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Completed

NCT Number: NCT05294874

Gait Rehabilitation in Diplegic Children

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.

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Key information

Conditions

Cerebral Palsy Brain Damage, Chronic Brain Diseases Central Nervous System Diseases Nervous System Diseases Spastic Diplegia

Age range

5 year–10 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Faculty of Physical Therapy,Cairo University

Cairo, Giza Governorate, 02, Egypt

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Gait Training

Other

walking forward, sideway and backward walking on balance board

Other names: rehabilitation

Primary outcomes

  1. measurement of knee excursion during gait

    Time frame: after 3 months of the treatment program.

    evaluation of knee flexion range of motion during gait using two dimension gait analysis.

  2. evaluation of spasticity: modified ashowrth scale scores

    Time frame: 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)

Secondary outcomes

  1. electromyography to asses spasticity in hamstring and calf muscles

    Time frame: after 3 months of the treatment program.

    Hoffman/Myogenic reflex to assess spasticity ratio

Sponsors and collaborators

Lead sponsor

Cairo University

Other

Registry information

Official study title

Gait Rehabilitation in Ambulant Diplegic Children Using BOTOX and Ankle Weights

Important dates

Study start
2021
Primary completion
2021
Study completion
2021
First posted
Mar 24, 2022
Registry last updated
Mar 24, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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