NCT07156955

Brief Summary

The investigators aim to develop sensory transformation and augmentation technologies that minimize the impact of proprioceptive errors, thereby significantly enhancing motor learning and rehabilitation of the upper limbs. This study is designed to test proprioceptive error compensation techniques in stroke patients. The human nervous system often receives mismatched information from vision and proprioception during upper limb control, resulting in conflicting sensory inputs that limit the effectiveness of motor learning. In other words, real-time sensory feedback - a critical component of motor learning in the nervous system - is not reliably delivered. Therefore, this study seeks to resolve sensory conflicts by providing additional sensory information through electrical stimulation, with the goal of dramatically improving the effectiveness of motor learning.

Trial Health

77
On Track

Trial Health Score

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

Enrollment
3

participants targeted

Target at below P25 for not_applicable

Timeline
4mo left

Started Oct 2025

Geographic Reach
1 country

1 active site

Status
recruiting

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

Study Progress64%
Oct 2025Aug 2026

First Submitted

Initial submission to the registry

August 11, 2025

Completed
25 days until next milestone

First Posted

Study publicly available on registry

September 5, 2025

Completed
1 month until next milestone

Study Start

First participant enrolled

October 13, 2025

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2025

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 30, 2026

Expected
Last Updated

October 6, 2025

Status Verified

August 1, 2025

Enrollment Period

3 months

First QC Date

August 11, 2025

Last Update Submit

September 30, 2025

Conditions

Outcome Measures

Primary Outcomes (1)

  • Improvement in upper limb motor function

    Upper limb motor function will be evaluated using standardized clinical scales such as the Fugl-Meyer Assessment and proprioceptive accuracy tests. 0 indicates severe movement limitation, while a score of 66 reflects normal motor function of upper limb. Participants will undergo evaluations and treatment during six visits over approximately three weeks.

    6 visits over 3 weeks

Secondary Outcomes (1)

  • Proprioceptive accuracy

    Baseline before intervention and immediately after the 30-minute training session

Study Arms (6)

Electrical stimulation cue first

EXPERIMENTAL

Patients undergo three types of interventions, following one of two processes. Each process has its own protocol in the following order Electrical stimulation cue, Visual cue, and No cue or Electrical stimulation cue, No cue, and Visual cue.

Behavioral: Electrical stimulation cueBehavioral: Visual stimulation cueBehavioral: No cue

Visual stimulation cue first

EXPERIMENTAL

Patients undergo three types of interventions, following one of two processes. Each process has its own protocol in the following order: Visual cue, Electrical stimulation cue, and No cue, or Visual cue, No cue, and Electrical stimulation cue.

Behavioral: Electrical stimulation cueBehavioral: Visual stimulation cueBehavioral: No cue

No cue first

EXPERIMENTAL

Patients undergo three types of interventions, following one of two processes. Each process has its own protocol in the following order: No cue, Electrical stimulation cue, and Visual cue, or No cue, Visual cue, and Electrical stimulation cue.

Behavioral: Electrical stimulation cueBehavioral: Visual stimulation cueBehavioral: No cue

Only electrical stimulation cue

EXPERIMENTAL

Patients undergo one types of interventions which is the Electrical stimulation cue.

Behavioral: Electrical stimulation cue

Only visual stimulation cue

EXPERIMENTAL

Patients undergo one types of interventions which is the Visual stimulation cue.

Behavioral: No cue

Only no cue

EXPERIMENTAL

Patients undergo one types of interventions which is the No cue.

Behavioral: Visual stimulation cue

Interventions

A single 30-minute session is provided. Electrodes are attached to the cubital fossa, and stimulation is delivered at a frequency that increases up to 70 Hz as the elbow joint approaches the target angle. Target angles are set between 0 degrees and 120 degrees, based on each participant's available range of motion determined during the initial assessment. Participants adjust their elbow joint angle to match the provided target angle using feedback from the electrical stimulation. When the elbow joint angle matches the target angle, the maximum frequency is applied to the cubital fossa. Participants match their elbow joint angle to the target angle based on the given frequency.

Electrical stimulation cue firstNo cue firstOnly electrical stimulation cueVisual stimulation cue first

A single 30-minute session is provided. The difference between the current elbow joint angle and the pre-set target angle is displayed on a screen using two colored needles (a red needle for the target angle and a black needle for the current elbow joint angle). The target angle is set within each participant's available range of motion based on the initial assessment. Participants continue the intervention by adjusting their elbow angle using the visual feedback. When the elbow joint angle matches the target angle, the two needles overlap. Based on this visual cue, participants adjust their elbow joint angle to match the target angle.

Electrical stimulation cue firstNo cue firstOnly no cueVisual stimulation cue first
No cueBEHAVIORAL

A single 30-minute session is provided. The target angle is determined within each participant's available range of motion based on the initial assessment. Throughout the session, participants receive verbal feedback from the assessor and adjust their elbow joint angle accordingly to match the target angle.

Electrical stimulation cue firstNo cue firstOnly visual stimulation cueVisual stimulation cue first

Eligibility Criteria

Age19 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Diagnosed with ischemic or hemorrhagic stroke
  • Stroke confirmed by CT or MRI
  • Stroke patients with proprioceptive sensory deficits
  • Chronic stroke patients with onset at least 3 months prior
  • Able to voluntarily flex and extend the elbow joint
  • Age 19 years or older
  • Provide written informed consent (participant or legal representative)

You may not qualify if:

  • Severe pain during elbow joint movement
  • Elbow joint contracture, spasticity, ataxia, musculoskeletal disorders, fractures, - non-healing ulcers, or open wounds
  • Progressive or unstable stroke
  • Presence of unilateral neglect
  • Coexisting severe neurological disorders
  • Major psychiatric disorders such as major depressive disorder, schizophrenia, bipolar disorder, or dementia Presence of a pacemaker

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Shinchon Severance Rehabilitation Hospital

Seoul, Seoul, 03722, South Korea

RECRUITING

MeSH Terms

Conditions

Ischemic Stroke

Condition Hierarchy (Ancestors)

StrokeCerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

Central Study Contacts

June Seung Lee, Graduate student

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate professor

Study Record Dates

First Submitted

August 11, 2025

First Posted

September 5, 2025

Study Start

October 13, 2025

Primary Completion

December 31, 2025

Study Completion (Estimated)

August 30, 2026

Last Updated

October 6, 2025

Record last verified: 2025-08

Data Sharing

IPD Sharing
Will not share

Locations