Clinical trial NCT04117282: 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
Overall status: COMPLETED
Phase: NA
Conditions: Cerebral Palsy
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2019-10-07
Enrollment: 30
Sex: ALL
Minimum age (years): 6
Maximum age (years): 8
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 2 groups study and control
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: gait time percentage for right lower limb
timeFrame: after 3 months of treatment
measure: gait time percentage of left lower limb
timeFrame: after 3 months of treatment
Secondary outcomes:
measure: level of function through GMFCS
timeFrame: before and after 3 months of treatment
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Faculty of Physical Therapy,Cairo University
state: Giza
Study officials:
affiliation: Cairo University
name: Nahla Mohamed, lecturer
role: PRINCIPAL_INVESTIGATOR
References: