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Leg prosthesis to improve lateral balance

Validation of a prosthetic leg prototype aimed at increasing lateral balance control in prosthetic walking.

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON24065
Enrollment
30
Registered
2015-08-12
Start date
2015-10-01
Completion date
Unknown
Last updated
2024-06-11

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

Conditions

above knee amputation

Interventions

A reference group will perform the measurements unimpaired, without a prosthesis. A kneewalker group, consisting of healthy subjects, will perform the measurements with a Kneewalker. An amputee group

Sponsors

1) Department of Rehabilitation Medicine, UMCG 2) SPRINT
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: All subjects must be able to understand and follow spoken instructions in order to be included. Further, subjects must meet all of the following criteria: Amputee subjects: - Unilateral transfemoral amputation; - Between 18 – 80 years old; - Prosthetic rehabilitation period is completed; - Daily prosthetic use for at least one year; - K-level of mobility of at least 3; - Ability to walk independently for an hour, e.g. without the use of walking aids; - Space between prosthetic knee and floor at least 35cm. Able-bodied reference subjects: - x Kneewalker subjects: - Lower leg height of at least 50cm 3.

Exclusion criteria

Exclusion criteria: A potential subject who meets any of the following self reported criteria will be excluded from participation in this study: -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.

Design outcomes

Primary

MeasureTime frame
This is a pilot study. Therefore, no main outcome parameters can be specified. The goal of this study is however to validate a new prototype prosthetic device in terms of lateral balance control improvements. Therefore, our focus will be on finding improvements in lateral balance control of subjects wearing the prototype.

Contacts

Public ContactE.S. van Hal

A. Deusinglaan 1

e.s.van.hal@umcg.nl050 363 8902

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)