Influence of a wearable soft robotic glove on functional ability of the arm/hand in stroke patients

Completed

Conditions: cerebrovascular accident
stroke
10007963

Registration Number: NL-OMON43981

Lead Sponsor: Revalidatiecentrum Het Roessingh

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 15

Inclusion Criteria

* Patients should be clinically diagnosed with unilateral ischemic or hemorrhagic stroke
* Between 18-80 years of age
* Time since onset of disease is at least 6 months.
* Discharged from specific arm/hand therapy
* Absence of severe spasticity of the hand (*2 points on Ashworth Scale).
* Absence of severe contractures limiting passive range of motion.
* Absence of co-morbidities limiting functional use of the arms/hands.
* People should have at least 10 degrees of active flexion and extension of the fingers.
* Absence of wounds on their hands that can give a problem when using the glove.
* Sufficient cognitive status to understand two-step instructions.
* Having (corrected to) normal vision.
* Living at home.
* Provided written informed consent.

Exclusion Criteria

* People with severe sensory problems of the affected hand.
* People with severe acute pain of the affected hand.
* Participation in other studies that can affect functional performance of the arm and hand.
* People having insufficient knowledge of the Dutch language to understand the purpose or methods of the study.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The main study parameters are outcomes related to user acceptance (System<br /><br>Usability Scale) in the usability study and functional hand performance in ADL<br /><br>(Action Research Arm Test) in the effect study. </p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Secundary study parameters are related to user acceptance, perceived use,<br /><br>amount of use, changes in hand motor function and impact on quality of life. </p><br>