NCT05579535

Brief Summary

Background: Children with diplegia had considerably larger hip and knee excursion during gait cycle than did normal developing children. Objective: To investigate the effect of using weight around the ankle on hip excursion in children with diplegia.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Aug 2022

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

Study Start

First participant enrolled

August 3, 2022

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 3, 2022

Completed
4 days until next milestone

Study Completion

Last participant's last visit for all outcomes

October 7, 2022

Completed
3 days until next milestone

First Submitted

Initial submission to the registry

October 10, 2022

Completed
3 days until next milestone

First Posted

Study publicly available on registry

October 13, 2022

Completed
Last Updated

October 13, 2022

Status Verified

October 1, 2022

Enrollment Period

2 months

First QC Date

October 10, 2022

Last Update Submit

October 11, 2022

Conditions

Gait, Spastic

Keywords

Ankle;diplegiagaithip excursionweight

Outcome Measures

Primary Outcomes (1)

  • hip excursion

    hip excursion during gait cycle

    3 months

Study Arms (2)

group A

ACTIVE COMPARATOR

classical gait training

Other: gait training exercises

group B

EXPERIMENTAL

gait training while using weight around ankle

Other: gait training exercises

Interventions

gait training exercisesOTHER

walking exercises in different directions

Also known as: gait rehabilitation
group Agroup B

Eligibility Criteria

Age7 Years - 10 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • able to follow simple basic commands,
  • identified with gait abnormalities described as level II on Gross Motor Function Classification System (GMFCS).
  • diagnosed as spastic diplegia.

You may not qualify if:

  • severe visual or auditory problems,
  • lower limb surgical orthopaedic surgery or
  • BOTOX injection in the six months preceding the start of the study,
  • and uncontrolled seizures.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Nahla

Giza, Egypt

Location

Related Publications (1)

  • Rodda J, Graham HK. Classification of gait patterns in spastic hemiplegia and spastic diplegia: a basis for a management algorithm. Eur J Neurol. 2001 Nov;8 Suppl 5:98-108. doi: 10.1046/j.1468-1331.2001.00042.x.

    PMID: 11851738BACKGROUND

MeSH Terms

Conditions

Gait Disorders, NeurologicBody Weight

Condition Hierarchy (Ancestors)

Neurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Nahla mohamed, phd

    Cairo University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
lecturer at pediatric department faculty of physical therapy

Study Record Dates

First Submitted

October 10, 2022

First Posted

October 13, 2022

Study Start

August 3, 2022

Primary Completion

October 3, 2022

Study Completion

October 7, 2022

Last Updated

October 13, 2022

Record last verified: 2022-10

Data Sharing

IPD Sharing
Will share

available when contact the corresponding author including protocol

Shared Documents
STUDY PROTOCOL
Time Frame
after published online
Access Criteria
authors

Locations

EG(1)