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

NCT04117282 | Completed

• 1 other identifier: pediatric physical therapy
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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 .

Conditions

Cerebral Palsy

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (1)

• level of function through GMFCS

  before and after 3 months of treatment

Study Arms (2)

control group

ACTIVE COMPARATOR

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

Other: gait training

study group

EXPERIMENTAL

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

Interventions

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

Also known as: gait rehabilitation

control group; study group

Eligibility Criteria

• Age: 6 Years - 8 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

Faculty of Physical Therapy,Cairo University

Cairo, Giza Governorate, 02, Egypt

Location

MeSH Terms

Conditions

Cerebral Palsy

Condition Hierarchy (Ancestors)

Brain Damage, Chronic; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Study Officials

• Nahla Mohamed, lecturer

  Cairo University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Doctoral degree (lecturer)

Model Details: 2 groups study and control

Study Record Dates

• First Submitted: October 2, 2019
• First Posted: October 7, 2019
• Study Start: February 3, 2019
• Primary Completion: May 5, 2019
• Study Completion: May 7, 2019
• Last Updated: October 7, 2019

Record last verified: 2019-10

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)