Digital Technology-Informed Stroke Rehabilitation | NCT07698522

Studies
Digital Technology-Informed Stroke Rehabilitation

NCT07698522

Sponsor

University of Utah

Status

Not yet recruiting

Last Update Posted

Jul 13, 2026Actual

Enrollment

60Estimated

Phase

Not Applicable

Conditions

Stroke

Interventions

Lab-based movement guidance
Home-based movement guidance

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jul 2026

Overall Recruitment Status or Expanded Access Status

Not yet recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jul 2026Estimated

Primary Completion Date

Dec 2033Estimated

Completion Date

Dec 2033Estimated

First Submitted Date

Jul 6, 2026

First Submission Date that Met QC Criteria

Jul 6, 2026

First Posted Date

Jul 13, 2026Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 6, 2026

Last Update Posted Date

Jul 13, 2026Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

The goal of this study is to determine the effects of lab and home-based technology guidance during movement training post-stroke. The study will compare movement training informed by lab-based technology to training delivered with technology at home. The main questions it aims to answer are:

How well do lab and home-based technologies help individuals post-stroke improve their movement patterns?
Is there a difference in improvement between the in-lab and at-home training groups?
Which technologies lead to the most improvement?

Detailed Description

The study is a randomized, controlled feasibility trial investigating rehabilitation to improve movement patterns after stroke. The study will recruit participants who have had a stroke that led to upper-extremity impairment. Individuals will be assigned to one of two digital technology-guided groups. One group will be guided through exercises in a home-based setting, the other will be lab-based.

Participants will engage in training sessions multiple days a week for up to 6 weeks, either in-lab or at home. Both groups will visit the lab weekly for movement assessments.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

60Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
At-Home Training	Experimental	Participants will train at-home.	Other: Home-based movement guidance
In-Lab Training	Experimental	Participants will train in the lab.	Other: Lab-based movement guidance

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Lab-based movement guidance	Other	Participants will receive computer-generated guidance on how to perform different activities of daily living efficiently. The guidance will be delivered using lab-based sensing and feedback technology.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Kinematic movement quality score	A score based on subject kinematics during a daily task (like reaching), comparing the subject's reaching kinematics to normative kinematics.	From enrollment to the end of treatment at 3 weeks.

Secondary Outcomes

Measure	Description	Time Frame
FMA-UE Score	Upper Extremity Fugl-Meyer Score	From enrollment to the end of treatment at 3 weeks.

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Age between 30-85 years.
Diagnosis of stroke.
Stroke onset of at least six months prior to the time of participation.
Fugl Meyer Upper Extremity between 30-50 (mild-moderate)
Cognitive skills to consent and actively participate, as indicated by scores of ≥ 24 on the Mini- Mental Status Examination
Able to visit lab up to 5x per week for 3 weeks

Exclusion Criteria:

Presence of severe aphasia preventing the ability to follow 1-step directions at least 80% of the time.
Excessive spasticity of the wrist, elbow, and shoulder, defined as a Modified Ashworth Score >2.
Diagnosis of neurological disorders other than stroke.
Orthopedic/musculoskeletal conditions (e.g., severe arthritis) affecting the upper extremity.
Currently or planning to become pregnant.
Participation in concurrent occupational therapy.
Unilateral neglect, defined as failure of the Line Bisection Task
Upper extremity pain >= 7/10 on Numeric Rating Scale

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

30 Years

Maximum Age

85 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Samantha McNeill	Contact	(385) 215-9146‬		samantha.mcneill@utah.edu

Overall Officials

Name	Affiliation	Role
Scott Uhlrich, PhD	University of Utah	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Kennecott Mechanical Engineering Building		Salt Lake City	Utah	84112	United States

IPD Sharing Statement Module

Plan to Share IPD

Yes

Description

We will share participant demographics and outcomes data. We will also share kinematics data. These data will be shared on SimTK.org.

Types

Analytic Code

Time Frame

Code and data will be shared upon publication.

Access Criteria

Code and data will be shared publicly on SimTK.org.

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D020521	Stroke

Ancestor Terms

ID	Term
D002561	Cerebrovascular Disorders
D001927	Brain Diseases
D002493	Central Nervous System Diseases
D009422	Nervous System Diseases

Browse Leaves

Not provided

Browse Branches

Not provided