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

Not Applicable

Completed

• Conditions: Cerebral Palsy
• Interventions: Other: gait training

• Registration Number: NCT04117282
• Lead Sponsor: Cairo University

Brief Summary

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 .

Detailed Description

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.

Study Timeline

• Study Start: 2019-02-03
• Primary Completion: 2019-05-05
• Study Completion: 2019-05-07
• Status Verified: 2019-10
• Study First Submitted: 2019-10-02
• Study First Submitted QC: 2019-10-03
• Last Update Submitted: 2019-10-03
• Study First Posted: 2019-10-07
• Last Update Posted: 2019-10-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
control group	gait training	15 children received the regular exercise program including classical gait training for diplegic children (30 minutes exercises + 30 minutes gait training)
study group	gait training	15 diplegic child received the same exercise program including the use of the antigravity shoes for gait training (30 minutes exercises + 30 minutes gait training)

Primary Outcome Measures

Name	Time	Method
gait time percentage of left lower limb	after 3 months of treatment	the time of stance and swing phases as a percentage for left lower limb during gait
gait time percentage for right lower limb	after 3 months of treatment	the time of stance and swing phases as a percentage for right lower limb during gait

Secondary Outcome Measures

Name	Time	Method
level of function through GMFCS	before and after 3 months of treatment	changing the level of function by using the GMFCS

Trial Locations

Locations (1)

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