Advantages of a flexible wrist unit compared to a static wrist unit in people using an arm prosthesis.

Completed

Conditions: amputatie zowel verworven als congenitaal
upper limb amputation
10028396

Registration Number: NL-OMON38501

Lead Sponsor: niversitair Medisch Centrum Groningen

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 16

Inclusion Criteria

Patients:
-Having at least one year experience with using a myo-electrical lower arm prosthesis with a passive wrist unit. People using an active, static wrist unit can join the project when not enough participants can be found who use a passive wrist unit.
-Wearing the prosthesis for at least four hours a day.
-The prosthetic hand has got one degree of freedom (opening and closing the hand).
-Able to undergo tests and to fill out questionnaires.
Participants only participate after providing written informed consent. ;Healthy participants:
- Matching one participant (prosthetic user) for hand dominance (prosthetic user*s dominant hand is concerned as the non-amputated hand), age, gender, length and weight.

Exclusion Criteria

Prosthetic users:
-Co morbidities that could influence the results of the study (for example, neurological disorders or rheumatic diseases that can influence arm function).
-Having experience with a Flex-wrist or Multi-flex wrist. ;Healthy subjects:
- Having any complaints of the musculoskeletal system.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>This study assesses the value and added value of a wrist unit that can be put<br /><br>in a flexion position and a wrist unit that can not only be put in a flexion<br /><br>position but can also move freely in a neutral position compared to a rigid<br /><br>wrist unit.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>- Expectations about functionality of the new prosthetic wrist, compared to own<br /><br>prosthesis.<br /><br>- Joint angles (compensatory movements) during execution of several ADL<br /><br>(activities of daily living) tasks.<br /><br>- Pressure inside the socket of the prosthesis.<br /><br>- Functionality during usage of the prosthesis.<br /><br>- Satisfaction of the user and information about benefits/disadvantages. </p><br>