NCT04628247

Brief Summary

The purpose of the study is to determine the effect of spring gravity bar on gait pattern in children with spastic diplegia

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
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Sep 2020

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

Study Start

First participant enrolled

September 21, 2020

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2020

Completed
6 days until next milestone

First Submitted

Initial submission to the registry

November 7, 2020

Completed
6 days until next milestone

First Posted

Study publicly available on registry

November 13, 2020

Completed
18 days until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2020

Completed
Last Updated

November 13, 2020

Status Verified

November 1, 2020

Enrollment Period

1 month

First QC Date

November 7, 2020

Last Update Submit

November 7, 2020

Conditions

Outcome Measures

Primary Outcomes (2)

  • Two dimensional gait analysis

    Two-dimensional (2D) video analysis may provide an accessible and affordable means of quantifying postural control deficits that can be implemented across a spectrum of care settings. Angular joint measures during weight lifting obtained using 2D motion analysis software have been shown to be highly correlated to goniometric measures . This system has also been shown to be reliable in quantifying range of motion during reaching and walking/running tasks

    20 minute

  • Dynamic gait index

    The Dynamic Gait Index is a sensitive and efficient tool for adults and therefore may be a useful tool for children. Dynamic Gait Index (DGI) is a performance-based tool that quantifiesthe dynamic balance instability developed by Shumway-Cook and Woollacott, evaluates the ability of the individual to modify gait in response to changing functions during walking

    20 minute

Study Arms (1)

Study group

EXPERIMENTAL

They will receive the same traditional physical therapy exercise program in addition to gait training on spring gravity bar for one hour

Device: Spring gravity bar

Interventions

1. contain two wooden board length (160 cm) and width (15 cm) 2. contain pair of spring at every end of board 3. two wooden board connect in the middle

Study group

Eligibility Criteria

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

You may qualify if:

  • Their age will be extended from 7 to 10 years.
  • They can walk with limitation or holding on according to GMFCS (level II \& II).
  • They can understand and follow instruction.

You may not qualify if:

  • \- 1-children with any visual or auditory abnormalities. 2-children receiving any special medication affecting muscle and /or mental function.
  • children had any recent surgical interference in the lower limb. 4-children with perceptual defects. 5-children with fixed structural deformities lower limb.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cairo University Pediatric Hospital

Cairo, Egypt

RECRUITING

MeSH Terms

Conditions

Cerebral palsy, spastic, diplegic

Central Study Contacts

Baseem Zaki Mahmoud, BSc physiotherapy

CONTACT

Nahla Mohamed Ibrahium, Lecture

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
BSc physiotherapy

Study Record Dates

First Submitted

November 7, 2020

First Posted

November 13, 2020

Study Start

September 21, 2020

Primary Completion

November 1, 2020

Study Completion

December 1, 2020

Last Updated

November 13, 2020

Record last verified: 2020-11

Locations