The Effect of Robot-Assisted Versus Standard Training on Motor Function Following Subacute Rehabilitation After Ischemic Stroke - a Randomised Controlled Trial Nested in a Prospective Cohort.

Status: Recruiting
Location: See all (2) locations...
Intervention Type: Other
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

The aim of this randomised controlled trial (RCT) nested in a prospective cohort, is to investigate the superior effect of late-phase robot-assisted versus standard training on motor function, physical function, fatigue, and quality of life in a moderately-to-severely impaired chronic stroke population following subacute rehabilitation. The main hypothesis of the study is: Robot-assisted training has a superior effect on motor function (Fugl-Meyer Lower Extremity Assessment; primary outcome), physical function, fatigue, and quality of life in moderately-to-severely impaired chronic stroke-affected individuals in comparison to standard training.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• Ischemic apoplexia.

• Chronic state (6-24 months post-stroke).

• Subacute rehabilitation terminated (subacute phase defined as until 6 months post-stroke).

• Moderately-severely impaired:

‣ Modified Rankin Scale Score 3-5.

⁃ Scandinavian Stroke Scale Leg Motor Function Score 0-4 and/or SSS gait function 0-9.

• Approved by referring doctor

Locations
Other Locations
Denmark
Rigshospitalet and Herlev Gentofte Hospital
NOT_YET_RECRUITING
Copenhagen
Odense University Hospital
RECRUITING
Odense
Contact Information
Primary
Jon Skovgaard Jensen, Ph.d.-student
jskovgaard@health.sdu.dk
+4530127595
Backup
Anders Holsgaard-Larsen, Professor
AHLarsen@health.sdu.dk
Time Frame
Start Date: 2024-05-01
Estimated Completion Date: 2027-02-01
Participants
Target number of participants: 40
Treatments
Experimental: Intervention
Training facilitated through body weight unloading robotic technology yielding a dynamic unloading force applied to the body centre of mass.
Active_comparator: Active Control
Training facilitated without the use of body weight unloading robotic technology, thereby only allowing manual assistance from physiotherapists.
Related Therapeutic Areas
Sponsors
Leads: Odense University Hospital
Collaborators: University of Southern Denmark, Stanford University, Herlev and Gentofte Hospital, Sygehus Lillebaelt, Danish Association of the Physically Disabled, Rigshospitalet, Denmark

This content was sourced from clinicaltrials.gov