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

Cerebral Palsy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04117282
• Other study ID #: pediatric physical therapy
• Status: Completed
• Phase: N/A
• Start date: February 3, 2019
• Est. completion date: May 7, 2019

Study information

• Verified date: October 2019
• Source: Cairo University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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 .

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: May 7, 2019
• Est. primary completion date: May 5, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 6 Years to 8 Years

Eligibility

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.

Related Conditions & MeSH terms

• Cerebral Palsy

Intervention

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

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	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
Primary	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	level of function through GMFCS	changing the level of function by using the GMFCS	before and after 3 months of treatment