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van CCT (UK)


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van CCT (UK)


Leg prosthesis to improve lateral balance


- candidate number22728
- NTR NumberNTR5360
- ISRCTNISRCTN no longer applicable
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR12-aug-2015
- Secondary IDsNL52945.042.15 METc UMCG
- Public TitleLeg prosthesis to improve lateral balance
- Scientific TitleValidation of a prosthetic leg prototype aimed at increasing lateral balance control in prosthetic walking.
- ACRONYM
- hypothesisRationale:
A prosthetic leg imposes limitations in the ability for amputee walkers to actively control lateral balance during standing and walking. This results in a higher risk of falling, and limits prosthetic walkers in their activities of daily living. A new prosthesis has been developed to supplement the residual balance control strategies that prosthetic walkers have at their disposal.

Objective:
The main objective of this project is to validate if a new patented prototype prosthetic leg improves lateral balance control in prosthetic walking. In order to validate the prototype, lateral balance control will be compared between prosthetic walkers, unimpaired subjects, and unimpaired subjects wearing a prosthetic simulator (Kneewalker). Unimpaired subjects are included in order to establish baseline values for lateral balance control, since these are currently unknown.
- Healt Condition(s) or Problem(s) studiedUpper leg amputation, Prothesis
- Inclusion criteriaAll 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 criteriaA 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.
- mec approval receivedno
- multicenter trialno
- randomisedno
- groupParallel
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 1-okt-2015
- planned closingdate1-okt-2016
- Target number of participants30
- InterventionsA 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 will perform the measurements with a prosthesis. This will provide us with three independent groups. All groups will perform different walking tasks. The prototype has one degree of freedom in the frontal plane. This sideways motion can be locked by means of a fixating pin. This simulates a classic set-up in which the part between foot and knee is a fixed tube. The intervention thus consists of a direct comparison between prosthetic set-ups by either locking the prototype or having a freely moving prototype. The kneewalker and amputee groups will perform all measurements once with the prototype locked, and once with the prototype unlocked. The reference group will perform all measurements once.
- Primary outcomeThis 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.
- Secondary outcomen.a.
- Timepointsn.a.
- Trial web site
- statusplanned
- CONTACT FOR PUBLIC QUERIES E.S. van Hal
- CONTACT for SCIENTIFIC QUERIES E.S. van Hal
- Sponsor/Initiator University Medical Center Groningen (UMCG), Department of Rehabilitation Medicine, SPRINT
- Funding
(Source(s) of Monetary or Material Support)
SNN
- Publications
- Brief summary
- Main changes (audit trail)
- RECORD12-aug-2015 - 25-aug-2015


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