Functional DisabilityNCT06033885
User Satisfaction of an Instrumented Standing Frame
A study testing PONDUS® in people with Functional Disability, run by University of Southern Denmark at 1 site in Denmark.
Trial summary
Standing frames have existed for a long time and are well-established medical devices used to allow weight bearing in standing for persons who are unable to stand independently. Documenting the effectiveness of interventions using standing frames is complex. Read more about this study
- Who is it for?
- Ages 3 to 17 years
- Conditions the study is for
- Functional Disability
- What is being tested?
- PONDUS®
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteDenmark
- Study dates
- 15 Jan 2024to 20 Jun 2024
- 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 3 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Children with disabilities aged 3-17 years who uses a standing frame
- Informed consent from parents
- Informed consent from children aged 15-17 years
Who cannot join
- Earlier interventions in the form of orthopedic surgery within the past 52 weeks
- Injections with botulinum toxin type A in the 12 weeks prior to baseline assessments
- Insufficient co-operation and cognitive understanding to participate in the study
- Planned interventions in form of orthopedic surgery and/or botulinum toxin type A in the study period
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Changes in User Satisfaction and Quality of Life Following 4 Weeks of Instrumented Standing Frame Intervention in Children With Disabilities - a Feasibility Intervention Study
Standing frames have existed for a long time and are well-established medical devices used to allow weight bearing in standing for persons who are unable to stand independently.
Documenting the effectiveness of interventions using standing frames is complex. The current evidence base for their use is limited due to studies of low to moderate quality and small effects documented.
Read more
Providing real-time feed-back on force and position and thus continuous tracking of the intensity allows for informed decision making about the support provided by the standing frame in clinical settings, thereby making it possible to document the potential setup for optimal support and potential association between the intensity and positive effects of the standing frames.
The objective of the study is to document potential short-term benefits on a) patient satisfaction and health-related quality of life and b) changes in prescription from the prescribing therapist of the use of standing frames in children with standing disabilities when PONDUS®, a digital product used to assess the force applied during standing in a R82 standing frame is applied opposed to current practice.
The study is a one-arm feasibility intervention study using participants as their own controls. The study will include 15 children with functional disabilities who currently uses a standing frame.
Read the detailed description
Most children stand independently by the age of 11 month, allowing them to apply different loads on their bones, joints, and muscles, and experience their surroundings from a new perspective. Children who do not reach the motor milestone "standing" in early childhood should have access to assistive medical devices such as standing frames, which enable them to gain benefits of the standing position as typically developing children.
Standing frames have existed for a long time and are well-established medical devices used to allow weight bearing in standing for persons who are unable to stand independently. The frame supports the child with upholstered plates and straps around the legs, trunk and/or head and is often positioned in an almost vertical posture, allowing the user partial weight bearing on their lower extremities. The devices are widely used as part of postural management for persons with disability and a population-based study in Sweden shows that 31% of all children with cerebral palsy use external support to stand.
Documenting the effectiveness of interventions using standing frames is complex. The current evidence base for their use is limited due to studies of low to moderate quality and small effects documented. A systematic review and recent studies on the potential benefits of using standing frames indicate improvements in a range of functions and activities including: mental functions, bone and joint development and health, cardiovascular and respiratory systems, digestive systems and urinary functions, neuromusculoskeletal and movement related functions, pain, mobility, the ability to maintain a sitting or standing position, and major life areas, including interaction with peers. Importantly, the studies did not report adverse events or serious harm.
The above studies reveal a large variety in dosing in terms of frequency and time of use of the standing frames from <1 to 7 days per week, 1 or more sessions per day and <30 min to >120 min per session. Importantly, none of the studies document dosing in terms of intensity assessed as the degree of weight bearing while using a standing frame. Multiple variables such as type of frame, use of supports, inclination, activities performed while standing and inclination of the frame have been suggested to affect weight bearing in standing frames. Instrumented standing frames have been used in experimental settings and have documented a large variation in percentage of body weight from 23-133%, which could indicate serious issues of controlling the intensity or even misuse and/or measurement error. To our knowledge, instrumented standing frames that can assess force and position during the use of a standing frames is currently not available for use in clinical practice.
