Chang Gung Memorial Hospital
Kaohsiung City, Taiwan
NCT Number: NCT02586142
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.
Looking for future studies?
Notify MeAll sexes
Interventional
Phase 3
Kaohsiung City, Taiwan
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
To inject Botulinum toxin type A on the spasticity lower extremity for stroke patients by ultrasounds guidance.
Other names: 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.
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
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
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
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
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
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
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
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
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.
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
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
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
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
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
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
Chang Gung Memorial Hospital
Other
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT00210431
Blepharospasm, Brain Damage, Chronic
Agen, France
View Trial DetailsNCT00216411
Brain Diseases, Cardiovascular Diseases
Auburn, New South Wales, Australia
View Trial DetailsNCT00234546
Brain Diseases, Cardiovascular Diseases
Shatin, Hong Kong
View Trial DetailsNCT01153815
Brain Diseases, Cardiovascular Diseases
Guangzhou, Guangdong, China
View Trial Details