Gait Rehabilitation in Diplegic Children

Cerebral Palsy Clinical Trial

Official title:

Gait Rehabilitation in Ambulant Diplegic Children Using BOTOX and Ankle Weights

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05294874
• Other study ID #: pediatrics
• Status: Completed
• Phase: N/A
• Start date: July 15, 2021
• Est. completion date: November 25, 2021

Study information

• Verified date: March 2022
• Source: Cairo University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 45
• Est. completion date: November 25, 2021
• Est. primary completion date: November 14, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 5 Years to 10 Years

Eligibility

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.

Related Conditions & MeSH terms

• Cerebral Palsy
• Spastic Diplegia

Intervention

Other:
• gait training
walking forward, sideway and backward walking on balance board

Locations

Country	Name	City	State
Egypt	Faculty of Physical Therapy,Cairo University	Cairo	Giza

Sponsors (1)

Lead Sponsor	Collaborator
Cairo University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.
Primary	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	electromyography to asses spasticity in hamstring and calf muscles	Hoffman/Myogenic reflex to assess spasticity ratio	after 3 months of the treatment program.