The lack of information about force and position during the use of standing frames in clinical settings makes it impossible to document the potential setup for optimal support and potential association between the intensity and positive effects of the standing frames and, moreover, whether the intensity of the intervention should be tailored to the individual child.
Providing real-time feed-back on force and position and thus continuous tracking of the intensity allows for informed decision making about the support provided by the standing frame in a clinical setting.
The purpose of this study is to document potential short-term benefits on a) patient satisfaction and health-related quality of life and b) changes in prescription from the prescribing therapist of the use of standing frames in children with standing disabilities when PONDUS®, a digital product used to assess the force applied during standing in a R82 standing frame, is applied opposed to current practice.
The study is a one-arm feasibility intervention study using participants as their own controls. The study will be conducted in special day-care centers and schools or in the children's home. Participants will be 15 children with functional disabilities in the age of 3-17 years who currently uses a standing frame.
Recruitment will be conducted in collaboration with the study's commercial partner's distributor network and special day-care centers and schools across Denmark, that will assist in identifying possible study participants. In addition to the above parents will be reached through advocacy organizations or on social medias with an invitation for participation in the studies.
Prior to the intervention a 4-week control period, where the non-instrumented standing frame is used according to standard practice, will be carried out. Subsequently, a 4-week intervention period, where the standing frame is instrumented (PONDUS®) allowing continued monitoring and adjustments of the force and position during sessions will be conducted. Changes in outcome measures will be evaluated as the difference in within-group change score between the control period and intervention period.
Participation in the study will be voluntary and all participants will be informed that even after the eventual acceptance of participation, at any stage of the project they may decide to discontinue participation in the trial without giving any reason and without it having consequences for further treatment.
- Conditions
- Functional Disability
- Being tested
- PONDUS®
- Keywords
- Children, Adolescents, Standing frame
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PONDUS®Device
PONDUS® is a CE-marked medical device to support the positioning of the user in a R82 standing frame.
PONDUS® is designed as a pair of instrumented foot plates and an app as an external display.
PONDUS® gives individual readings from the right and the left plate telling how much force is applied to each plate by combining high frequency data from three pressure sensors in each plate. The data is displayed in the app as a time series graph and can also be exported.
| Study group | Role | What they receive |
|---|---|---|
| 4-week control period + 4-week intervention period | Experimental | Prior to the intervention a 4-week control period, where the non-instrumented standing frame is used according to current practice, will be carried out. Subsequently, a 4-week intervention period, where the standing frame is instrumented (PONDUS®) allowing continued adjustments of the force and position within and between sessions will be conducted. Receives: Device: PONDUS® |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient satisfaction with an instrumented standing frame
Patient satisfaction with an instrumented standing frame will be assessed with the Quebec User Evaluation of Satisfaction with Assistive Technology (Quest 2.0) questionnaires eight items assessing characteristics of the assistive device in terms of the following dimensions: 1) dimensions (size), 2. weight, 3. adjustments, 4. safety, 5. durability, 6. simplicity of use, 7. comfort and 8. effectiveness.
For each item, the questionnaire uses a 5point scale, 1 being not satisfied at all and 5 being very satisfied.
Measured: 8 weeks difference in change score between the control period and intervention period
Secondary outcomes (4)
The three most important aspects of patient satisfaction with an instrumented standing frame
Through user involvement, the three key aspects of patient satisfaction with an instrumented standing frame will be selected from the Quebec User Evaluation of Satisfaction with Assistive Technology (Quest 2.0) questionnaire
Measured: 8 weeks difference in change score between the control period and intervention period
Usability of an instrumented standing frame
Usability of an instrumented standing frame will be assessed with the Usefulness, Satisfaction, and Ease of use (USE) Questionnaire.
