Ignite Creation Date:
2024-05-19 @ 5:35 PM
Last Modification Date:
2024-10-26 @ 3:30 PM
Study NCT ID:
NCT06419049
Status:
RECRUITING
Last Update Posted:
2024-05-17
First Post:
2024-05-13
Brief Title:
Impact of Standing Programs in Children With Spina Bifida A Single Subject Design
Sponsor:
University of St Augustine for Health Sciences
Organization:
University of St Augustine for Health Sciences
Study Overview
Official Title:
Impact of Standing Programs in Children With Spina Bifida A Single Subject Design
Status:
RECRUITING
Status Verified Date:
2024-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of this single-subject study is to investigate children with spinal bifida who have significant knee limitations in lower extremity passive range of motion to answer the following research questions
1 Is a home standing program effective in reducing lower extremity passive range of motion limitations in children with Spina Bifida
2 Does a home standing program change the quality of functional movement in children with spina bifida
3 Does a home standing program change a childs performance in daily activities mobility and socialcognitive domains
4 Does a home standing program change a childs health-related quality of life in children with spinal bifida
5 Does a home standing program result in a change in gait velocity in children with Spina Bifida
1 Is a home standing program effective in reducing lower extremity passive range of motion limitations in children with Spina Bifida
2 Does a home standing program change the quality of functional movement in children with spina bifida
3 Does a home standing program change a childs performance in daily activities mobility and socialcognitive domains
4 Does a home standing program change a childs health-related quality of life in children with spinal bifida
5 Does a home standing program result in a change in gait velocity in children with Spina Bifida
Detailed Description:
Stage 1 Reliability Stage Each child 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 raters scores for each child These sessions will include goniometric measurements of lower extremity PROM 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
Stage 2 Intervention Stage 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
Regardless of the phase the following primary measures will be assessed at baseline and every two weeks from the beginning until the conclusion of the study Goniometric passive range of motion for all phases and hip and knee angle measures while standing in the stander during intervention phases and 10 meter walk test at preferred walking speed
The following secondary measures will be assessed at baseline and every two weeks in phase A and every four weeks in phase B until the studys conclusion Pediatric Neuromuscular Recovery Scale Pediatric Evaluation of Disability Computer Adapted Test and Pediatric Quality of Life Inventory
Nonintervention phase A The study investigator will meet face to face with the participant biweekly for 28 weeks to perform primary and secondary outcome measures The Pediatric Neuromuscular Recovery Scale will be administered by the study investigator in person and scored by another investigator who is an expert with the Pediatric Neuromuscular Recovery Scale via video conference not recorded
Intervention phase B The study investigator will meet face to face with the participant biweekly for 28 weeks to perform outcome measures The Pediatric Neuromuscular Recovery Scale will be administered by the study investigator in person and scored by another investigator via video conference During the B phase the study investigator will also provide parent instruction on the standing home program to ensure the parent and child can follow the home program EasyStand will be providing the participants with the sit to stand stander for the duration of the intervention phases A photo of the child in the stander will be taken by the investigator during each of these sessions and may be used in the dissemination of the project The parent will keep a daily log of stander use and usual physical therapy-related activities All of the measures will be analyzed to determine if there is a functional effect and if so quantitative analysis methods will be used to determine the magnitude of the effect and then the effect sizes will be combined to average intervention effects
Stage 2 Intervention Stage 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
Regardless of the phase the following primary measures will be assessed at baseline and every two weeks from the beginning until the conclusion of the study Goniometric passive range of motion for all phases and hip and knee angle measures while standing in the stander during intervention phases and 10 meter walk test at preferred walking speed
The following secondary measures will be assessed at baseline and every two weeks in phase A and every four weeks in phase B until the studys conclusion Pediatric Neuromuscular Recovery Scale Pediatric Evaluation of Disability Computer Adapted Test and Pediatric Quality of Life Inventory
Nonintervention phase A The study investigator will meet face to face with the participant biweekly for 28 weeks to perform primary and secondary outcome measures The Pediatric Neuromuscular Recovery Scale will be administered by the study investigator in person and scored by another investigator who is an expert with the Pediatric Neuromuscular Recovery Scale via video conference not recorded
Intervention phase B The study investigator will meet face to face with the participant biweekly for 28 weeks to perform outcome measures The Pediatric Neuromuscular Recovery Scale will be administered by the study investigator in person and scored by another investigator via video conference During the B phase the study investigator will also provide parent instruction on the standing home program to ensure the parent and child can follow the home program EasyStand will be providing the participants with the sit to stand stander for the duration of the intervention phases A photo of the child in the stander will be taken by the investigator during each of these sessions and may be used in the dissemination of the project The parent will keep a daily log of stander use and usual physical therapy-related activities All of the measures will be analyzed to determine if there is a functional effect and if so quantitative analysis methods will be used to determine the magnitude of the effect and then the effect sizes will be combined to average intervention effects
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None