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Gait Rehabilitation in Diplegic Children

Cairo University (CU) logo

Cairo University (CU)

Status

Completed

Conditions

Spastic Diplegia
Cerebral Palsy

Treatments

Other: gait training

Study type

Interventional

Funder types

Other

Identifiers

NCT05294874
pediatrics

Details and patient eligibility

About

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.

Full 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.

Enrollment

45 patients

Sex

All

Ages

5 to 10 years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

45 participants in 3 patient groups

classical gait training
Active Comparator group
Description:
physical therapy exercises including classical gait training
Treatment:
Other: gait training
classical gait training using ankle weight
Active Comparator group
Description:
physical therapy exercises including classical gait training while using ankle weight
Treatment:
Other: gait training
gait training using ankle weight after botulinum toxin injection
Experimental group
Description:
physical therapy exercises including classical gait training while using ankle weight and with BOTOX injection
Treatment:
Other: gait training

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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