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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Botulinum toxin type A(BTX-A) injection | Experimental | To inject Botulinum toxin type A on the spasticity lower extremities for participants by ultrasounds guidance. |
|
| BTX-A injection plus stretching exercise | Active Comparator | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Botulinum Toxin Type A | Drug | To inject Botulinum toxin type A on the spasticity lower extremity for stroke patients by ultrasounds guidance. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Brunnstrome stage |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Pong Ya-Ping, MD | Rehabilitation | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Chang Gung Memorial Hospital | Kaohsiung City | Taiwan |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 12928130 | Background | Yelnik AP, Bonan IV. [Post stroke hemiplegia: lower limb benefit from botulinum toxin (review)]. Ann Readapt Med Phys. 2003 Jul;46(6):281-5. doi: 10.1016/s0168-6054(03)00111-9. French. | |
| 431969 | Background | Rivera-Dominguez M, DiBenedetto M, Frisbie JH, Rossier AB. Pes cavus and claw toes deformity in patients with spinal cord injury and multiple sclerosis. Paraplegia. 1979 Feb;16(4):375-82. doi: 10.1038/sc.1978.71. |
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| ID | Term |
|---|---|
| D020521 | Stroke |
| D009128 | Muscle Spasticity |
| D037801 | Hammer Toe Syndrome |
| ID | Term |
|---|---|
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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| ID | Term |
|---|---|
| D019274 | Botulinum Toxins, Type A |
| D001905 | Botulinum Toxins |
| D052580 | Muscle Stretching Exercises |
| ID | Term |
|---|---|
| D008666 | Metalloendopeptidases |
| D010450 | Endopeptidases |
| D010447 | Peptide Hydrolases |
| D006867 | Hydrolases |
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|
| Stretching exercise | Other | 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. |
|
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 | 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 | 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 | 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) | 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 | 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) | 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 | 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 | 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 | 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 | 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 | 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 | 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 |
| 10790665 | Background | Mizel MS, Yodlowski ML. Disorders of the Lesser Metatarsophalangeal Joints. J Am Acad Orthop Surg. 1995 May;3(3):166-173. doi: 10.5435/00124635-199505000-00006. |
| 11341415 | Background | Feeney MS, Williams RL, Stephens MM. Selective lengthening of the proximal flexor tendon in the management of acquired claw toes. J Bone Joint Surg Br. 2001 Apr;83(3):335-8. doi: 10.1302/0301-620x.83b3.11506. |
| 15147987 | Background | Boulton AJ. Pressure and the diabetic foot: clinical science and offloading techniques. Am J Surg. 2004 May;187(5A):17S-24S. doi: 10.1016/S0002-9610(03)00297-6. |
| 2913002 | Background | Myerson MS, Shereff MJ. The pathological anatomy of claw and hammer toes. J Bone Joint Surg Am. 1989 Jan;71(1):45-9. |
| 7955636 | Background | Truckenbrodt H, Hafner R, von Altenbockum C. Functional joint analysis of the foot in juvenile chronic arthritis. Clin Exp Rheumatol. 1994 Sep-Oct;12 Suppl 10:S91-6. |
| 3366427 | Background | Cyphers SM, Feiwell E. Review of the Girdlestone-Taylor procedure for clawtoes in myelodysplasia. Foot Ankle. 1988 Apr;8(5):229-33. doi: 10.1177/107110078800800501. |
| 4067859 | Background | Bernbach EH, Bernbach MR. A box joint arthrodesis for the proximal interphalangeal joint in claw toe deformity. J Am Podiatr Med Assoc. 1985 Nov;75(11):575-80. doi: 10.7547/87507315-75-11-575. No abstract available. |
| 9826983 | Background | Gracies JM, Elovic E, McGuire J, Simpson DM. Traditional pharmacological treatments for spasticity. Part I: Local treatments. Muscle Nerve Suppl. 1997;6:S61-91. |
