NCT03755076

Brief Summary

Significant difficulty in incorporating the weaker arm in daily activities after stroke is, in part, driven by difficulty in engaging both arms interactively in a coordinated manner. The current study aims to determine the nature of bimanual coordination deficits after stroke and takes initial steps to test a novel theory-driven approach to improve interactive bimanual coordination in patients with stroke. This project will advance stroke rehabilitation by identifying novel, scientifically-based strategies to improve the engagement of the weaker arm in coordinated and interactive bimanual actions of daily life, thus improving quality of life in individuals after stroke.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
79

participants targeted

Target at P75+ for early_phase_1 stroke

Timeline
Completed

Started Apr 2019

Longer than P75 for early_phase_1 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

October 25, 2018

Completed
1 month until next milestone

First Posted

Study publicly available on registry

November 27, 2018

Completed
5 months until next milestone

Study Start

First participant enrolled

April 19, 2019

Completed
4.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 3, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 3, 2024

Completed
1.6 years until next milestone

Results Posted

Study results publicly available

August 14, 2025

Completed
Last Updated

August 14, 2025

Status Verified

July 1, 2025

Enrollment Period

4.7 years

First QC Date

October 25, 2018

Results QC Date

January 27, 2025

Last Update Submit

July 28, 2025

Conditions

Outcome Measures

Primary Outcomes (2)

  • Maximum Cross-correlation Coefficient

    Cross-correlation between tangential velocity profiles of the two hands was used to index spatial and temporal coordination between hands. Cross-correlation measures similarities of two distinct time series as a function of the displacement of one relative to the other. Repeated correlations between the two hand velocity profiles were obtained as the velocity profile of one hand was successively lagged. The maximum cross correlation coefficient obtained gave a measure of similarity between the two profiles, indexing spatial coordination. The better the arms moved in space, the higher the score they got, called the cross-correlation coefficient (CCr). CCr values range from zero to 1; with values close to 1 means the arms were moving very well together.

    After 20 minutes of training under each perceptual cue condition

  • Between Hands Time-lag

    Temporal coordination is about how well both arms move at the same time. Temporal coordination was quantified as the time lag at which the peak cross-correlation coefficient was obtained via cross-correlation analysis. If one arm moves a little later than the other, there's a time delay (or time lag). Shorter the delay, the better the timing between the arms. If the delay is positive, it means the weaker or less-used arm is moving after the stronger one.

    After 20 minutes of training under each perceptual cue condition

Study Arms (2)

Neurotypical Control

EXPERIMENTAL

Neurotypical healthy age-matched controls.

Behavioral: Perceptual cuing

Stroke survivor

EXPERIMENTAL

Stroke survivors with mild-to-moderate motor impairments

Behavioral: Perceptual cuing

Interventions

Participants were provided four perceptual cues (or feedback) in a pseudorandom order: (a) indiscriminate, (b) Altered gain, (c) Coordination, (d) Dual: altered gain and coordination

Neurotypical ControlStroke survivor

Eligibility Criteria

Age21 Years - 80 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Clinical diagnosis of unilateral stroke
  • ability to reach along a diagonal direction at least 80% of their arm length while fully supported on a frictionless surface and trunk constrained.
  • Mini-mental scale score \> 26, OR s score of 4 or above on auditory verbal comprehension part of the Western Aphasia Battery to ensure intact comprehension and following commands.
  • (e) no evidence of hemispatial neglect tested by a line bisection test.

You may not qualify if:

  • bilateral stroke,
  • complete paralyses,
  • basal ganglia/cerebellar stroke,
  • pain or stiffness in upper extremity that will interfere with the task or inability to follow task instructions.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Moss Rehabilitation Research Institute

Elkins Park, Pennsylvania, 19027, United States

Location

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

Limitations and Caveats

The study included moving a virtual brick without any haptic feedback. The virtual object was used to ensure systematic manipulation of perceptual cues at this early phase of translational research. Thus future studies need to determine if these findings may be applicable in real-world tasks. We included individuals with mild-to-moderate impairments; thus, these findings may not apply to those with more severe motor and cognitive impairments.

Results Point of Contact

Title
Dr. Shailesh Kantak
Organization
Albert Einstein Healthcare Network

Study Officials

  • Shailesh S Kantak, PhD, PT

    Moss Rehabilitation Research Institute

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
early phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Model Details: Participants will perform bilateral arm movements in a virtual reality environment under different perceptual conditions to identify a condition that improves coordination between arms.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Institute Scientist

Study Record Dates

First Submitted

October 25, 2018

First Posted

November 27, 2018

Study Start

April 19, 2019

Primary Completion

January 3, 2024

Study Completion

January 3, 2024

Last Updated

August 14, 2025

Results First Posted

August 14, 2025

Record last verified: 2025-07

Data Sharing

IPD Sharing
Will not share

Locations