Spina BifidaNCT06419049
Impact of Standing Programs in Children With Spina Bifida: A Single Subject Design
A study testing Altimate Medical EasyStand Bantam in people with Spina Bifida, run by University of St. Augustine for Health Sciences at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 5 to 12 years
- Conditions the study is for
- Spina Bifida
- What is being tested?
- Altimate Medical EasyStand Bantam
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteUnited States
- Study dates
- 23 Feb 2023to Aug 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 5 to 12 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 1) 5 to 12 years old, and 2) able to lay in a supine position on a plinth for testing and walk 10 meters. Participants will be excluded from the study if they have medical restrictions that contraindicate moving bilateral lower extremities through full passive range of motion (PROM), including but not limited to joint motion bony blocks, fractures before bone healing is complete, acute inflammatory or infectious process, disruption of soft tissue healing is likely, sharp, acute pain with joint movement or muscle elongation, hematoma or other soft tissue trauma, hypermobility and walking 10 meters.
Who cannot join
- Participants will be excluded from the study if they have: 1) a diagnosis unrelated to MMC form of SB that limits standing, 2) a Modified Hoffer Scale level of 5, indicating an inability to ambulate. 3) medical restrictions that contraindicate standing, including but not limited to fractures and severe osteoporosis that precludes weight-bearing, and compromised cardiovascular or respiratory systems.
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
University of St. Augustine
San Diego, California, 92069
Marianne Hanover, DPT, 760-410-5338
About this study
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:
- Is a home standing program effective in reducing lower extremity passive range of motion limitations in children with Spina Bifida?
- Does a home standing program change the quality of functional movement in children with spina bifida?
- Does a home standing program change a child's performance in daily activities, mobility, and social/cognitive domains?
- Does a home standing program change a child's health-related quality of life in children with spinal bifida?
- Does a home standing program result in a change in gait velocity in children with Spina Bifida?
Read the 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 rater's 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 study's 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.
- Conditions
- Spina Bifida
- Being tested
- Altimate Medical EasyStand Bantam
- Keywords
- Spina Bifida, Standing Device
- Medical subject headings
- Spinal Dysraphism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Altimate Medical EasyStand BantamDevice
Child will stand in stander 5 days per week for 60 min during each 8 wks intervention
| Study group | Role | What they receive |
|---|---|---|
| Standing Program Intervention | Experimental | 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. Receives: Device: Altimate Medical EasyStand Bantam |
| Reliability | No 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Goniometric Measurements
A universal goniometer will be used to measure the child's hip and knee joint passive range of motion.
Measured: Assessed at baseline and every two weeks from the beginning until the conclusion of the study at 28 wks.
10 Meter Walk Test
The 10MWTpref measures gait velocity in youth with neurological diagnoses while using an assistive device and wearing orthoses
Measured: Assessed at baseline and every two weeks from the beginning until the conclusion of the study at 28 wks.
Secondary outcomes (3)
Pediatric Neuromuscular Recovery Scale (Peds NRS)
Assesses the quality of functional movement in children with spina bifida ages 1-12yrs. The Peds NRS examines the quality of sitting, upper extremity function, standing and walking
Measured: Assessed at baseline and every two weeks in the nonintervention phase and every four weeks in intervention phase until the study's conclusion at 28 wks.
