin Type A
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 · Other: Stretching exercise
To inject Botulinum toxin type A on the spasticity lower extremity for stroke patients by ultrasounds guidance.
Also known as: Botulinum toxin
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.
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
Time frame: Change from Baseline data at 1 year
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
Time frame: Change from Baseline data at 1 year
Brunnstrome stage
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
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
Time frame: Change from Baseline data at 1 year
Functional ambulation classification scale
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
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
Time frame: Change from Baseline data at 1 year
Modified Ashworth scale(MAS)
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
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
Time frame: Change from Baseline data at 1 year
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.
Time frame: Change from Baseline data at 1 year
Berg Balance test
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
Get up and go test
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-meter walking test
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
Fugl-Meyer Assessment
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
Barthel Index
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
6 minute walking test
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
This study is completed, as verified in Aug 2010. You cannot join it, but the record below documents what was studied.
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Chang Gung Memorial Hospital