Effects of robot-assisted treadmill training in combination with resistance exercise on locomotor performance and quality of life as well as cardiovascular and neuromuscular properties in patients after stroke and individuals with spinal cord injury.

Completed

• Conditions: dwarslaesie; cerebrovascular accident; spinal cord lesion; stroke; 10011305

• Registration Number: NL-OMON32398
• Lead Sponsor: Vrije Universiteit

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 13 May 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 120

Inclusion Criteria

CVA
- first ever stroke (ischaemic, hemorarghic)
- hemiparesis (at least lower limb)
- min. age: 18 yrs
SCI
- motor incomplete lesion (ASIA C, D)
- paraplegia (at least lower limb)
- min age: 18 yrs.
All patient must be incapable to walk unaided.

Exclusion Criteria

- medical complications such as unstable hypertension-
arrhythmias and unstable cardiovascular problems
- severe skeletal problems such as osteoarthritis of the lower limbs.
- severe cognitive and/or communicative problems, preventing ability to follow verbal instructions
- earlier neurological and/or psychiatric problems
- other problems that would limit the ability to perform the requested tasks
- contra-indications for electrical stimulation (unstable epilepsy, cancer, skin abnormalities, pacemaker).

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The time at the 10m walk test will be used as the primary outcome variable to<br /><br>assess walking performance. </p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Additional outcome variables for functional performance are time to perform<br /><br>*get-up-and-go* test; score at Berg Balance Scale; Functional Ambulation<br /><br>Categories-score; Rivermead Mobility Index; distance walked at 6-min Walk test.<br /><br>Scores at the questionnaires SS-QOL, RAND-36/SF-36 will be used for assessment<br /><br>of quality of life and scores at the SIP68 will be used for assessment of<br /><br>social participation.<br /><br>Variables for cardiovascular function are maximal power output, VO2 and heart<br /><br>rate during a graded exercise test.<br /><br>Variables of lower limb muscle function include strength and rate of torque<br /><br>development during maximal voluntary contractions and (submaximal) electrically<br /><br>evoked contractions and fatigue resistance will be assessed with repeated<br /><br>electrically evoked contractions.</p><br>