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

Primary Purpose

Cerebral Palsy

Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
gait training
Sponsored by
Cairo University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cerebral Palsy

Eligibility Criteria

6 Years - 8 Years (Child)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Faculty of Physical Therapy,Cairo University

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

control group

study group

Arm Description

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

Outcomes

Primary Outcome Measures

gait time percentage for right lower limb
the time of stance and swing phases as a percentage for right lower limb during gait
gait time percentage of left lower limb
the time of stance and swing phases as a percentage for left lower limb during gait

Secondary Outcome Measures

level of function through GMFCS
changing the level of function by using the GMFCS

Full Information

First Posted
October 2, 2019
Last Updated
October 3, 2019
Sponsor
Cairo University
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1. Study Identification

Unique Protocol Identification Number
NCT04117282
Brief Title
Effect of Antigravity Shoes on Improving the Quality of Gait in Children With Spastic Diplegia
Official Title
Effect of Antigravity Shoes on Improving the Quality of Gait in Children With Spastic Diplegia (Using 2 D Gait Analysis)
Study Type
Interventional

2. Study Status

Record Verification Date
October 2019
Overall Recruitment Status
Completed
Study Start Date
February 3, 2019 (Actual)
Primary Completion Date
May 5, 2019 (Actual)
Study Completion Date
May 7, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Cairo University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cerebral Palsy

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
2 groups study and control
Masking
None (Open Label)
Allocation
Randomized
Enrollment
30 (Actual)

8. Arms, Groups, and Interventions

Arm Title
control group
Arm Type
Active Comparator
Arm Description
15 children received the regular exercise program including classical gait training for diplegic children (30 minutes exercises + 30 minutes gait training)
Arm Title
study group
Arm Type
Experimental
Arm Description
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)
Intervention Type
Other
Intervention Name(s)
gait training
Other Intervention Name(s)
gait rehabilitation
Intervention Description
training for improving the quality of gait through adjusting gait cycle phases time and improving the functional level and independence during gait
Primary Outcome Measure Information:
Title
gait time percentage for right lower limb
Description
the time of stance and swing phases as a percentage for right lower limb during gait
Time Frame
after 3 months of treatment
Title
gait time percentage of left lower limb
Description
the time of stance and swing phases as a percentage for left lower limb during gait
Time Frame
after 3 months of treatment
Secondary Outcome Measure Information:
Title
level of function through GMFCS
Description
changing the level of function by using the GMFCS
Time Frame
before and after 3 months of treatment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
6 Years
Maximum Age & Unit of Time
8 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nahla Mohamed, lecturer
Organizational Affiliation
Cairo University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Faculty of Physical Therapy,Cairo University
City
Cairo
State/Province
Giza
ZIP/Postal Code
02
Country
Egypt

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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