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Gait Rehabilitation in Diplegic Children

Gait Rehabilitation in Ambulant Diplegic Children Using BOTOX and Ankle Weights

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05294874
Enrollment
45
Registered
2022-03-24
Start date
2021-07-15
Completion date
2021-11-25
Last updated
2022-03-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cerebral Palsy, Spastic Diplegia

Keywords

gait, diplegia, ankle weight, botox injection

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.

Interventions

OTHERgait training

walking forward, sideway and backward walking on balance board

Sponsors

Cairo University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
5 Years to 10 Years
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.

Design outcomes

Primary

MeasureTime frameDescription
measurement of knee excursion during gaitafter 3 months of the treatment program.evaluation of knee flexion range of motion during gait using two dimension gait analysis.
evaluation of spasticity: modified ashowrth scale scoresafter 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)

Secondary

MeasureTime frameDescription
electromyography to asses spasticity in hamstring and calf musclesafter 3 months of the treatment program.Hoffman/Myogenic reflex to assess spasticity ratio

Countries

Egypt

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026