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Applicability of a walker in healthy volunteers of different ages and levels of activity

Organizational Data

DRKS-ID:
DRKS00013728
Recruitment Status:
Recruiting complete, study complete
Date of registration in DRKS:
2018-02-16
Last update in DRKS:
2018-02-16
Registration type:
Retrospective

Acronym/abbreviation of the study

No Entry

URL of the study

No Entry

Brief summary in lay language

Walkers are removable. Therefore walkers allow early physiotherapy and regular wound control. Accordingly, the volume of prescriptions is increasing. The handling of a walker is mostly under the patient's autonomous control. The prerequisite of a walker is the autonomous and appropriate application by the patient. Aim of this study was to investigate patient handling safety of a walker in a broad patient collective.

Brief summary in scientific language

Various pathologies affecting the foot and ankle require immobilization. Immobilization can be achieved by various means, including white or soft cast, splint or walker. Over the last decade, walkers have become increasingly popular. This could be due to various advantages of walkers compared to traditional casting. First, walkers are removable and therefore allow early physiotherapy and regular wound control. Second, they allow full weightbearing due to a durable plastic shell and sole. Third, most walkers are adjustable and therefore can be adapted to current soft tissue conditions. The prerequisites for all these benefits is an easy and safe patient handling of the walker as it is removed and reapplied by the patient. Especially elderly patients might face difficulties due to visual impairment, reduced muscle strength (sarcopenia) or limited ROM (range of motion). No study has jet investigated general patient safety for any walker. Therefore, the aim of this study was to investigate patient handling safety of a commonly prescripted walker (VACO®ped) in a brought sample.

Health condition or problem studied

Free text:
healthy subjects
Healthy volunteers:
Yes

Interventions, Observational Groups

Arm 1:
Healthy volunteers of different ages and levels of activity are being researched at two different times (t0, t1). During the first investigation (t0) the volunteers are being taught in the handling of the walker (VACO®ped) in small groups of 4. Afterwards the volunteers are asked for applying the walker on their own, as previously learned. Wether the volunteers are doing every important step of the application procedure is controlled by the help of an 8-step protocol. Next is the measurement of strap tightness and heel lift-off. Strap tightness will be assessed as the penetration depth of a wedge at a constant force of 2 kg (20N). The wedge is inserted between the strap and the top cover of the boot and the penetration depth of the wedge is being measured in centimeters. To check the heel mobility, the volunteer is asked to lift the heel as far as possible within the walker. The distance between the heel and the bottom of the walker is assessed in centimeters. Finally the volunteers are asked to subjectivly judge, whether the walker was applied correctly (right/false) and if the application was easy or difficult. One to two weeks after the first investigation (t1) the investigation is repeated by the same volunteers without being instructed first.

Endpoints

Primary outcome:
Primary Outcome is the 8 - Point Application Score. First measurement point is the day of study inclusion (t0). Second measurement point is 1 to 2 weeks after t0 (t1). The primary outcome parameter is determined by a protocol. On the basis of this protocol (consisting of 8 subitems, dichotomous scaled) it will be checked whether the volunteer is doing every important substep of the application procedure.
Secondary outcome:
Secondary Outcome are strap tightness, heel lift-off and subjective judgement of the volunteers on the proper application and handling experience. First measurement point is the day of study inclusion (t0). Second measurement point is 1 to 2 weeks after t0 (t1). Strap tightness is measured as the penetration depth of a wedge. The wedge is inserted between strap and top cover of the boot at a constant force of 20N (2kg). The penetration depth of the wedge in centimeters reflects the strap tightness. Heel lift-off is also measured in centimeters. The distance between heel and sole of the boot is measured with the help of a prefabricated tool in 0,5 increments. The subjective judgement on the correct application and handling experience is asked by means of a dichotomous scaled questionnaire (right/false or rather easy/difficult).

Study Design

Purpose:
No Entry
Retrospective/prospective:
No Entry
Study type:
Non-interventional
Longitudinal/cross-sectional:
No Entry
Study type non-interventional:
No Entry

Recruitment

Recruitment Status:
Recruiting complete, study complete
Reason if recruiting stopped or withdrawn:
No Entry

Recruitment Locations

Recruitment countries:
  • Germany
Number of study centers:
Monocenter study
Recruitment location(s):
  • Other München

Recruitment period and number of participants

Planned study start date:
No Entry
Actual study start date:
2017-02-01
Planned study completion date:
No Entry
Actual Study Completion Date:
2017-03-31
Target Sample Size:
30
Final Sample Size:
33

Inclusion Criteria

Sex:
All
Minimum Age:
18 Years
Maximum Age:
95 Years
Additional Inclusion Criteria:
Age between 18 and 95 years; Informed consent; No musculoskeletal impairment within the last six months.

Exclusion Criteria

Cognitive, neurological or obvious physical impairment. Acute impairment of the foot and ankle within the last 6 months. Pregnancy. Inability to give informed consent.

Addresses

Primary Sponsor

Klinik für Allgemeine, Unfall- und Wiederherstellungschirugie, Klinikum der Universität (LMU) München
Priv.-Doz. Dr. med. Hans Polzer
Nussbaumstr. 20
80336 München
Germany
Telephone:
089 4400 52663
Fax:
No Entry
Contact per E-Mail
URL:
No Entry
Investigator Sponsored/Initiated Trial (IST/IIT):
Yes

Contact for Scientific Queries

Klinik für Allgemeine, Unfall- und Wiederherstellungschirugie, Klinikum der Universität (LMU) München
Priv.-Doz. Dr. med. Hans Polzer
Nussbaumstr. 20
80336 München
Germany
Telephone:
089 4400 52663
Fax:
No Entry
Contact per E-Mail
URL:
No Entry

Contact for Public Queries

Klinik für Allgemeine, Unfall- und Wiederherstellungschirurgie, Klinikum der Universität (LMU) München
Dr. med. Sebastian Felix Baumbach
Nussbaumstr. 20
80336 München
Germany
Telephone:
089 4400 52663
Fax:
No Entry
Contact per E-Mail
URL:
No Entry

Principal Investigator

Klinik für Allgemeine, Unfall- und Wiederherstellungschirugie, Klinikum der Universität (LMU) München
Priv.-Doz. Dr. med. Hans Polzer
Nussbaumstr. 20
80336 München
Germany
Telephone:
089 4400 52663
Fax:
No Entry
Contact per E-Mail
URL:
No Entry

Sources of Monetary or Material Support

Institutional budget, no external funding (budget of sponsor/PI)

Klinik für Allgemeine, Unfall- und Wiederherstellungschirurgie
Nussbaumstr. 20
80336 München
Germany
Telephone:
No Entry
Fax:
No Entry
Contact per E-Mail
URL:
No Entry

Ethics Committee

Address Ethics Committee

Ethikkommission der Med. Fakultät der LMU
Pettenkoferstraße 8
80336 München
Germany
Telephone:
+49-89-440055191
Fax:
+49-89-440055192
Contact per E-Mail
URL:
No Entry

Vote of leading Ethics Committee

Date of ethics committee application:
2016-12-14
Ethics committee number:
782-16
Vote of the Ethics Committee:
Approved
Date of the vote:
2017-01-31

Further identification numbers

Other primary registry ID:
No Entry
EudraCT Number:
No Entry
UTN (Universal Trial Number):
No Entry
EUDAMED 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 Entry
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:
No Entry
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