Outcome Iwalk 2.0 orthosis compared to using Unetrarm crutches on patients with (partial) relief after foot or ankle surgery

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

DRKS

Registry ID

DRKS00021487

Enrollment

Registered

2020-07-28

Start date

2020-06-17

Completion date

Unknown

Last updated

2026-03-30

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

Conditions

S92 S82

Interventions

Group 1: After the operation, patients are mobilized with the standard forearm crutch for the first 3 weeks and then with the iWalk 2.0 orthosis for the next 3 weeks. Group 2: After surgery, patients

Eligibility

Sex/Gender

All

Age

18 Years to 70 Years

Inclusion criteria

Inclusion criteria: - Indication for an orthopaedic intervention in the area of the middle or rear foot with subsequent relief - Age over 18 years and under 70 years - Secure one-legged stand on both sides. with straight pelvis position and without positive Trendelenburg sign

Exclusion criteria

Exclusion criteria: - Known balance disorders - BMI > 35 - Known or diagnosed osteoporosis - Pre-surgery on the upper and lower extremities that do not allow the use of crutches - Known substance abuse or dementia - Known cardiopulmonary diseases that restrict mobilisation - Known coordinative or neuromuscular diseases, which restrict mobilisation - NRS value for safety for both aids with less than 5 - More than 2 stumbling events on the EU standardised course

Design outcomes

Primary

Measure	Time frame
Comparison of iWalk 2.0 orthosis stumbling tendency vs. forearm crutches on an EU standard obstacle course (the interruption of gait is counted as a stumbling event) after 3 and 6 weeks. The interruption of gait pattern is counted as a tripping hazard.	—

Secondary

Measure	Time frame
- Gait speed by means of 10 meter walking test (10MWT), after 3 and 6 weeks - Gait endurance by means of 6 minute walking test (6MWT), after 3 and 6 weeks - Subjective perception of the aids using a visual analogue scale (VAS) at discharge, after 3 and 6 weeks - Collection of the questionnaires SF36, Short Musculoskeletal Function Assessment (SMFA) and EFAS on discharge, after 3 and 6 weeks	—

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: Apr 4, 2026