For each item, the questionnaire uses a 7 point Likert rating scales, with 1 = Strongly disagree to 7 = Strongly agree.
Measured: 8 weeks difference in change score between the control period and intervention period
Health-related quality of life
Health-related quality of life will be assessed with the Caregiver Priorities and Child Health Index of Life with Disabilities (CPCHILD) questionnaire.
Scores for each domain and for the total survey are standardized and range from 0 (worse) to 100 (best).
Measured: 8 weeks difference in change score between the control period and intervention period
Changes in prescription from the prescribing therapist
Changes in prescription from the prescribing therapist of the use of the standing frame when PONDUS® is applied opposed to current practice will be assessed with a self-constructed questionnaire made for the purpose
Measured: 8 weeks difference in change score between the control period and intervention period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Sep 2023
- Study start15 Jan 2024
- Primary completion20 Jun 2024
- Study completion20 Jun 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (18)Papers the sponsor has linked to this study.
- Other trials for Functional DisabilityStudies of the same condition, open and under way.
- More trials run by University of Southern DenmarkThe sponsor's other registered studies.
- 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
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Southern Denmark
- Sponsor type
- University, hospital or other
- Collaborators
- R82 A/S, Innovation Fund Denmark
- Responsible party
- Sponsor
- Investigators
- Anders Holsgaard-Larsen, Professor, Principal investigator, Department of Clinical Research, SDU & Department of Orthopaedics and Traumatology, OUH
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06033885
- Sponsor's protocol ID
- 11.928
- Status last verified
- Jun 2024
- First submitted
- 5 Sep 2023
- Last updated
- 24 Jun 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Due to ethical and legal considerations, our data cannot be shared publicly. This is due to the restrictions from the Regional and the National Committee on Health Research Ethics and the General Data Protection Regulation (EU) 2016/679, since the data contains person-specific information on birth date, sex, and diagnosis classification among other. Data are available for researchers who meet the criteria for access to confidential data. Access may be acquired through contact to the research group.
Publications
WHO Multicentre Growth Reference Study Group. WHO Motor Development Study: windows of achievement for six gross motor development milestones. Acta Paediatr Suppl. 2006 Apr;450:86-95. doi: 10.1111/j.1651-2227.2006.tb02379.x.
PubMed 16817682Wijnhoven TM, de Onis M, Onyango AW, Wang T, Bjoerneboe GE, Bhandari N, Lartey A, al Rashidi B. Assessment of gross motor development in the WHO Multicentre Growth Reference Study. Food Nutr Bull. 2004 Mar;25(1 Suppl):S37-45. doi: 10.1177/15648265040251S105.
PubMed 15069918Goodwin J, Lecouturier J, Smith J, Crombie S, Basu A, Parr JR, Howel D, McColl E, Roberts A, Miller K, Cadwgan J. Understanding frames: A qualitative exploration of standing frame use for young people with cerebral palsy in educational settings. Child Care Health Dev. 2019 May;45(3):433-439. doi: 10.1111/cch.12659.
PubMed 30883842Paleg GS, Smith BA, Glickman LB. Systematic review and evidence-based clinical recommendations for dosing of pediatric supported standing programs. Pediatr Phys Ther. 2013 Fall;25(3):232-47. doi: 10.1097/PEP.0b013e318299d5e7.
PubMed 23797394Rodby-Bousquet E, Hagglund G. Sitting and standing performance in a total population of children with cerebral palsy: a cross-sectional study. BMC Musculoskelet Disord. 2010 Jun 23;11:131. doi: 10.1186/1471-2474-11-131.
PubMed 20573201Rivi E, Filippi M, Fornasari E, Mascia MT, Ferrari A, Costi S. Effectiveness of standing frame on constipation in children with cerebral palsy: a single-subject study. Occup Ther Int. 2014 Sep;21(3):115-23. doi: 10.1002/oti.1370. Epub 2014 May 16.
