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

NCT02586142 | Completed Phase 3

• 1 other identifier: NMRPG890041
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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:

1. 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. 2.assess if regular stretching exercise can strength the efficiency of BTX-A injection on improving lower extremities function, pain and spasticity.

Conditions

Cerebrovascular Accident

Keywords

spasticity; claw toe; ultrasounds guidance; botulinum toxin; stretching exercise

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (14)

• Sensory function scale

  Change from Baseline data at 1 year

• Brunnstrome stage

  Change from Baseline data at 1 year

• Manual muscle test

  Change from Baseline data at 1 year

• Functional ambulation classification scale

  Change from Baseline data at 1 year

• Active range of motion measured by goniometer

  Change from Baseline data at 1 year

Study Arms (2)

Botulinum toxin type A(BTX-A) injection

EXPERIMENTAL

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

Drug: Botulinum Toxin Type A

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.

Drug: Botulinum Toxin Type A; Other: Stretching exercise

Interventions

Botulinum Toxin Type A DRUG

To inject Botulinum toxin type A on the spasticity lower extremity for stroke patients by ultrasounds guidance.

Also known as: Botulinum toxin

BTX-A injection plus stretching exercise; Botulinum toxin type A(BTX-A) injection

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.

BTX-A injection plus stretching exercise

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Chang Gung Memorial Hospital: lead

Study Sites (1)

Chang Gung Memorial Hospital

Kaohsiung City, Taiwan

Location

Related Publications (26)

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MeSH Terms

Conditions

Stroke; Muscle Spasticity; Hammer Toe Syndrome

Interventions

Botulinum Toxins, Type A; Botulinum Toxins; Muscle Stretching Exercises

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Muscular Diseases; Musculoskeletal Diseases; Muscle Hypertonia; Neuromuscular Manifestations; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Foot Deformities

Intervention Hierarchy (Ancestors)

Metalloendopeptidases; Endopeptidases; Peptide Hydrolases; Hydrolases; Enzymes; Enzymes and Coenzymes; Metalloproteases; Bacterial Proteins; Proteins; Amino Acids, Peptides, and Proteins; Bacterial Toxins; Toxins, Biological; Biological Factors; Exercise Therapy; Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Therapeutics; Physical Therapy Modalities; Exercise; Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Pong Ya-Ping, MD

  Rehabilitation

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 12, 2015
• First Posted: October 26, 2015
• Study Start: August 1, 2010
• Primary Completion: July 1, 2013
• Study Completion: July 1, 2013
• Last Updated: October 26, 2015

Record last verified: 2010-08

Locations

TW (1)