Effect of Spring Gravity Bar on Gait Pattern in Children With Spastic Diplegia

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

Study Overview

• Status: Unknown
• Conditions: Spastic Diplegia Cerebral Palsy
• Intervention / Treatment: Device: Spring gravity bar

Detailed Description

The purpose of this study is to provide insight on investigate the effectiveness of vestibular stimulation on gait pattern by using spring gravity bar , when you bounce up and down it stimulate vestibular system that is considered straight line vestibular stimulation and strength extensor muscle of lower limb by pressure on spring during stance phase all that change gait stability and stride length so can improve gait pattern .

• Study Type: Interventional
• Enrollment (Anticipated): 20
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Baseem Zaki Mahmoud, BSc physiotherapy; Phone Number: 002001553896691; Email: baseem2022@googlemail.com
• Study Contact Backup: Name: Nahla Mohamed Ibrahium, Lecture; Phone Number: 002001001937744; Email: Nahlahegazy1983@googlemail.com

Study Locations

• Egypt
  • Cairo, Egypt
    • Recruiting
    • Cairo University Pediatric Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 7 years to 10 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

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

Exclusion Criteria:

- 1-children with any visual or auditory abnormalities. 2-children receiving any special medication affecting muscle and /or mental function.

3-children had any recent surgical interference in the lower limb. 4-children with perceptual defects. 5-children with fixed structural deformities lower limb.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Study group; 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; contain two wooden board length (160 cm) and width (15 cm); contain pair of spring at every end of board; two wooden board connect in the middle

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Cairo University

Study record dates

Study Major Dates

• Study Start (Actual): September 21, 2020
• Primary Completion (Anticipated): November 1, 2020
• Study Completion (Anticipated): December 1, 2020

Study Registration Dates

• First Submitted: November 7, 2020
• First Submitted That Met QC Criteria: November 7, 2020
• First Posted (Actual): November 13, 2020

Study Record Updates

• Last Update Posted (Actual): November 13, 2020
• Last Update Submitted That Met QC Criteria: November 7, 2020
• Last Verified: November 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurologic Manifestations; Brain Damage, Chronic; Musculoskeletal Diseases; Muscular Diseases; Neuromuscular Manifestations; Muscle Hypertonia; Cerebral Palsy; Muscle Spasticity
• Other Study ID Numbers: P.T.REC/012/002557

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No