Pediatric Evaluation of Disability Computer Adapted Test (PEDI-CAT)
Clinical assessment in children with spinal impairments that measures four domains: 1) Daily Activities, 2) Mobility, 3) Social/Cognitive, and 4) Responsibility to construct a description of a child's functional status in everyday life
Measured: Assessed at baseline and every two weeks in the nonintervention phase and every four weeks in intervention phase until the study's conclusion at 28 wks
Pediatric Quality of Life Inventory (PedsQL™)
Measure of the HRQOL in children with chronic health conditions
Measured: Assessed at baseline and every two weeks in the nonintervention phase and every four weeks in intervention phase until the study's conclusion at 28 wks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 May 2024
- Study start23 Feb 2023
- Primary completionFeb 2025 (estimated)
- Study completionAug 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Spina BifidaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Model description
- Single subject design
- Masking
- None (open label)
- Enrolment
- 12 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of St. Augustine for Health Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06419049
- Sponsor's protocol ID
- 0819-275
- Status last verified
- May 2024
- First submitted
- 13 May 2024
- Last updated
- 17 May 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 17 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Standing Programs in Children With Spina Bifida: A Single Subject Design
- ClinicalTrials.gov ID
- NCT06419049
- Acronym / sponsor ID
- 0819-275
- Conditions
- Spina Bifida
- Keywords
- Spina Bifida, Standing Device
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 12 participants (estimated)
- Lead sponsor
- University of St. Augustine for Health SciencesUniversity, hospital or other
- Study start
- 23 Feb 2023 (actual)
- Primary completion
- Feb 2025 (estimated)
- Study completion
- Aug 2025 (estimated)
- First posted
- 17 May 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- Is a home standing program effective in reducing lower extremity passive range of motion limitations in children with Spina Bifida?
- Does a home standing program change the quality of functional movement in children with spina bifida?
- Does a home standing program change a child's performance in daily activities, mobility, and social/cognitive domains?
- Does a home standing program change a child's health-related quality of life in children with spinal bifida?
- 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 rater's 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 study's 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 design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Single subject design
| Arm | Type | Receives |
|---|---|---|
| Standing Program Intervention | Experimental | Device: Altimate Medical EasyStand BantamA 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. |
| Reliability | No 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. |
Who may qualify
- Ages
- 5 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- 1) 5 to 12 years old, and 2) able to lay in a supine position on a plinth for testing and walk 10 meters. Participants will be excluded from the study if they have medical restrictions that contraindicate moving bilateral lower extremities through full passive range of motion (PROM), including but not limited to joint motion bony blocks, fractures before bone healing is complete, acute inflammatory or infectious process, disruption of soft tissue healing is likely, sharp, acute pain with joint movement or muscle elongation, hematoma or other soft tissue trauma, hypermobility and walking 10 meters.
Key exclusion criteria (1 listed)
- Participants will be excluded from the study if they have: 1) a diagnosis unrelated to MMC form of SB that limits standing, 2) a Modified Hoffer Scale level of 5, indicating an inability to ambulate. 3) medical restrictions that contraindicate standing, including but not limited to fractures and severe osteoporosis that precludes weight-bearing, and compromised cardiovascular or respiratory systems.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Altimate Medical EasyStand BantamChild will stand in stander 5 days per week for 60 min during each 8 wks intervention | Device | Standing Program Intervention |
Primary outcome
Goniometric Measurements
Time frame: Assessed at baseline and every two weeks from the beginning until the conclusion of the study at 28 wks.
A universal goniometer will be used to measure the child's hip and knee joint passive range of motion.
10 Meter Walk Test
Time frame: Assessed at baseline and every two weeks from the beginning until the conclusion of the study at 28 wks.
The 10MWTpref measures gait velocity in youth with neurological diagnoses while using an assistive device and wearing orthoses
3 secondary outcomes
Pediatric Neuromuscular Recovery Scale (Peds NRS)
Time frame: Assessed at baseline and every two weeks in the nonintervention phase and every four weeks in intervention phase until the study's conclusion at 28 wks.
Pediatric Evaluation of Disability Computer Adapted Test (PEDI-CAT)
Time frame: Assessed at baseline and every two weeks in the nonintervention phase and every four weeks in intervention phase until the study's conclusion at 28 wks
Pediatric Quality of Life Inventory (PedsQL™)
Time frame: Assessed at baseline and every two weeks in the nonintervention phase and every four weeks in intervention phase until the study's conclusion at 28 wks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 May 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Altimate Medical EasyStand Bantam in people with Spina Bifida, run by University of St. Augustine for Health Sciences at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 17 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Marianne Hanover, DPT (7604105338, mhanover@usa.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Goniometric Measurements (time frame: Assessed at baseline and every two weeks from the beginning until the conclusion of the study at 28 wks.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 May 2024.