PubMed 24838311Capati V, Covert SY, Paleg G. Stander Use for an Adolescent with Cerebral Palsy at GMFCS Level with Hip and Knee Contractures. Assist Technol. 2020 Nov 1;32(6):335-341. doi: 10.1080/10400435.2019.1579268. Epub 2019 Apr 4.
PubMed 30945990Han EY, Choi JH, Kim SH, Im SH. The effect of weight bearing on bone mineral density and bone growth in children with cerebral palsy: A randomized controlled preliminary trial. Medicine (Baltimore). 2017 Mar;96(10):e5896. doi: 10.1097/MD.0000000000005896.
PubMed 28272197Macias-Merlo L, Bagur-Calafat C, Girabent-Farres M, A Stuberg W. Effects of the standing program with hip abduction on hip acetabular development in children with spastic diplegia cerebral palsy. Disabil Rehabil. 2016;38(11):1075-81. doi: 10.3109/09638288.2015.1100221. Epub 2015 Oct 30.
PubMed 26517269Macias-Merlo L, Bagur-Calafat C, Girabent-Farres M, Stuberg WA. Standing Programs to Promote Hip Flexibility in Children With Spastic Diplegic Cerebral Palsy. Pediatr Phys Ther. 2015 Fall;27(3):243-9. doi: 10.1097/PEP.0000000000000150.
PubMed 26020594Hough JP, Boyd RN, Keating JL. Systematic review of interventions for low bone mineral density in children with cerebral palsy. Pediatrics. 2010 Mar;125(3):e670-8. doi: 10.1542/peds.2009-0292. Epub 2010 Feb 1.
PubMed 20123765Salem Y, Lovelace-Chandler V, Zabel RJ, McMillan AG. Effects of prolonged standing on gait in children with spastic cerebral palsy. Phys Occup Ther Pediatr. 2010 Feb;30(1):54-65. doi: 10.3109/01942630903297177.
PubMed 20170432Curtis DJ, Woollacott M, Bencke J, Lauridsen HB, Saavedra S, Bandholm T, Sonne-Holm S. The functional effect of segmental trunk and head control training in moderate-to-severe cerebral palsy: A randomized controlled trial. Dev Neurorehabil. 2018 Feb;21(2):91-100. doi: 10.1080/17518423.2016.1265603. Epub 2017 Jan 3.
PubMed 28045553Curtis DJ, Butler P, Saavedra S, Bencke J, Kallemose T, Sonne-Holm S, Woollacott M. The central role of trunk control in the gross motor function of children with cerebral palsy: a retrospective cross-sectional study. Dev Med Child Neurol. 2015 Apr;57(4):351-7. doi: 10.1111/dmcn.12641. Epub 2014 Nov 20.
PubMed 25412902Pedlow K, McDonough S, Lennon S, Kerr C, Bradbury I. Assisted standing for Duchenne muscular dystrophy. Cochrane Database Syst Rev. 2019 Oct 13;10(10):CD011550. doi: 10.1002/14651858.CD011550.pub2.
PubMed 31606891
Study at a glance
From the registry record, last updated by the sponsor on 24 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Changes in User Satisfaction and Quality of Life Following 4 Weeks of Instrumented Standing Frame Intervention in Children With Disabilities - a Feasibility Intervention Study
- ClinicalTrials.gov ID
- NCT06033885
- Acronym / sponsor ID
- 11.928
- Conditions
- Functional Disability
- Keywords
- Children, Adolescents, Standing frame
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- University of Southern DenmarkUniversity, hospital or other
- Collaborators
- R82 A/S, Innovation Fund Denmark
- Study start
- 15 Jan 2024 (actual)
- Primary completion
- 20 Jun 2024 (actual)
- Study completion
- 20 Jun 2024 (actual)
- First posted
- 13 Sep 2023 (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.
Standing frames have existed for a long time and are well-established medical devices used to allow weight bearing in standing for persons who are unable to stand independently.
