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

NCT ID: NCT04117282

Last Updated: 2019-10-07

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-02-03
• Study Completion Date: 2019-05-07

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.

Conditions

Cerebral Palsy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

control group

15 children received the regular exercise program including classical gait training for diplegic children (30 minutes exercises + 30 minutes gait training)

Group Type: ACTIVE_COMPARATOR

gait training

Intervention Type: OTHER

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

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)

Group Type: EXPERIMENTAL

gait training

Intervention Type: OTHER

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

Interventions

gait training

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

Intervention Type: OTHER

Other Intervention Names

gait rehabilitation

Eligibility Criteria

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.

• Minimum Eligible Age: 6 Years
• Maximum Eligible Age: 8 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Cairo University

OTHER

Sponsor Role: lead

Responsible Party

Nahla Mohamed Ibrahim

Doctoral degree (lecturer)

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Nahla Mohamed, lecturer

Role: PRINCIPAL_INVESTIGATOR

Cairo University

Locations

Faculty of Physical Therapy,Cairo University

Cairo, Giza Governorate, Egypt

Countries

Egypt

Other Identifiers

pediatric physical therapy

Identifier Type: -

Identifier Source: org_study_id