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NCT Number: NCT04117282

Effect of Antigravity Shoes on Improving the Quality of Gait in Children With Spastic Diplegia

Improving the quality of gait in the diplegic children is a major concern in the rehabilitation program. Thirty children with spastic diplegia were distributed equally into 2 groups, group A (control) and group B (study). Group A had received the traditional physical therapy program for 30 minutes and 30 minutes traditional gait training, while group B had received 30 minutes gait training with antigravity shoes in addition to the traditional exercise program for 30 minutes, percentage of stance and swing phase of gait were measured by 2 D gait analysis for children of both groups pre and after 3 successive months of treatment program, also function level of gait were assessed pre and post treatment by GMFCS .

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Key information

Conditions

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

Age range

6 year–8 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

Thirty children with spastic diplegia, their age ranged from 6 to 8 years old, were distributed equally into 2 groups: group A (control) and group B (study) They could walk with limitation or holding on according to GMFCS (level II &III). (Palisano et al., 2008). Increased time for stance phase and decreased swing phase time was recorded when evaluated by 2D gait analysis.

Control group (A):

The children in this group had received traditional physical therapy exercise program designed for those cases for 30 minutes in addition to gait training program for 30 minutes / day, 3 times / week for 3 successive months.

Study group (B):

The children in this group received the same traditional exercise program for 30 minutes in addition to gait training program for 30 minutes using the antigravity shoes.

evaluation was done before and after treatment. treatment include traditional exercises for gait and balance for both groups in addition to use the antigravity shoes for study group.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • 30 diplegic children of both gender aged from 6 to 8,
  • GMFCS levelII and II . has gait defecits including percentage of gait cycles.

Exclusion criteria

  • recent surgical intervention.
  • orthopedic deformity in lower limbs.
  • sever vision or hearing problems.

Treatment and study plan

Gait Training

Other

training for improving the quality of gait through adjusting gait cycle phases time and improving the functional level and independence during gait

Other names: gait rehabilitation

Primary outcomes

  1. gait time percentage for right lower limb

    Time frame: after 3 months of treatment

    the time of stance and swing phases as a percentage for right lower limb during gait

  2. gait time percentage of left lower limb

    Time frame: after 3 months of treatment

    the time of stance and swing phases as a percentage for left lower limb during gait

Secondary outcomes

  1. level of function through GMFCS

    Time frame: before and after 3 months of treatment

    changing the level of function by using the GMFCS

Sponsors and collaborators

Lead sponsor

Cairo University

Other

Registry information

Official study title

Effect of Antigravity Shoes on Improving the Quality of Gait in Children With Spastic Diplegia (Using 2 D Gait Analysis)

Important dates

Study start
2019
Primary completion
2019
Study completion
2019
First posted
Oct 7, 2019
Registry last updated
Oct 7, 2019

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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