Can real-time biofeedback help to better comply with an ordered partial load?
Organizational Data
- DRKS-ID:
- DRKS00031136
- Recruitment Status:
- Recruiting complete, study continuing
- Date of registration in DRKS:
- 2023-02-01
- Last update in DRKS:
- 2023-08-04
- Registration type:
- Retrospective
Acronym/abbreviation of the study
Partial Weight Bearing
URL of the study
No Entry
Brief summary in lay language
Can real-time biofeedback help to better comply with an given partial load?
Brief summary in scientific language
In recent years, there have been several attempts to monitor weight loading during ambulation. It was shown that subjects could not benefit from a discontinuous measurement method, and their compliance with a limited weight bearing regime were found to be poor (1-4). However, healing requires proper adherence to a prescribed partial load (5). Due to the costs and the high technical requirements, regular partial load training in a gait laboratory has not been implemented in the daily clinical routine. Technological progress has contributed to the development of commercially available ambulant insole measuring devices. Furthermore, modern devices can provide continuous real-time biofeedback on partial weight bearing in dynamic situations outside the gait laboratory and in the light of the assessment of overloads, an increase in studies dealing with different devices can be observed (6-11). Previous studies mostly used shoes to measure, but most follow-up treatment for injured lower limbs includes an orthosis, which means that the above studies do not apply in these cases. In this pilot study, the efficacy of a commercially available orthosis (SP Air Smart Walker, Sporlastic, Nuertingen, Germany) to improve body weight bearing was assessed in a group of healthy subjects. To the best of our knowledge, the present study is the first study that investigates the real load on an extremity with an insole force sensor in an unmodified orthosis. The aim of this study is to investigate whether subjects deviate from their specified load without biofeedback, and if so, to which extent they benefit from an activated biofeedback system.
Health condition or problem studied
- Free text:
- Lower extremity fractures prescribed partial weight bearing.
- Healthy volunteers:
- Yes
Interventions, Observational Groups
- Arm 1:
- The study has 2 arms. The first arm includes healthy subjects, the second arm includes patients. The study's objective is to test the measurement method on healthy volunteers first, and if the results are promising, to apply it to patients. Both arms have a control and an intervention group. The participants in the first arm (healthy volunteers) initially receive no biofeedback. This defines the control group. After the measurement (a course with a previously learned partial load), the same subjects receive biofeedback and go through the same course again. These measurement results are assigned to the intervention group. The results of both course runs are compared with each other.
- Arm 2:
- The second arm compares a control (no biofeedback) and intervention (with biofeedback) group to patients with ankle fractures only. The control and intervention groups are defined similarly to how arm 1 described them.
Endpoints
- Primary outcome:
- A measurement lasts for approximately 30 minutes. Running a course without and then with biofeedback is one type of measurement. The primary end point is the ending of the intervention group's run. This applies to both arms.
- Secondary outcome:
- Only the second arm contains the secondary endpoint. It is defined as the primary endpoint's conclusion plus two years. Patients will be contacted for a final exam, which will serve as the secondary endpoint. Clinical indicators like pain and range of motion are noted. The second endpoint is the conclusion of this study.
Study Design
- Purpose:
- Treatment
- Allocation:
- Non-randomized controlled study
- Control:
-
- Active control (effective treatment of control group)
- Phase:
- N/A
- Study type:
- Interventional
- Mechanism of allocation concealment:
- No Entry
- Blinding:
- No
- Assignment:
- Factorial
- Sequence generation:
- No Entry
- Who is blinded:
- No Entry
Recruitment
- Recruitment Status:
- Recruiting complete, study continuing
- Reason if recruiting stopped or withdrawn:
- No Entry
Recruitment Locations
- Recruitment countries:
-
- Germany
- Number of study centers:
- Monocenter study
- Recruitment location(s):
-
- Medical center Klinikum Stuttgart, Lehrkrankenhaus der Uni Tübingen Stuttgart
Recruitment period and number of participants
- Planned study start date:
- No Entry
- Actual study start date:
- 2022-03-01
- Planned study completion date:
- 2025-01-15
- Actual Study Completion Date:
- No Entry
- Target Sample Size:
- 59
- Final Sample Size:
- 59
Inclusion Criteria
- Sex:
- All
- Minimum Age:
- 18 Years
- Maximum Age:
- no maximum age
- Additional Inclusion Criteria:
- Inclusion criteria were sufficient upper-body coordination and strength to perform partial weight bearing with crutches and a minimum age of 18 years.
Exclusion Criteria
foot malformations, acute or chronic injuries or diseases, gait disorders due to muscle weakness, shoe sizes outside the measuring sole size (EU size 36–46), underweight (BMI < 18.5) and overweight (BMI > 30.0) individuals.
Addresses
Primary Sponsor
- Address:
- Klinikum StuttgartDr. med. Tobias MerkleKriegsbergstraße 6070174 StuttgartGermany
- Telephone:
- 49 711 278 54263
- Fax:
- 49 711 278 33649
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- http://www.klinikum-stuttgart.de
- Investigator Sponsored/Initiated Trial (IST/IIT):
- Yes
Contact for Scientific Queries
- Address:
- Klinikum StuttartDr. med. Tobias MerkleKriegstbergstraße 6070174 StuttgartGermany
- Telephone:
- 49 711 278 54263
- Fax:
- No Entry
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- No Entry
Contact for Public Queries
- Address:
- Klinikum StuttartDr. med. Tobias MerkleKriegstbergstraße 6070174 StuttgartGermany
- Telephone:
- 49 711 278 54263
- Fax:
- No Entry
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- No Entry
Principal Investigator
- Address:
- Klinikum StuttartDr. med. Tobias MerkleKriegstbergstraße 6070174 StuttgartGermany
- Telephone:
- 49 711 278 54263
- Fax:
- No Entry
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- No Entry
Sources of Monetary or Material Support
Institutional budget, no external funding (budget of sponsor/PI)
- Address:
- Klinikum Stuttgart70174 StuttgartGermany
- Telephone:
- No Entry
- Fax:
- No Entry
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- No Entry
Ethics Committee
Address Ethics Committee
- Address:
- Ethik-Kommission an der Medizinischen Fakultät der Eberhard-Karls-Universität und am Universitätsklinikum TübingenGartenstr. 4772074 TübingenGermany
- Telephone:
- +49-7071-2977661
- Fax:
- No Entry
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- No Entry
Vote of leading Ethics Committee
- Vote of leading Ethics Committee
- Date of ethics committee application:
- 2021-08-04
- Ethics committee number:
- 674/2021BO2
- Vote of the Ethics Committee:
- Approved
- Date of the vote:
- 2022-02-09
Further identification numbers
- Other primary registry ID:
- No Entry
- EudraCT Number:
- No Entry
IPD - Individual Participant Data
- Do you plan to make participant-related data (IPD) available to other researchers in an anonymized form?:
- No
- IPD Sharing Plan:
- No Entry
Study protocol and other study documents
- Study protocols:
- No Entry
- Study abstract:
- No Entry
- Other study documents:
- No Entry
- Background literature:
- No Entry
- Related DRKS studies:
- No Entry
Publication of study results
- Planned publication:
- Dezember 2023
- Publikationen/Studienergebnisse:
- No Entry
- Date of first publication of study results:
- No Entry
- DRKS entry published for the first time with results:
- No Entry
Basic reporting
- Basic Reporting / Results tables:
- No Entry
- Brief summary of results:
- No Entry