NCT05421910

Brief Summary

Robotic training can be used to provide intensive training during the (early phases of) rehabilitation of a stroke. ROBERT®-SAS training is designed to create an active and intensive training tool for the rehabilitation of the lower extremity of stroke patients. Currently this has only be tested in a lab-based setting, which showed that is was feasible and could be executed while still being comfortable for the patient. The next step will be implementing the device in a clinical setting. Therefore, aims the current study to assess the feasibility of ROBERT®-SAS training in clinical setting, in acute stroke patients.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
9

participants targeted

Target at below P25 for not_applicable stroke

Timeline
Completed

Started Jul 2022

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 9, 2022

Completed
7 days until next milestone

First Posted

Study publicly available on registry

June 16, 2022

Completed
25 days until next milestone

Study Start

First participant enrolled

July 11, 2022

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 24, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 24, 2023

Completed
Last Updated

September 18, 2023

Status Verified

September 1, 2023

Enrollment Period

1.1 years

First QC Date

June 9, 2022

Last Update Submit

September 15, 2023

Conditions

Stroke

Keywords

RoboticElectrical stimulationLower extremityStroke

Outcome Measures

Primary Outcomes (1)

  • System Usability Scale (SUS) score

    The System Usability Scale of patients and therapists. 10 questions with a 5-point response scale. The total score can range from 0 - 100, in which a higher score indicates a better usability

    15 minutes

Secondary Outcomes (13)

  • Electromyography (EMG)

    30 minutes

  • Force

    30 minutes

  • Frequency

    30 minutes

  • Assist-As-Needed (AAN) stages

    30 minutes

  • Fugl-Meyer Assessment (FMA)

    10 minutes

  • +8 more secondary outcomes

Other Outcomes (6)

  • Gender

    1 minutes

  • Age

    1 minutes

  • Time since stroke

    1 minutes

  • +3 more other outcomes

Study Arms (2)

Early training group

EXPERIMENTAL

The early group will receive robotic training combined with electrical stimulation as soon as possible after submission to the rehab center. With a frequency of three times a week for 3-5 weeks, dependent on the capabilities of the patients.

Device: robotic training combined with electrical stimulation

Late training group

ACTIVE COMPARATOR

The late training group will receive robotic training combined with electrical stimulation 3-5 weeks after submission to the rehab center. With a frequency of three times a week for 3-5 weeks, dependent on the capabilities of the patients.

Device: robotic training combined with electrical stimulation

Interventions

robotic training combined with electrical stimulationDEVICE

Active training of movements in supine position. Movements such as knee extension and ankle dorsal flexion.

Early training groupLate training group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Sub(acute) stroke (\< 6 months post-stroke)
  • Above 18 years
  • Able to provide informed consent
  • An ischemic or haemorrhagic stroke
  • Hemiparetic lower extremity

You may not qualify if:

  • Premorbid disability of lower extremity
  • Severe cognitive impairment, unable to follow simple instructions and unable to understand Dutch.
  • Skin lesions at the hemiparetic leg
  • Progressive neurological diseases (i.e. Parkinson, dementia, etc.)
  • Contraindication for mobilization like unhealed lower limb fracture
  • Use of pacemaker

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Roessingh Research and Development

Enschede, Overijssel, 7522AH, Netherlands

Location

MeSH Terms

Conditions

Stroke

Interventions

Electric Stimulation

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

Physical StimulationInvestigative Techniques

Study Officials

  • Gerdienke Prange, PhD

    Roessingh Research and Development

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
DEVICE FEASIBILITY
Intervention Model
CROSSOVER
Model Details: One group will receive robotic training as soon as possible, another group will receive robotic training 3-5 weeks, after submission to the rehab center. Normal rehabilitation will also carry on.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 9, 2022

First Posted

June 16, 2022

Study Start

July 11, 2022

Primary Completion

August 24, 2023

Study Completion

August 24, 2023

Last Updated

September 18, 2023

Record last verified: 2023-09

Data Sharing

IPD Sharing
Will not share

Locations

NL(1)