NCT07806097

Brief Summary

STRIVE uses a camera mounted on the in-room TV and a connected laptop to track arm and hand movements during gameplay via markerless motion capture. No controllers or wearable sensors are required, and patients initiate a session with a single button on the TV remote. Games target clinically relevant movements such as reaching and grasping, with difficulty adapting to the user.

Trial Health

77
On Track

Trial Health Score

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

Enrollment
30

participants targeted

Target at P25-P50 for not_applicable stroke

Timeline
14mo left

Started Jul 2026

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress15%
Jul 2026Dec 2027

Study Start

First participant enrolled

July 20, 2026

Completed
1 day until next milestone

First Submitted

Initial submission to the registry

July 21, 2026

Completed
2 months until next milestone

First Posted

Study publicly available on registry

September 8, 2026

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 20, 2027

Expected
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 20, 2027

Last Updated

September 8, 2026

Status Verified

September 1, 2026

Enrollment Period

1 year

First QC Date

July 21, 2026

Last Update Submit

September 1, 2026

Conditions

Keywords

gamingupper extremityoccupational therapydosagereps

Outcome Measures

Primary Outcomes (6)

  • Observational Notes

    Taken by study staff during session. Notes are entered into structured template.

    During every session throughout phase 1 (months 3-4) --and during at least 2 sessions for every participant during phase 4 (months 15-18)

  • Adherence Notes

    Study staff record days of attempted use and reasons for missed days, when available.

    Throughout all sessions during phase 4 (months 15-18)

  • System Usability Scale (SUS)

    10-item assessment, each item rated on a 5-point Likert scale. Items are scored to yield a total score from 0 to 100, with higher scores indicating better perceived usability.

    All sessions of phase 1 (months 3-4) and final sessions of each participant in phase 4 (months 15-18)-- completed at session conclusion following STRIVE engagement.

  • Quebec User Evaluation of Satisfaction with Assistive Technology (QUEST)

    Participants are asked to rate their satisfaction for STRIVE on a 5 point scale that ranges from "not satisfied" at all to "very satisfied." Quest has 12 items, with higher scores reflecting higher user satisfaction.

    All sessions of phase 1 (months 3-4) and final sessions of each participant in phase 4 (months 15-18)-- administered at session conclusion following STRIVE engagement.

  • STRIVE system logs

    STRIVE will automatically record data that includes session start/end time, duration, active play time, number of sessions completed, and performance metrics.

    Throughout phase 1 (months 3-4) and phase 4 (months 15-18)

  • Total time of Engagement for Strive

    STRIVE will automatically record data that includes session start/end time. Duration will be calculated via END\_TIME-START\_TIME.

    Every session during phase 1 (months 3-4) and phase 4 (months 15-18)

Secondary Outcomes (6)

  • Rates and incidents

    All sessions of each participant in phase 4 (months 15-18)

  • Intrinsic Motivation Inventory (IMI)- short form

    All sessions of phase 1 (months 3-4) and final sessions of each participant in phase 4 (months 15-18)-- administered at session conclusion following STRIVE engagement.

  • Pittsburgh Rehabilitation Participation Scale (PRPS)

    All sessions of phase 1 (months 3-4) and at least 2 sessions for each participant in phase 4 (months 15-18)-- administered at session conclusion following STRIVE engagement.

  • Number of STRIVE Sessions Completed

    Every session in phase 4 (months 15-18)

  • Participant-Rated Acceptability of the STRIVE System

    All sessions of phase 1 (months 3-4) and final sessions of each participant in phase 4 (months 15-18)-- administered at session conclusion following STRIVE engagement.

  • +1 more secondary outcomes

Other Outcomes (1)

  • Participant movement smoothness

    Every session in phase 1 (months 3-4) and phase 4 (months 15-18)

Study Arms (1)

STRIVE participants

EXPERIMENTAL

Participants using STRIVE

Other: Self-Directed Therapeutic Rehab using In-room Virtual Entertainment (STRIVE)

Interventions

In-room upper extremity gaming system using markerless motion tracking

STRIVE participants

Eligibility Criteria

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

You may qualify if:

  • admitted for IP stroke rehabilitation ARAT \>5 and \<40 at enrollment
  • sufficient cognition and vision to follow simple instructions
  • medically stable for independent seated or supine UE activity

You may not qualify if:

  • severe neglect that prevents task engagement
  • significant aphasia that prevents understanding of instructions
  • medical contraindications to unsupervised UE activity as determined by the treating team

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Shirley Ryan AbilityLab

Chicago, Illinois, 60611-3167, United States

RECRUITING

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

Study Officials

  • Milap Sandhu

    Shirley Ryan AbilityLab

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Rachel A Kalvakota, OTD, OTR/L

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

July 21, 2026

First Posted

September 8, 2026

Study Start

July 20, 2026

Primary Completion (Estimated)

July 20, 2027

Study Completion (Estimated)

December 20, 2027

Last Updated

September 8, 2026

Record last verified: 2026-09

Data Sharing

IPD Sharing
Will not share

Locations