Gait Rehabilitation in Diplegic Children

Not Applicable

Completed

• Conditions: Spastic Diplegia; Cerebral Palsy

• Registration Number: NCT05294874
• Lead Sponsor: Cairo University

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 Timeline

• Study Start: 2021-07-15
• Primary Completion: 2021-11-14
• Study Completion: 2021-11-25
• Status Verified: 2022-03
• Study First Submitted: 2022-03-06
• Study First Submitted QC: 2022-03-15
• Last Update Submitted: 2022-03-15
• Study First Posted: 2022-03-24
• Last Update Posted: 2022-03-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 45

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
evaluation of spasticity: modified ashowrth scale scores	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	after 3 months of the treatment program.	evaluation of knee flexion range of motion during gait using two dimension gait analysis.

Secondary Outcome Measures

Name	Time	Method
electromyography to asses spasticity in hamstring and calf muscles	after 3 months of the treatment program.	Hoffman/Myogenic reflex to assess spasticity ratio

Trial Locations

Locations (1)

Faculty of Physical Therapy,Cairo University; 🇪🇬 Cairo, Giza, Egypt