NCT05420363

Brief Summary

Using challenging surfaces of gait training, which require constant adjustments of the body's movement patterns to maintain stability and provide different sensory and proprioceptive inputs to mimic real life situation is appropriate for children with CP. So, the purpose of the current study is to investigate the influence of surface characteristics of gait training on gait kinematics and walking capacity in children with diplegic CP.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jul 2022

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 10, 2022

Completed
5 days until next milestone

First Posted

Study publicly available on registry

June 15, 2022

Completed
16 days until next milestone

Study Start

First participant enrolled

July 1, 2022

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2022

Completed
Last Updated

June 15, 2022

Status Verified

June 1, 2022

Enrollment Period

2 months

First QC Date

June 10, 2022

Last Update Submit

June 14, 2022

Conditions

Keywords

CP , Diplegia

Outcome Measures

Primary Outcomes (4)

  • kinematics gait parameters

    step length

    over 3 months

  • kinematics gait parameters

    step width

    over 3 months

  • kinematics gait parameters

    double support time

    over 3 months

  • kinematics gait parameters

    cadence

    over 3 months

Secondary Outcomes (1)

  • Six-minute walking test

    over 3 months

Study Arms (2)

traditional physical therapy + gait training on different surfaces.

EXPERIMENTAL

Children in study group will receive designed physical therapy program in addition to gait training on different surfaces.

Other: different walking surfaces

traditional physical therapy + traditional gait training

EXPERIMENTAL

-Children in control group will receive designed physical therapy program in addition to traditional gait training hard surface .

Other: traditional gait training over hard surface only

Interventions

different surfaces materials and textures as sand ,grass, air mattress , foam mattress ,gravels and Rollator

traditional physical therapy + gait training on different surfaces.

The children will receive gait training over hard surface and even ground only and bare feet without wearing any foot ware or orthosis

traditional physical therapy + traditional gait training

Eligibility Criteria

Age6 Years - 8 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Their ages will range from 6 to 8 years old.
  • The degree of spasticity will range from grade 1 or 1+ according to Modified Ashworth Scale.
  • They will be at level II on GMFCS .
  • They will be able to follow verbal command or instructions.

You may not qualify if:

  • \. Fixed deformities of lower limbs. 2. Sever visual or auditory problems. 3. History of surgical interference in lower limbs less than one year. 4. Botulinum toxin injections to the lower limb during the previous 4 months.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cairo university , Faculty of Physical Therapy

Cairo, Egypt

RECRUITING

MeSH Terms

Conditions

Cerebral Palsy

Condition Hierarchy (Ancestors)

Brain Damage, ChronicBrain DiseasesCentral Nervous System DiseasesNervous System Diseases

Central Study Contacts

Shimaa A. Mohamed, B.Sc.

CONTACT

walaa A. Abd El-Nabie, Ass. Prof.

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
FACTORIAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
principle investigator

Study Record Dates

First Submitted

June 10, 2022

First Posted

June 15, 2022

Study Start

July 1, 2022

Primary Completion

September 1, 2022

Study Completion

September 1, 2022

Last Updated

June 15, 2022

Record last verified: 2022-06

Data Sharing

IPD Sharing
Will not share

Locations