User Satisfaction of an Instrumented Standing Frame

NCT06033885 | Completed

• 1 other identifier: 11.928
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Functional Disability

Keywords

Children; Adolescents; Standing frame

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• The three most important aspects of patient satisfaction with an instrumented standing frame

  8 weeks difference in change score between the control period and intervention period

• Usability of an instrumented standing frame

  8 weeks difference in change score between the control period and intervention period

• Health-related quality of life

  8 weeks difference in change score between the control period and intervention period

• Changes in prescription from the prescribing therapist

  8 weeks difference in change score between the control period and intervention period

Other Outcomes (2)

• Patient satisfaction with assistive device service of an instrumented standing frame

  8 weeks difference in change score between the control period and intervention period

• Patient satisfaction with PONDUS®

  4 weeks score from the intervention period

Study Arms (1)

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.

Device: PONDUS®

Interventions

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.

4-week control period + 4-week intervention period

Eligibility Criteria

• Age: 3 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Children with disabilities aged 3-17 years who uses a standing frame
• Informed consent from parents
• Informed consent from children aged 15-17 years

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Southern Denmark: lead
• R82 A/S: collaborator
• Innovation Fund Denmark: collaborator

Study Sites (1)

University of Southern Denmark

Odense C, 5000, Denmark

Location

Related Publications (18)

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  PMID: 26517269 BACKGROUND

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Study Officials

• Anders Holsgaard-Larsen, Professor

  Department of Clinical Research, SDU & Department of Orthopaedics and Traumatology, OUH

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 5, 2023
• First Posted: September 13, 2023
• Study Start: January 15, 2024
• Primary Completion: June 20, 2024
• Study Completion: June 20, 2024
• Last Updated: June 24, 2024

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will not share

Locations

DK (1)