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

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

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 .

Study Overview

• Status: Completed
• Conditions: Cerebral Palsy
• Intervention / Treatment: Other: gait training

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 Type: Interventional
• Enrollment (Actual): 30
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Giza
    • Cairo, Giza, Egypt, 02
      • Faculty of physical therapy,Cairo university

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 6 years to 8 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: control group; 15 children received the regular exercise program including classical gait training for diplegic children (30 minutes exercises + 30 minutes gait training)	Other: gait training; 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
Experimental: study group; 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)	Other: gait training; 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
gait time percentage for right lower limb	the time of stance and swing phases as a percentage for right lower limb during gait	after 3 months of treatment
gait time percentage of left lower limb	the time of stance and swing phases as a percentage for left lower limb during gait	after 3 months of treatment

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
level of function through GMFCS	changing the level of function by using the GMFCS	before and after 3 months of treatment

Collaborators and Investigators

• Sponsor: Cairo University
• Investigators: Principal Investigator: Nahla Mohamed, lecturer, Cairo University

Study record dates

Study Major Dates

• Study Start (Actual): February 3, 2019
• Primary Completion (Actual): May 5, 2019
• Study Completion (Actual): May 7, 2019

Study Registration Dates

• First Submitted: October 2, 2019
• First Submitted That Met QC Criteria: October 3, 2019
• First Posted (Actual): October 7, 2019

Study Record Updates

• Last Update Posted (Actual): October 7, 2019
• Last Update Submitted That Met QC Criteria: October 3, 2019
• Last Verified: October 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Brain Damage, Chronic; Cerebral Palsy
• Other Study ID Numbers: pediatric physical therapy

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No