NCT05007002

Brief Summary

After a stroke, more than two out of three patients experience problems with upper limb movement and sensation. Current evidence on treatment of upper limb sensory impairments is scarce and shows unclear results. Robot-based therapy has been increasingly used to treat upper limb motor impairments, with similar positive results as compared to conventional therapy. This study aims to investigate a novel robot-based therapy program for treatment of upper limb sensory impairments. The therapy program consists of 10 one-hour session spread over 4 weeks and will be evaluated for its effect in 20 chronic stroke patients. The investigators hypothesize that a 4-week robot-based therapy program can improve upper limb sensation and movement.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
10

participants targeted

Target at below P25 for not_applicable stroke

Timeline
Completed

Started Jul 2021

Shorter than P25 for not_applicable stroke

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

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 11, 2021

Completed
3 days until next milestone

Study Start

First participant enrolled

July 14, 2021

Completed
1 month until next milestone

First Posted

Study publicly available on registry

August 16, 2021

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 13, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 13, 2022

Completed
Last Updated

July 20, 2022

Status Verified

July 1, 2022

Enrollment Period

11 months

First QC Date

July 11, 2021

Last Update Submit

July 19, 2022

Conditions

Stroke

Keywords

StrokeUpper limbSomatosensationSensory processingProprioceptionRobot-based therapyRobot-based assessment

Outcome Measures

Primary Outcomes (1)

  • Kinarm: sensory processing task

    Newly-developed task on the Kinarm End-Point Lab used to assess passive and active sensory processing

    Change during 4 weeks of therapy provided at least 6 months after stroke

Secondary Outcomes (15)

  • Kinarm: arm position matching task

    Change during 4 weeks of therapy provided at least 6 months after stroke

  • Kinarm: arm movement matching task

    Change during 4 weeks of therapy provided at least 6 months after stroke

  • Kinarm: visually guided reaching task

    Change during 4 weeks of therapy provided at least 6 months after stroke

  • Kinarm: working memory task

    Change during 4 weeks of therapy provided at least 6 months after stroke

  • Erasmus modified Nottingham sensory assessment

    Change during 4 weeks of therapy provided at least 6 months after stroke

  • +10 more secondary outcomes

Study Arms (1)

Robot-based therapy

EXPERIMENTAL

Chronic stroke patients receiving robot-based therapy

Device: Robot-based therapy

Interventions

Robot-based therapyDEVICE

Active and passive therapy tasks for proprioception and sensory processing, with use of the Kinarm End-Point Lab (BKIN Technologies Ltd., Canada)

Robot-based therapy

Eligibility Criteria

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

You may qualify if:

  • At least 18 years old
  • A first-ever unilateral, supratentorial stroke (as defined by WHO)
  • In the chronic phase after stroke (i.e. being at least 6 months after stroke)
  • Motor deficits of the upper limb (Fugl-Meyer Motor Assessment - Upper Extremity \< 60/66)
  • Somatosensory deficits of the upper limb (Erasmus modified Nottingham Sensory Assessment \< 36/40)
  • Ability to perform, at least to some extent, active shoulder abduction and wrist extension against gravity
  • Ability to perform passive and active sensory processing assessment task (primary outcome measure)

You may not qualify if:

  • History of previous stroke or TIA
  • Any serious musculoskeletal and/or other neurological conditions
  • Serious communication or cognitive deficits
  • No written informed consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

KU Leuven

Leuven, 3001, Belgium

Location

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor Neurorehabilitation

Study Record Dates

First Submitted

July 11, 2021

First Posted

August 16, 2021

Study Start

July 14, 2021

Primary Completion

June 13, 2022

Study Completion

June 13, 2022

Last Updated

July 20, 2022

Record last verified: 2022-07

Locations

BE(1)