Validation of a prosthetic leg prototype aimed at increasing lateral balance control in prosthetic walking: a pilot study

Completed

• Conditions: Amputatie van de onderste extremiteit; Prosthetic walking; Leg amputation

• Registration Number: NL-OMON47150
• Lead Sponsor: niversitair Medisch Centrum Groningen

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 11 June 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 30

Inclusion Criteria

Amputee subjects (patients):
- written informed consent;
- Unilateral transfemoral amputation;
- Between 18 - 80 years old;
- Daily prosthetic use for at least one year;
- Mobility level at least 3 (as judged by medical professional);
- Ability to walk independently for an hour, e.g. without the use of walking aids;
- Clearance under prosthetic knee at least 35cm. ;Able-bodied reference group:
- Age matched with amputee group.

Exclusion Criteria

Self reported criteria of:
- Serious vascular problems or pain of the non-amputated limb;
- Musculoskeletal dysfunctions or disease (other than the amputation for amputees);
- Serious cardiac or pulmonary problems;
- Diseases that interfere with equilibrium (other than the amputation for amputees);
- Serious visual problems;
- Amblyacousia;
- Otitis media;
- Use of antipsychotic, sedative or antidepressant drugs (except amitriptyline);
- Use of other medication that interfere with equilibrium or cognition;
- Inability to cope with the new prosthetic set-up (see 7.3 and 7.7 of the research protocol).

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>This is a pilot study. Therefore, no main outcome parameters can be specified.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>na</p><br>