Documenting the effectiveness of interventions using standing frames is complex. The current evidence base for their use is limited due to studies of low to moderate quality and small effects documented.
Providing real-time feed-back on force and position and thus continuous tracking of the intensity allows for informed decision making about the support provided by the standing frame in clinical settings, thereby making it possible to document the potential setup for optimal support and potential association between the intensity and positive effects of the standing frames.
The objective of the study is to document potential short-term benefits on a) patient satisfaction and health-related quality of life and b) changes in prescription from the prescribing therapist of the use of standing frames in children with standing disabilities when PONDUS®, a digital product used to assess the force applied during standing in a R82 standing frame is applied opposed to current practice.
The study is a one-arm feasibility intervention study using participants as their own controls. The study will include 15 children with functional disabilities who currently uses a standing frame.
Detailed description
Most children stand independently by the age of 11 month, allowing them to apply different loads on their bones, joints, and muscles, and experience their surroundings from a new perspective. Children who do not reach the motor milestone "standing" in early childhood should have access to assistive medical devices such as standing frames, which enable them to gain benefits of the standing position as typically developing children.
Standing frames have existed for a long time and are well-established medical devices used to allow weight bearing in standing for persons who are unable to stand independently. The frame supports the child with upholstered plates and straps around the legs, trunk and/or head and is often positioned in an almost vertical posture, allowing the user partial weight bearing on their lower extremities. The devices are widely used as part of postural management for persons with disability and a population-based study in Sweden shows that 31% of all children with cerebral palsy use external support to stand.
Documenting the effectiveness of interventions using standing frames is complex. The current evidence base for their use is limited due to studies of low to moderate quality and small effects documented. A systematic review and recent studies on the potential benefits of using standing frames indicate improvements in a range of functions and activities including: mental functions, bone and joint development and health, cardiovascular and respiratory systems, digestive systems and urinary functions, neuromusculoskeletal and movement related functions, pain, mobility, the ability to maintain a sitting or standing position, and major life areas, including interaction with peers. Importantly, the studies did not report adverse events or serious harm.
The above studies reveal a large variety in dosing in terms of frequency and time of use of the standing frames from <1 to 7 days per week, 1 or more sessions per day and <30 min to >120 min per session. Importantly, none of the studies document dosing in terms of intensity assessed as the degree of weight bearing while using a standing frame. Multiple variables such as type of frame, use of supports, inclination, activities performed while standing and inclination of the frame have been suggested to affect weight bearing in standing frames. Instrumented standing frames have been used in experimental settings and have documented a large variation in percentage of body weight from 23-133%, which could indicate serious issues of controlling the intensity or even misuse and/or measurement error. To our knowledge, instrumented standing frames that can assess force and position during the use of a standing frames is currently not available for use in clinical practice.
The lack of information about force and position during the use of standing frames in clinical settings makes it impossible to document the potential setup for optimal support and potential association between the intensity and positive effects of the standing frames and, moreover, whether the intensity of the intervention should be tailored to the individual child.
Providing real-time feed-back on force and position and thus continuous tracking of the intensity allows for informed decision making about the support provided by the standing frame in a clinical setting.
The purpose of this study is to document potential short-term benefits on a) patient satisfaction and health-related quality of life and b) changes in prescription from the prescribing therapist of the use of standing frames in children with standing disabilities when PONDUS®, a digital product used to assess the force applied during standing in a R82 standing frame, is applied opposed to current practice.
The study is a one-arm feasibility intervention study using participants as their own controls. The study will be conducted in special day-care centers and schools or in the children's home. Participants will be 15 children with functional disabilities in the age of 3-17 years who currently uses a standing frame.
Recruitment will be conducted in collaboration with the study's commercial partner's distributor network and special day-care centers and schools across Denmark, that will assist in identifying possible study participants. In addition to the above parents will be reached through advocacy organizations or on social medias with an invitation for participation in the studies.
