Fitness test of the IWalk 2.0 orthosis compared to the use of forearm crutches on healthy volunteers

Fitness test of the IWalk 2.0 orthosis compared to the use of forearm crutches on healthy volunteers - IWalk 2.0

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

DRKS

Registry ID

DRKS00014246

Enrollment

Registered

2020-02-19

Start date

2018-09-07

Completion date

Unknown

Last updated

2025-04-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

RELIEF AFTER ORTHOPEDIC INTERVENTIONS IN THE FOOT AREA

Interventions

Group 1: The following tests are carried out on healthy volunteers after 5 minutes of acclimatization to the forearm crutches: - Gait speed using a 10 meter walking test (10MWT) - Subjective satisfact

Eligibility

Sex/Gender

All

Age

18 Years to 70 Years

Inclusion criteria

Inclusion criteria: - Men and women - Age over 18 years and under 70 years - Safe one-leg stand on both sides with a straight pool stand and without a positive Trendelenburg sign

Exclusion criteria

Exclusion criteria: - Known balance disorders - BMI greater than 35 - known / diagnosed osteoporosis - Previous operations on the lower extremities - Known substance abuse or dementia

Design outcomes

Primary

Measure	Time frame
Evaluation of the tendency to trip on the EU-standardized course on the site of rehabilitation medicine. The interruption of the gait is counted as a stumbling event. On the day of the examination, the subject is informed by a doctor about the non-invasive study. The subject receives the subject information and has the opportunity to ask questions in order to resolve ambiguities. If the subject agrees in writing to participate in the study after providing sufficient information, the following standardized course of study will be followed. There is a review of the inclusion and exclusion criteria, as well as the randomization with regard to the sequence of the examinations and use of the aids (IWalk 2.0 orthosis vs. forearm crutches) in order to prevent possible bias due to fatigue.	—

Measure

Time frame

Evaluation of the tendency to trip on the EU-standardized course on the site of rehabilitation medicine. The interruption of the gait is counted as a stumbling event. On the day of the examination, the subject is informed by a doctor about the non-invasive study. The subject receives the subject information and has the opportunity to ask questions in order to resolve ambiguities. If the subject agrees in writing to participate in the study after providing sufficient information, the following standardized course of study will be followed. There is a review of the inclusion and exclusion criteria, as well as the randomization with regard to the sequence of the examinations and use of the aids (IWalk 2.0 orthosis vs. forearm crutches) in order to prevent possible bias due to fatigue.

—

Secondary

Measure	Time frame
- Gait speed using a 10 meter walking test (10MWT) - Subjective satisfaction based on questionnaires (to query comfort, safety and pain sensation) - Climb stairs - Indoor course "Waldboden" using standardized mats - Outdoor course with standardized obstacles (EFAP) - 6 minute walk test (6MWT) - Spirometer on the treadmill On the day of the examination, the subject is informed by a doctor about the non-invasive study. The subject receives the subject information and has the opportunity to ask questions in order to resolve ambiguities. If the subject agrees to study participation in writing after sufficient information, the following standardized course of study will be followed. There is a review of the inclusion and exclusion criteria, as well as the randomization with regard to the sequence of the examinations and use of the aids (IWalk 2.0 orthosis vs. forearm crutches) in order to prevent possible bias due to signs of fatigue.	—

Measure

Time frame

- Gait speed using a 10 meter walking test (10MWT) - Subjective satisfaction based on questionnaires (to query comfort, safety and pain sensation) - Climb stairs - Indoor course "Waldboden" using standardized mats - Outdoor course with standardized obstacles (EFAP) - 6 minute walk test (6MWT) - Spirometer on the treadmill On the day of the examination, the subject is informed by a doctor about the non-invasive study. The subject receives the subject information and has the opportunity to ask questions in order to resolve ambiguities. If the subject agrees to study participation in writing after sufficient information, the following standardized course of study will be followed. There is a review of the inclusion and exclusion criteria, as well as the randomization with regard to the sequence of the examinations and use of the aids (IWalk 2.0 orthosis vs. forearm crutches) in order to prevent possible bias due to signs of fatigue.

—

Countries

Germany

Contacts

Public ContactYvonne Noll

Orthopädische Klinik der Medizinischen Hochschule Hannover im Diakovere Annastift, Leitung Klinisches Studienmanagement

yvonne.noll@diakovere.de0511-5354-649

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Feb 4, 2026