Spina Bifida With HydrocephalusNCT05251740
Impact of a Standing Program in a Child With Spina Bifida: A Case Report
A study testing Altimate Medical EasyStand Bantam in people with Spina Bifida With Hydrocephalus, run by University of St. Augustine for Health Sciences at 1 site in United States.
Trial summary
The purpose of this case study is to investigate a child with MMC who has significant knee and hip flexion contractures to answer the following research questions: 1) Is a home standing program effective in reducing hip and knee flexion contractures in a child with MMC? 2) Does a home standing program result in a… Read more about this study
- Who is it for?
- Ages 9 to 9 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Spina Bifida With Hydrocephalus
- 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
- 1 participants
- Where
- 1 siteUnited States
- Study dates
- 6 May 2021to 8 Jul 2021
- 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 9 to 9 years
- Women only
- Healthy volunteers accepted
- Child
Who may be able to join
- diagnosis of Spina Bifida
- be able to stand with an assistive device
Who cannot join
- a diagnosis unrelated to Spina Bifida that limits standing
- medical restrictions that contraindicate standing
Trial locations and contacts
1 site in 1 country.
United States1 site
University of St. Augustine
San Marcos, California, 92069
About this study
The purpose of this case study is to investigate a child with MMC who has significant knee and hip flexion contractures to answer the following research questions: 1) Is a home standing program effective in reducing hip and knee flexion contractures in a child with MMC? 2) Does a home standing program result in a change in the quality of functional movement?
A Physical therapist, PT, will administer the Peds NRS and goniometric measurements prior to the start of the study and at the end of the study. The PT will also provide the parent instruction on the standing home program with weekly check-ins to ensure the parent and child are able to follow the home program. The home standing program will last 8 weeks. The parent will keep a written log of stander use. The Peds NRS scores and goniometric measurements will be compared pre and post intervention. The expected outcome is that the Peds NRS scores and hip and knee extension range of motion measurements will improve.
- Conditions
- Spina Bifida With Hydrocephalus
- Being tested
- Altimate Medical EasyStand Bantam
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Altimate Medical EasyStand BantamDevice
The child will stand in the device for 60 min per day, 5 days per week for 2 months.
| Study group | Role | What they receive |
|---|---|---|
| Standing program | Experimental | The child completes a 60-minute home standing program five days per week over eight weeks. Receives: Device: Altimate Medical EasyStand Bantam |
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 ranges of motion (PROM).
Measured: At 0 weeks
Goniometric measurements
A universal goniometer will be used to measure the child's hip and knee joint passive ranges of motion (PROM).
Measured: At 8 weeks
Pediatric Neuromuscular Recovery Scale (Peds NRS)
The Pediatric Neuromuscular Recovery Scale (Peds NRS) assesses the quality of functional movement in children with MMC ages 1-12years. The Peds NRS examines the quality of sitting, upper extremity function, standing, and walking.The examiner administers the Peds NRS using a height-adjustable bench, mat table, fine motor manipulatives, and a ball. The examiner scores each of the 13 items on the Peds NRS on a 12-point scale, with one point allocated to each of the 12 phases of the item. The examiner scores the highest phase achieved by the child. A summary score is obtained using the sum of the items.
Measured: At 0 weeks
Pediatric Neuromuscular Recovery Scale (Peds NRS)
The Pediatric Neuromuscular Recovery Scale (Peds NRS) assesses the quality of functional movement in children with MMC ages 1-12years. The Peds NRS examines the quality of sitting, upper extremity function, standing, and walking.The examiner administers the Peds NRS using a height-adjustable bench, mat table, fine motor manipulatives, and a ball. The examiner scores each of the 13 items on the Peds NRS on a 12-point scale, with one point allocated to each of the 12 phases of the item. The examiner scores the highest phase achieved by the child. A summary score is obtained using the sum of the items.
