Bimanual Motor Skill Learning Through Robotics in Stroke Survivors and Healthy Individuals

Stroke Clinical Trial

— bimMsKL  

Official title:

Bimanual Motor Skill Learning Through Robotics in Stroke Survivors and Healthy Individuals

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03974750
• Other study ID #: bimMsKL
• Status: Recruiting
• Phase: N/A
• Start date: July 1, 2017
• Est. completion date: December 31, 2027

Study information

• Verified date: January 2024
• Source: University Hospital of Mont-Godinne
• Contact: Yves Vandermeeren, MD, PhD
• Phone: +3281423321
• Email: yves.vandermeeren[@]uclouvain.be
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

To test the capacity of healthy and chronic stroke patients to learn and retain a complex bimanual motor skill, trained on the neurorehabilitation robot REAplan (R) (bimanual version).

Description:

Over 3 consecutive days, healthy individuals and chronic stroke patients (1) will be evaluated and (2) will train on the neurorehabilitation robot REAplan(R).

They will practice several tasks on the robot REAplan (R) (bimanual version), requiring either movements with the affected arm (unimanual tasks) and complex, coordinated movements with both arms (bimanual tasks).

In addition, several "classical" clinical scales and tests will be used to evaluate overall motor-sensory-cognitive functions (clinical tests, questionnaires, ...).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: December 31, 2027
• Est. primary completion date: December 31, 2027
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

STROKE PATIENTS :

Inclusion Criteria:

• having a chronic stroke (>6 months)

• aged 18-90 years

• with demonstrate a stroke lesion on brain imaging.

Exclusion Criteria:

• difficulty in understanding or executing commands

• drug/alcohol abuse

• severe aphasia / cognitive deficits interfering with study

• inability to voluntarily move the affected arm (i.e. complete paralysis of the arm)

• multiple strokes / dementia / psychiatric condition

• botulinum toxin injections (to be evaluated)

HEALTHY INDIVIDUALS :

Inclusion Criteria:

• 18-90 years

Exclusion Criteria:

• neurological conditions interfering with the study

• drug/alcohol abuse

• pyschiatric condition

Related Conditions & MeSH terms

• Stroke

Intervention

Device:
• Bimanual motor skill learning with the REAplan(R) rehabilitation robot
REAplan(R) rehabilitation robot : training to perform complex, coordinated, bimanual movements

Locations

Country	Name	City	State
Belgium	CHU UCL Namur, Mont-Godinne, Neurology Department, Stroke Unit	Yvoir	Namur
Belgium	Department of Neurology, CHU Mont-Godinne	Yvoir	Namur

Sponsors (2)

Lead Sponsor	Collaborator
University Hospital of Mont-Godinne	Université Catholique de Louvain

Country where clinical trial is conducted

Belgium, 

References & Publications (3)

Dehem S, Gilliaux M, Lejeune T, Delaunois E, Mbonda P, Vandermeeren Y, Detrembleur C, Stoquart G. Effectiveness of a single session of dual-transcranial direct current stimulation in combination with upper limb robotic-assisted rehabilitation in chronic stroke patients: a randomized, double-blind, cross-over study. Int J Rehabil Res. 2018 Jun;41(2):138-145. doi: 10.1097/MRR.0000000000000274. — View Citation

Doost MY, Orban de Xivry JJ, Herman B, Vanthournhout L, Riga A, Bihin B, Jamart J, Laloux P, Raymackers JM, Vandermeeren Y. Learning a Bimanual Cooperative Skill in Chronic Stroke Under Noninvasive Brain Stimulation: A Randomized Controlled Trial. Neurorehabil Neural Repair. 2019 Jun;33(6):486-498. doi: 10.1177/1545968319847963. Epub 2019 May 15. — View Citation

Yeganeh Doost M, Orban de Xivry JJ, Bihin B, Vandermeeren Y. Two Processes in Early Bimanual Motor Skill Learning. Front Hum Neurosci. 2017 Dec 20;11:618. doi: 10.3389/fnhum.2017.00618. eCollection 2017. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	bi-SAT, bimanual Speed/Accurady Trade-off measured by the REAplan robot	bimanual Speed/Accurady Trade-off: mathematical computation of the relationship bewteen speed and accuracy	change between baseline (Day 1) and after training (Day 3)
Primary	bi-CO, bimanual Coordination factor measured by the REAplan robot	bimanual Coordination factor, mathematical measure of the phase coherence between speeds of both arms	change between baseline (Day 1) and after training (Day 3)
Primary	bi-Force, bimanual Coordination factor measured by the REAplan robot	bimanual forces, forces exerted in the wrong direction by each arm (Newtons)	change between baseline (Day 1) and after training (Day 3)
Secondary	bi-SAT on bimanual REACHING (REAplan robot)	bimanual Speed/Accurady Trade-off: mathematical computation of the relationship	change between baseline (Day 1) and after training (Day 3)
Secondary	bi-Force on bimanual REACHING (REAplan robot)	bimanual forces, forces exerted in the wrong direction by each arm (Newtons)	change between baseline (Day 1) and after training (Day 3)
Secondary	bi-CO on bimanual REACHING (REAplan robot)	bimanual Coordination factor, mathematical measure of the phase coherence between speeds of both arms	change between baseline (Day 1) and after training (Day 3)
Secondary	bi-smoothness on bimanual REACHING (REAplan robot)	Smoothness of movement : Spectral Arc Length (SPARC)	change between baseline (Day 1) and after training (Day 3)
Secondary	bi-error on bimanual REACHING (REAplan robot)	Error in centimeres or degrees during bimanual reaching	change between baseline (Day 1) and after training (Day 3)
Secondary	BBT	Box & Blocks Test (timed transfert of blocks from one space to the other, 3 trials/hand)	change between baseline (Day 1) and after training (Day 3)
Secondary	whole-hand GF	whole-hand Grip Force (GF) measured with a dynamometer, 3 trials/hand)	change between baseline (Day 1) and after training (Day 3)
Secondary	Visual Analog Scale for fatigue (VAS fatigue)	Visual Analog Scale to evaluate fatigue = a psychometric response scale which can be used in questionnaires. It is a measurement instrument for subjective characteristics or attitudes that cannot be directly measured. When responding to a VAS item, respondents specify their level of agreement to a statement by indicating a position along a continuous line between two end-points. Range : 0- 10.	change between baseline (Day 1) and after training (Day 3)