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Behavioural Intervention

Standing Program for Spina Bifida

N/A

Recruiting

Research Sponsored by University of St. Augustine for Health Sciences

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Participants must not have medical restrictions that contraindicate moving bilateral lower extremities through full passive range of motion (PROM)

Participants must be 5 to 12 years old

Must not have

Participants with a Modified Hoffer Scale level of 5 indicating an inability to ambulate

Participants with medical restrictions that contraindicate standing, including fractures and severe osteoporosis that precludes weight-bearing, and compromised cardiovascular or respiratory systems

Timeline

Screening 3 weeks

Treatment Varies

Follow Up assessed at baseline and every two weeks from the beginning until the conclusion of the study at 28 wks.

Awards & highlights

No Placebo-Only Group

Summary

"This trial aims to see if a home standing program can help children with spinal bifida who have knee limitations. The study will look at whether this program can reduce limitations in movement, improve functional movement,

Who is the study for?

This trial is for children with Spina Bifida who have significant knee limitations. It aims to see if a home standing program can improve their movement, daily activities, social and cognitive skills, quality of life, and walking speed.

What is being tested?

The study tests the EasyStand Bantam device in a single-subject design to evaluate its impact on children with Spina Bifida. Researchers want to know if using this device at home can help these kids move better and enhance their overall well-being.

What are the potential side effects?

Since this trial involves a non-invasive intervention (a standing device), side effects may include discomfort or fatigue from standing. However, specific side effects will depend on each child's condition and tolerance.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I can move my legs fully without medical restrictions.

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I am between 5 and 12 years old.

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I can lay flat on my back for tests.

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I can walk 10 meters without help.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I cannot walk on my own due to my condition.

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I cannot stand due to medical conditions like severe osteoporosis or heart/lung issues.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ assessed at baseline and every two weeks from the beginning until the conclusion of the study at 28 wks.

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~assessed at baseline and every two weeks from the beginning until the conclusion of the study at 28 wks.

This trial's timeline: 3 weeks for screening, Varies for treatment, and assessed at baseline and every two weeks from the beginning until the conclusion of the study at 28 wks. for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

10 Meter Walk Test

Goniometric Measurements

Secondary study objectives

Pediatric Evaluation of Disability Computer Adapted Test (PEDI-CAT)

Pediatric Neuromuscular Recovery Scale (Peds NRS)

Pediatric Quality of Life Inventory (PedsQL™)

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Standing Program InterventionExperimental Treatment1 Intervention

A single-subject study ABABA design will be used with dependent variables of passive range of motion, functional movement, functional skills performance, engagement, health related quality of life and gait velocity will be recorded repeatedly for the individual participants across time and with systematic manipulation of the independent variable, which is the standing home program intervention. The study will span 28 weeks for the intervention Stage 2, consisting of three baseline phases (A) of four weeks each and two home program intervention phases (B) of eight weeks each that alternate in an ABABA design.

Group II: ReliabilityActive Control1 Intervention

Children will be assessed by two study investigators in two different sessions on the same day, with a washout period of 3 hours between sessions. Intrarater reliability will be determined by comparing rater's scores for each child. These sessions will include goniometric measurements of lower extremity passive range of motion and the 10-Meter Walk Test. Children will have the opportunity to rest or resume normal activities with a minimum of 3 hours between sessions. Interrater reliability will be determined based on the measurements in the same session by 2 different raters.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Altimate Medical EasyStand Bantam

2021

N/A

~10

0 / 6Eligibility criteria met