Measured: At 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Feb 2022
- Study start6 May 2021
- Primary completion8 Jul 2021
- Study completion8 Jul 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Spina Bifida With HydrocephalusStudies 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
- Not applicable
- Intervention model
- Single group
- Model description
- Single participant case study
- Masking
- None (open label)
- Enrolment
- 1 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of St. Augustine for Health Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Marianne Hanover, PT, DPT, University of St. Augustine for Health Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05251740
- Sponsor's protocol ID
- 0329-21
- Status last verified
- Feb 2022
- First submitted
- 20 Jan 2022
- Last updated
- 23 Feb 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Yes: Plan to include goniometric and Peds NRS results and describe the protocol used
Study at a glance
From the registry record, last updated by the sponsor on 23 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of a Standing Program in a Child With Spina Bifida: A Case Report
- ClinicalTrials.gov ID
- NCT05251740
- Acronym / sponsor ID
- 0329-21
- Conditions
- Spina Bifida With Hydrocephalus
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1 participants (actual)
- Lead sponsor
- University of St. Augustine for Health SciencesUniversity, hospital or other
- Study start
- 6 May 2021 (actual)
- Primary completion
- 8 Jul 2021 (actual)
- Study completion
- 8 Jul 2021 (actual)
- First posted
- 23 Feb 2022 (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 case study is to investigate a child with MMC who has significant knee and hip flexion contractures to answer the following research questions: 1) Is a home standing program effective in reducing hip and knee flexion contractures in a child with MMC? 2) Does a home standing program result in a change in the quality of functional movement?
A Physical therapist, PT, will administer the Peds NRS and goniometric measurements prior to the start of the study and at the end of the study. The PT will also provide the parent instruction on the standing home program with weekly check-ins to ensure the parent and child are able to follow the home program. The home standing program will last 8 weeks. The parent will keep a written log of stander use. The Peds NRS scores and goniometric measurements will be compared pre and post intervention. The expected outcome is that the Peds NRS scores and hip and knee extension range of motion measurements will improve.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Single participant case study
| Arm | Type | Receives |
|---|---|---|
| Standing program | Experimental | Device: Altimate Medical EasyStand BantamThe child completes a 60-minute home standing program five days per week over eight weeks. |
Who may qualify
- Ages
- 9 to 9 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- diagnosis of Spina Bifida
- be able to stand with an assistive device
Key exclusion criteria (2 listed)
- a diagnosis unrelated to Spina Bifida that limits standing
- medical restrictions that contraindicate standing
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 BantamThe child will stand in the device for 60 min per day, 5 days per week for 2 months. | Device | Standing program |
Primary outcome
Goniometric measurements
Time frame: At 0 weeks
A universal goniometer will be used to measure the child's hip and knee joint passive ranges of motion (PROM).
Goniometric measurements
Time frame: At 8 weeks
A universal goniometer will be used to measure the child's hip and knee joint passive ranges of motion (PROM).
Pediatric Neuromuscular Recovery Scale (Peds NRS)
Time frame: At 0 weeks
The Pediatric Neuromuscular Recovery Scale (Peds NRS) assesses the quality of functional movement in children with MMC ages 1-12years. The Peds NRS examines the quality of sitting, upper extremity function, standing, and walking.The examiner administers the Peds NRS using a height-adjustable bench, mat table, fine motor manipulatives, and a ball. The examiner scores each of the 13 items on the Peds NRS on a 12-point scale, with one point allocated to each of the 12 phases of the item. The examiner scores the highest phase achieved by the child. A summary score is obtained using the sum of the items.
Pediatric Neuromuscular Recovery Scale (Peds NRS)
Time frame: At 8 weeks
The Pediatric Neuromuscular Recovery Scale (Peds NRS) assesses the quality of functional movement in children with MMC ages 1-12years. The Peds NRS examines the quality of sitting, upper extremity function, standing, and walking.The examiner administers the Peds NRS using a height-adjustable bench, mat table, fine motor manipulatives, and a ball. The examiner scores each of the 13 items on the Peds NRS on a 12-point scale, with one point allocated to each of the 12 phases of the item. The examiner scores the highest phase achieved by the child. A summary score is obtained using the sum of the items.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Feb 2022.
- Individual participant dataSharing planned: Yes. Plan to include goniometric and Peds NRS results and describe the protocol used
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.
The record lists no contact. Use the official record to reach the sponsor.
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 With Hydrocephalus, 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 2 inclusion and 2 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: finished, as of the sponsor's last update on 23 Feb 2022. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Goniometric measurements (time frame: At 0 weeks). The study lists 4 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 23 Feb 2022.