Gait Rehabilitation in Diplegic Children

Study Overview
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Brief Summary
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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
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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.

Official Title
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Gait Rehabilitation in Ambulant Diplegic Children Using BOTOX and Ankle Weights

Conditions
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Cerebral Palsy, Spastic Diplegia

Intervention / Treatment
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* Other: gait training


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 5 Years
Maximum Age: 10 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: classical gait training<br>physical therapy exercises including classical gait training | Other: gait training<br>* walking forward, sideway and backward walking on balance board<br>* Other names: rehabilitation;|
| Active Comparator: classical gait training using ankle weight<br>physical therapy exercises including classical gait training while using ankle weight | Other: gait training<br>* walking forward, sideway and backward walking on balance board<br>* Other names: rehabilitation;|
| Experimental: gait training using ankle weight after botulinum toxin injection<br>physical therapy exercises including classical gait training while using ankle weight and with BOTOX injection | Other: gait training<br>* walking forward, sideway and backward walking on balance board<br>* Other names: rehabilitation;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| measurement of knee excursion during gait | evaluation of knee flexion range of motion during gait using two dimension gait analysis. | after 3 months of the treatment program. | 
| evaluation of spasticity: modified ashowrth scale scores | hamstring and calf muscles evaluation of spasticity through passive movement .the score ranged from 0 ( nearly normal) to 5 (rigid in flexion or extension) | after 3 months of the treatment program. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| electromyography to asses spasticity in hamstring and calf muscles | Hoffman/Myogenic reflex to assess spasticity ratio | after 3 months of the treatment program. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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gait, diplegia, ankle weight, botox injection