Effect of a training regime featuring the I-Travle system on arm function and skill performance in chronic stroke patients: a single arm trial.

Completed

• Conditions: obstruction of a bloodvessel or bleeding in the brain; stroke; 10007963

• Registration Number: NL-OMON38961
• Lead Sponsor: Adelante Kenniscentrum

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 29 April 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 10

Inclusion Criteria

o Age ><= 18 years;
o Clinically diagnosed with a central paresis of the arm/hand at entry in the study, caused by a supratentorial stroke;
o Post-stroke time more than 6 months;
o Having completed their active clinical rehabilitation program
o Hemiparesis featuring a low to moderate proximal (shoulder and arm) muscle strength:
* Motricity Index shoulder/arm item: minimum score of 14 and maximum 25 (out of 33), corresponding to a maximum active shoulder abduction of up to 90 degrees without resistance;
and/or
* a minimum active shoulder anteflexion of 30 degrees and a maximum active range of motion of 120 degrees shoulder joint anteflexion which can actively be maintained for 10 seconds;
o a fair cognitive level, i.e. being able to understand the questionnaires and measurement instructions;
o ability to read and understand Dutch.

Exclusion Criteria

o Severe spasticity of the arm, i.e. Modified Ashworth Scale (MAS) score for the elbow and wrist flexors: each * 3;
o Severe visual impairment and/or severe cognitive impairment which may interfere with the execution of the arm-hand tasks or the measurements;
o Severe neglect in the near extra personal space, established by the letter cancellation test and Bell*s test (quantitative evaluation) with a minimum omission score of 15%;
o Broca aphasia, Wernicke aphasia, global aphasia: as determined by the Akense Afasie Test (AAT);
o Severe apraxia as measured by the apraxia test of van Heugten;
o no informed consent.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Wolf Motor Function Test,<br /><br>ABILHAND,<br /><br>Goal Attainment Scaling. </p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Motricity index,<br /><br>plate tapping task,<br /><br>active range of motion,<br /><br>perceived strength,<br /><br>perceived fatigue.</p><br>