Gait Rehabilitation in Ambulant Diplegic Children Using BOTOX and Ankle Weights
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Cairo University
- Enrollment
- 45
- Locations
- 1
- Primary Endpoint
- evaluation of spasticity: modified ashowrth scale scores
Study Overview
Brief Summary
Background: Standing and walking serve an individual's basic need to move from place to place, and both are the most common activities that people do on a daily basis.
Aim: to investigate the combined effect of botulinum toxin A (BoNT-A) injection and ankle weight on the gait of diplegic children who are using Ankle foot orthoses.
Detailed Description
Methods: Sixty children with spastic diplegia were included in this prospective, controlled trial. Children were divided into three groups, each with 20 patients: Group 1 received classical gait rehabilitation; Group 2 received the same gait training while adding ankle weight ; and Group 3 received the same as group 2 plus botulinum toxin injection. The Modified Ashworth Scale (MAS),knee range-of-motion measures, and Hoffman /Myogenic reflex ratio were used to examine patients before the commencement of treatment and post-treatment.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 5 Years to 10 Years (Child)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •diagnosed as spastic diplegia.
- •They were able to follow simple verbal instructions.
- •The use of Ankle Foot Orthoses.
- •Spasticity grade of 1+ or 2 in both calf and hamstring muscles according to modified Ashworth's scale (MAS).
- •level I or II on the Gross Motor Function Classification System (GMFCS).
Exclusion Criteria
- •fixed contractures or deformities in the lower limbs.
- •surgical orthopedic intervention.
- •Botulinum A injection or use of neuromuscular blockers in the previous 6 months before the start of study.
Arms & Interventions
classical gait training
physical therapy exercises including classical gait training
Intervention: gait training (Other)
classical gait training using ankle weight
physical therapy exercises including classical gait training while using ankle weight
Intervention: gait training (Other)
gait training using ankle weight after botulinum toxin injection
physical therapy exercises including classical gait training while using ankle weight and with BOTOX injection
Intervention: gait training (Other)
Outcomes
Primary Outcomes
evaluation of spasticity: modified ashowrth scale scores
Time Frame: after 3 months of the treatment program.
hamstring and calf muscles evaluation of spasticity through passive movement .the score ranged from 0 ( nearly normal) to 5 (rigid in flexion or extension)
measurement of knee excursion during gait
Time Frame: after 3 months of the treatment program.
evaluation of knee flexion range of motion during gait using two dimension gait analysis.
Secondary Outcomes
- electromyography to asses spasticity in hamstring and calf muscles(after 3 months of the treatment program.)
Investigators
Nahla Mohamed Ibrahim
lecturer physical therapy
Cairo University