| 1984264 | Background | Gajiwala KJ, Sams SB, Pandya N, Wagh A. A new dynamic lumbrical simulating splint for claw hand deformity. Plast Reconstr Surg. 1991 Jan;87(1):170-3. doi: 10.1097/00006534-199101000-00030. |
| 9826984 | Background | Gracies JM, Nance P, Elovic E, McGuire J, Simpson DM. Traditional pharmacological treatments for spasticity. Part II: General and regional treatments. Muscle Nerve Suppl. 1997;6:S92-120. |
| 12569967 | Background | O'Brien CF. Treatment of spasticity with botulinum toxin. Clin J Pain. 2002 Nov-Dec;18(6 Suppl):S182-90. doi: 10.1097/00002508-200211001-00011. |
| 15201348 | Background | Jankovic J. Botulinum toxin in clinical practice. J Neurol Neurosurg Psychiatry. 2004 Jul;75(7):951-7. doi: 10.1136/jnnp.2003.034702. |
| 2008 | Background | Korelitz BI, Sommers SC. Responses to drug therapy in ulcerative colitis. Evaluation by rectal biopsy and histopathological changes. Am J Gastroenterol. 1975 Nov;64(5):365-70. |
| 18164331 | Background | Stoquart GG, Detrembleur C, Palumbo S, Deltombe T, Lejeune TM. Effect of botulinum toxin injection in the rectus femoris on stiff-knee gait in people with stroke: a prospective observational study. Arch Phys Med Rehabil. 2008 Jan;89(1):56-61. doi: 10.1016/j.apmr.2007.08.131. |
| 16198612 | Background | Lim EC, Ong BK, Seet RC. Botulinum toxin-A injections for spastic toe clawing. Parkinsonism Relat Disord. 2006 Jan;12(1):43-7. doi: 10.1016/j.parkreldis.2005.06.008. Epub 2005 Sep 29. |
| 12362118 | Background | Suputtitada A. Local botulinum toxin type A injections in the treatment of spastic toes. Am J Phys Med Rehabil. 2002 Oct;81(10):770-5. doi: 10.1097/00002060-200210000-00009. |
| 15832139 | Background | Chin TY, Nattrass GR, Selber P, Graham HK. Accuracy of intramuscular injection of botulinum toxin A in juvenile cerebral palsy: a comparison between manual needle placement and placement guided by electrical stimulation. J Pediatr Orthop. 2005 May-Jun;25(3):286-91. doi: 10.1097/01.bpo.0000150819.72608.86. |
| 11889247 | Background | Molloy FM, Shill HA, Kaelin-Lang A, Karp BI. Accuracy of muscle localization without EMG: implications for treatment of limb dystonia. Neurology. 2002 Mar 12;58(5):805-7. doi: 10.1212/wnl.58.5.805. |
| 9826989 | Background | O'Brien CF. Injection techniques for botulinum toxin using electromyography and electrical stimulation. Muscle Nerve Suppl. 1997;6:S176-80. |
| 14738817 | Background | Berweck S, Schroeder AS, Fietzek UM, Heinen F. Sonography-guided injection of botulinum toxin in children with cerebral palsy. Lancet. 2004 Jan 17;363(9404):249-50. doi: 10.1016/S0140-6736(03)15351-2. No abstract available. |
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| 23396653 | Background | Sconfienza LM, Perrone N, Lacelli F, Lentino C, Serafini G. Ultrasound-guided injection of botulinum toxin A in the treatment of iliopsoas spasticity. J Ultrasound. 2008 Sep;11(3):113-7. doi: 10.1016/j.jus.2008.05.002. Epub 2008 Jul 3. |
| 2005922 | Background | Rivest J, Lees AJ, Marsden CD. Writer's cramp: treatment with botulinum toxin injections. Mov Disord. 1991;6(1):55-9. doi: 10.1002/mds.870060110. |
| 12569960 | Background | Critchfield J. Considering the immune response to botulinum toxin. Clin J Pain. 2002 Nov-Dec;18(6 Suppl):S133-41. doi: 10.1097/00002508-200211001-00004. |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D009135 | Muscular Diseases |
| D009140 | Musculoskeletal Diseases |
| D009122 | Muscle Hypertonia |
| D020879 | Neuromuscular Manifestations |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D005530 | Foot Deformities |
| D004798 |
| Enzymes |
| D045762 | Enzymes and Coenzymes |
| D045726 | Metalloproteases |
| D001426 | Bacterial Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D001427 | Bacterial Toxins |
| D014118 | Toxins, Biological |
| D001685 | Biological Factors |
| D005081 | Exercise Therapy |
| D012046 | Rehabilitation |
| D000359 | Aftercare |
| D003266 | Continuity of Patient Care |
| D005791 | Patient Care |
| D013812 | Therapeutics |
| D026741 | Physical Therapy Modalities |
| D015444 | Exercise |
| D009043 | Motor Activity |
| D009068 | Movement |
| D009142 | Musculoskeletal Physiological Phenomena |
| D055687 | Musculoskeletal and Neural Physiological Phenomena |