NCT04818073

Brief Summary

The investigators would like to investigate the effectiveness of somatosensory training for robot-assisted hand motor rehabilitation after stroke.

Trial Health

55
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started May 2022

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
active not recruiting

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

March 23, 2021

Completed
3 days until next milestone

First Posted

Study publicly available on registry

March 26, 2021

Completed
1.1 years until next milestone

Study Start

First participant enrolled

May 6, 2022

Completed
3.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 31, 2025

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 31, 2025

Completed
Last Updated

October 15, 2024

Status Verified

October 1, 2024

Enrollment Period

3.1 years

First QC Date

March 23, 2021

Last Update Submit

October 8, 2024

Conditions

Stroke, IschemicCerebrovascular Accident (CVA)

Keywords

Rehabilitation

Outcome Measures

Primary Outcomes (1)

  • Box and Blocks Test

    We compare the change of Box and Block Test scores from baseline evaluation to 1-month post intervention. Participants are instructed to move as many blocks as possible, one at a time, from one compartment in a box to a second compartment over a divider for a period of 60 seconds; each block that is moved is counted, and multiple blocks moved at the same time are counted as a single block. The higher scores indicate a better outcome.

    From baseline to 1-month post intervention

Secondary Outcomes (3)

  • Fugl-Meyer Motor Assessment of the Upper Extremity

    From baseline to 1-month post intervention

  • Motor Activity Log

    From baseline to 1-month post intervention

  • Changes in finger proprioception measured using the Crisscross Assessment.

    From baseline to 1-month post intervention

Study Arms (3)

Group A

EXPERIMENTAL

Participants with undergo new FINGER robotic training with no physical assistance 3 times a week for a period of 3 weeks.

Device: New FINGER

Group B

EXPERIMENTAL

Participants will undergo new FINGER robotic training with physical assistance 3 times a week for a period of 3 weeks.

Device: New FINGER

Group C

EXPERIMENTAL

Participants will undergo new FINGER robotic training with physical assistance and proprioceptive exercises 3 times a week for a period of 3 weeks.

Device: New FINGER

Interventions

New FINGERDEVICE

New FINGER exoskeleton is a robotic device that can provide assistance and resistance to thumb and finger movement

Group AGroup BGroup C

Eligibility Criteria

Age18 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age 18 to 85 years
  • Suffered from a single ischemic stroke (radiologically confirmed) at least 6-months prior to enrollment
  • An ability to score at least 3 blocks on the Box and Block Test

You may not qualify if:

  • A substantial decrease in alertness, language reception or attention
  • Pregnant or lactating
  • Advanced liver, kidney, cardiac or pulmonary disease
  • Plan to alter any current participation in other rehabilitation therapy in the time period of the study
  • A terminal medical diagnosis consistent with survival \< 1 year
  • Coexistent major neurological disease
  • Coexistent major psychiatric disease
  • A history of significant alcohol or drug abuse in the prior 3 years
  • Current enrollment in another study related to stroke or stroke recovery
  • Any other medical contraindication to participation in this study evaluated by our team physician.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of California Irvine

Irvine, California, 92697, United States

Location

Related Publications (2)

  • Rowe JB, Chan V, Ingemanson ML, Cramer SC, Wolbrecht ET, Reinkensmeyer DJ. Robotic Assistance for Training Finger Movement Using a Hebbian Model: A Randomized Controlled Trial. Neurorehabil Neural Repair. 2017 Aug;31(8):769-780. doi: 10.1177/1545968317721975.

    PMID: 28803535BACKGROUND

  • Ingemanson ML, Rowe JB, Chan V, Wolbrecht ET, Cramer SC, Reinkensmeyer DJ. Use of a robotic device to measure age-related decline in finger proprioception. Exp Brain Res. 2016 Jan;234(1):83-93. doi: 10.1007/s00221-015-4440-4. Epub 2015 Sep 16.

    PMID: 26378004BACKGROUND

MeSH Terms

Conditions

Ischemic StrokeStroke

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

Study Officials

  • David Reinkensmeyer, Ph.D

    University of California, Irvine

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
Randomized single-blinded
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

March 23, 2021

First Posted

March 26, 2021

Study Start

May 6, 2022

Primary Completion

May 31, 2025

Study Completion

August 31, 2025

Last Updated

October 15, 2024

Record last verified: 2024-10

Data Sharing

IPD Sharing
Will not share

Locations

US(1)