Robot-Assisted Training Versus Standard Training in Ischemic Stroke

NCT06273475 | Recruiting

• 1 other identifier: OUH RoboRehab
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

Stroke; Ischemic Stroke

Keywords

Stroke; Body weight unloading; Motor function; Rehabilitation

Outcome Measures

Primary Outcomes (1)

• Fugl-Meyer Lower Extremity Assessment of Motor Function

  The primary outcome measure is the between-group difference in change score of Fugl-Meyer Lower Extremity Assessment (FM-LE) from pre- (T6) to post-intervention (T12). The FM-LE assesses motor function and has been recommended as a part of a core outcome set in stroke rehabilitation studies.

  Pre-intervention (6-18 months post-stroke) and post-intervention (12-24 months post-stroke).

Secondary Outcomes (10)

• Modified Rankin Scale Score (between-group change)

  Prospective cohorte: 3, 6, 12, and 18 months post stroke. RCT: Pre-intervention (6-18 months post-stroke) and post-intervention (12-24 months post-stroke) and follow-up (18-30 months post-stroke).

• Functional Ambulation Category (between-group change)

  RCT: Pre-intervention (6-18 months post-stroke) and post-intervention (12-24 months post-stroke).

• Berg Balance Scale (between-group change)

  RCT: Pre-intervention (6-18 months post-stroke) and post-intervention (12-24 months post-stroke).

• Barthel-100 Index (between-group change)

  RCT: Pre-intervention (6-18 months post-stroke) and post-intervention (12-24 months post-stroke).

• Global Rating of Change (between-group change)

  RCT: Post-intervention (12-24 months post-stroke) and follow-up (18-30 months post-stroke)

Other Outcomes (9)

• Muscle Strength (between-group change)

  RCT: Pre-intervention (6-18 months post-stroke) and post-intervention (12-24 months post-stroke).

• Modified Sit-to-Stand Test (between-group change)

  RCT: Pre-intervention (6-18 months post-stroke) and post-intervention (12-24 months post-stroke).

• Blood Biomarkers (between-group change)

  Cohorte: 3 months post-stroke. RCT: Pre-intervention (6-18 months post-stroke) and post-intervention (12-24 months post-stroke).

Study Arms (2)

Intervention

EXPERIMENTAL

Training facilitated through body weight unloading robotic technology yielding a dynamic unloading force applied to the body centre of mass.

Other: Robot-assisted Training

Active Control

ACTIVE COMPARATOR

Training facilitated without the use of body weight unloading robotic technology, thereby only allowing manual assistance from physiotherapists.

Other: Standard Training

Interventions

Robot-assisted Training OTHER

Gait training and functional strength training facilitated by body weight unloading robotic technology yielding a dynamic unloading force applied to the body centre of mass. Gait training will be conducted both on treadmill and overground. Functional strength training exercises include sit-to-stand, stair-walking, step-ups etc. The goal is to gradually reduce body weight unloading as participants progress through the intervention period.

Intervention

Standard Training OTHER

Gait training and functional strength training facilitated without the use of body weight unloading robotic technology, thereby only allowing manual assistance from physiotherapists. The goal of training is the same as in the intervention group, however no body weight unloading device will be implemented in the active control group.

Active Control

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Ischemic and haemorrhagic stroke
• 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

You may not qualify if:

• Prior SAH
• Infarct located in the cerebellum or brain stem
• Severe fatigue making study completion improbable.
• Cognitive deficits impeding study participation.
• Inability to walk independently pre-stroke.
• Recurrence of cardiovascular/cerebrovascular accidents.
• Pre-existing neurological diseases or ongoing cancer treatment.
• Refusing group allocation.
• Concurrent participation in another clinical trial potentially interacting with the present trial.

Sponsors & Collaborators

• Odense University Hospital: lead
• University of Southern Denmark: collaborator
• Rigshospitalet, Denmark: collaborator
• Herlev and Gentofte Hospital: collaborator
• Stanford University: collaborator
• Sygehus Lillebaelt: collaborator
• Danish Association of the Physically Disabled: collaborator

Study Sites (2)

Rigshospitalet and Herlev Gentofte Hospital

Copenhagen, Denmark

NOT YET RECRUITING

Odense University Hospital

Odense, Denmark

RECRUITING

Related Publications (1)

• Skovgaard Jensen J, Sorensen AS, Kruuse C, Nielsen HH, Skov CD, Jensen HB, Buckwalter MS, Bojsen-Moller J, Lambertsen KL, Holsgaard-Larsen A. The effect of robot-assisted versus standard training on motor function following subacute rehabilitation after ischemic stroke - protocol for a randomised controlled trial nested in a prospective cohort (RoboRehab). BMC Neurol. 2024 Jul 4;24(1):233. doi: 10.1186/s12883-024-03734-9.

  PMID: 38965499 DERIVED

MeSH Terms

Conditions

Stroke; Ischemic Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Jon Skovgaard Jensen, Ph.d.-student

  Department of Clinical Research, University of Southern Denmark

  PRINCIPAL INVESTIGATOR

• Anders Holsgaard-Larsen, Professor

  Odense University Hospital and Department of Clinical Research, University of Southern Denmark

  STUDY DIRECTOR

Central Study Contacts

Jon Skovgaard Jensen, Ph.d.-student

CONTACT

+4530127595; jskovgaard@health.sdu.dk

Anders Holsgaard-Larsen, Professor

CONTACT

AHLarsen@health.sdu.dk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Data will be analysed by the PhD student blinded towards group allocation. The test leader responsible for RCT outcome assessment will be blinded towards group allocation.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Multicentre randomised (1:1) parallel-group intervention study with assessor-blinding.

Study Record Dates

• First Submitted: February 1, 2024
• First Posted: February 22, 2024
• Study Start: May 1, 2024
• Primary Completion: March 1, 2026
• Study Completion (Estimated): February 1, 2027
• Last Updated: November 20, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

DK (2)