Prior to the intervention a 4-week control period, where the non-instrumented standing frame is used according to standard practice, will be carried out. Subsequently, a 4-week intervention period, where the standing frame is instrumented (PONDUS®) allowing continued monitoring and adjustments of the force and position during sessions will be conducted. Changes in outcome measures will be evaluated as the difference in within-group change score between the control period and intervention period.
Participation in the study will be voluntary and all participants will be informed that even after the eventual acceptance of participation, at any stage of the project they may decide to discontinue participation in the trial without giving any reason and without it having consequences for further treatment.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 4-week control period + 4-week intervention period | Experimental | Device: PONDUS®Prior to the intervention a 4-week control period, where the non-instrumented standing frame is used according to current practice, will be carried out. Subsequently, a 4-week intervention period, where the standing frame is instrumented (PONDUS®) allowing continued adjustments of the force and position within and between sessions will be conducted. |
Who may qualify
- Ages
- 3 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Children with disabilities aged 3-17 years who uses a standing frame
- Informed consent from parents
- Informed consent from children aged 15-17 years
Key exclusion criteria (4 listed)
- Earlier interventions in the form of orthopedic surgery within the past 52 weeks
- Injections with botulinum toxin type A in the 12 weeks prior to baseline assessments
- Insufficient co-operation and cognitive understanding to participate in the study
- Planned interventions in form of orthopedic surgery and/or botulinum toxin type A in the study period
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 |
|---|---|---|
| PONDUS®PONDUS® is a CE-marked medical device to support the positioning of the user in a R82 standing frame. PONDUS® is designed as a pair of instrumented foot plates and an app as an external display. PONDUS® gives individual readings from the right and the left plate telling how much force is applied to each plate by combining high frequency data from three pressure sensors in each plate. The data is displayed in the app as a time series graph and can also be exported. | Device | 4-week control period + 4-week intervention period |
Primary outcome
Patient satisfaction with an instrumented standing frame
Time frame: 8 weeks difference in change score between the control period and intervention period
Patient satisfaction with an instrumented standing frame will be assessed with the Quebec User Evaluation of Satisfaction with Assistive Technology (Quest 2.0) questionnaires eight items assessing characteristics of the assistive device in terms of the following dimensions: 1) dimensions (size), 2. weight, 3. adjustments, 4. safety, 5. durability, 6. simplicity of use, 7. comfort and 8. effectiveness. For each item, the questionnaire uses a 5point scale, 1 being not satisfied at all and 5 being very satisfied.
4 secondary outcomes
The three most important aspects of patient satisfaction with an instrumented standing frame
Time frame: 8 weeks difference in change score between the control period and intervention period
Usability of an instrumented standing frame
Time frame: 8 weeks difference in change score between the control period and intervention period
Health-related quality of life
Time frame: 8 weeks difference in change score between the control period and intervention period
Changes in prescription from the prescribing therapist
Time frame: 8 weeks difference in change score between the control period and intervention period
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 24 Jun 2024.
- Background: PubMed 16817682WHO Multicentre Growth Reference Study Group. WHO Motor Development Study: windows of achievement for six gross motor development milestones. Acta Paediatr Suppl. 2006 Apr;450:86-95. doi: 10.1111/j.1651-2227.2006.tb02379.x.
- Background: PubMed 15069918Wijnhoven TM, de Onis M, Onyango AW, Wang T, Bjoerneboe GE, Bhandari N, Lartey A, al Rashidi B. Assessment of gross motor development in the WHO Multicentre Growth Reference Study. Food Nutr Bull. 2004 Mar;25(1 Suppl):S37-45. doi: 10.1177/15648265040251S105.
- Background: PubMed 30883842Goodwin J, Lecouturier J, Smith J, Crombie S, Basu A, Parr JR, Howel D, McColl E, Roberts A, Miller K, Cadwgan J. Understanding frames: A qualitative exploration of standing frame use for young people with cerebral palsy in educational settings. Child Care Health Dev. 2019 May;45(3):433-439. doi: 10.1111/cch.12659.
