User Satisfaction of an Instrumented Standing Frame

Study Overview
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Brief Summary
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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
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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.

Official Title
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Changes in User Satisfaction and Quality of Life Following 4 Weeks of Instrumented Standing Frame Intervention in Children With Disabilities - a Feasibility Intervention Study

Conditions
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Functional Disability

Intervention / Treatment
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* Device: PONDUS®


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Children with disabilities aged 3-17 years who uses a standing frame Informed consent from parents Informed consent from children aged 15-17 years Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 3 Years
Maximum Age: 17 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 4-week control period + 4-week intervention period<br>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. | Device: PONDUS®<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 8 weeks difference in change score between the control period and intervention period | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 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. | 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). | 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 | 8 weeks difference in change score between the control period and intervention period | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Children, Adolescents, Standing frame