- Background: PubMed 23797394Paleg GS, Smith BA, Glickman LB. Systematic review and evidence-based clinical recommendations for dosing of pediatric supported standing programs. Pediatr Phys Ther. 2013 Fall;25(3):232-47. doi: 10.1097/PEP.0b013e318299d5e7.
- Background: PubMed 20573201Rodby-Bousquet E, Hagglund G. Sitting and standing performance in a total population of children with cerebral palsy: a cross-sectional study. BMC Musculoskelet Disord. 2010 Jun 23;11:131. doi: 10.1186/1471-2474-11-131.
- Background: PubMed 24838311Rivi E, Filippi M, Fornasari E, Mascia MT, Ferrari A, Costi S. Effectiveness of standing frame on constipation in children with cerebral palsy: a single-subject study. Occup Ther Int. 2014 Sep;21(3):115-23. doi: 10.1002/oti.1370. Epub 2014 May 16.
- Background: PubMed 30945990Capati V, Covert SY, Paleg G. Stander Use for an Adolescent with Cerebral Palsy at GMFCS Level with Hip and Knee Contractures. Assist Technol. 2020 Nov 1;32(6):335-341. doi: 10.1080/10400435.2019.1579268. Epub 2019 Apr 4.
- Background: PubMed 28272197Han EY, Choi JH, Kim SH, Im SH. The effect of weight bearing on bone mineral density and bone growth in children with cerebral palsy: A randomized controlled preliminary trial. Medicine (Baltimore). 2017 Mar;96(10):e5896. doi: 10.1097/MD.0000000000005896.
- Background: PubMed 26517269Macias-Merlo L, Bagur-Calafat C, Girabent-Farres M, A Stuberg W. Effects of the standing program with hip abduction on hip acetabular development in children with spastic diplegia cerebral palsy. Disabil Rehabil. 2016;38(11):1075-81. doi: 10.3109/09638288.2015.1100221. Epub 2015 Oct 30.
- Background: PubMed 26020594Macias-Merlo L, Bagur-Calafat C, Girabent-Farres M, Stuberg WA. Standing Programs to Promote Hip Flexibility in Children With Spastic Diplegic Cerebral Palsy. Pediatr Phys Ther. 2015 Fall;27(3):243-9. doi: 10.1097/PEP.0000000000000150.
- Background: PubMed 20123765Hough JP, Boyd RN, Keating JL. Systematic review of interventions for low bone mineral density in children with cerebral palsy. Pediatrics. 2010 Mar;125(3):e670-8. doi: 10.1542/peds.2009-0292. Epub 2010 Feb 1.
- Background: PubMed 20170432Salem Y, Lovelace-Chandler V, Zabel RJ, McMillan AG. Effects of prolonged standing on gait in children with spastic cerebral palsy. Phys Occup Ther Pediatr. 2010 Feb;30(1):54-65. doi: 10.3109/01942630903297177.
- Individual participant dataSharing planned: No. Due to ethical and legal considerations, our data cannot be shared publicly. This is due to the restrictions from the Regional and the National Committee on Health Research Ethics and the General Data Protection Regulation (EU) 2016/679, since the data contains person-specific information on birth date, sex, and diagnosis classification among other. Data are available for researchers who meet the criteria for access to confidential data. Access may be acquired through contact to the research group.
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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.
Anders Holsgaard-Larsen, Professor principal investigator
Department of Clinical Research, SDU & Department of Orthopaedics and Traumatology, OUH
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PONDUS® in people with Functional Disability, run by University of Southern Denmark at 1 site in Denmark.
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 3 inclusion and 4 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 24 Jun 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 Denmark. 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?
Patient satisfaction with an instrumented standing frame (time frame: 8 weeks difference in change score between the control period and intervention period). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06033885, which also lists 18 linked publications.
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 24 Jun 2024.