AzTrials
AzTrials

StrokeNCT07806097

Self-Directed Upper Extremity Gaming in Inpatients With Stroke

A study testing Self-Directed Therapeutic Rehab using In-room Virtual Entertainment (STRIVE) in people with Stroke, run by Milap Sandhu at 1 site in United States.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Stroke
What is being tested?
Self-Directed Therapeutic Rehab using In-room Virtual Entertainment (STRIVE)
Could I receive a placebo?
No, everyone receives an active treatment
How many people
30 participants
Where
1 siteUnited States
Study dates
20 Jul 2026to 20 Dec 2027
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Rachel A Kalvakota, OTD, OTR/L contact

3122383947

rkalvakota@sralab.org

United States1 site, 1 recruiting

  • Shirley Ryan AbilityLab

    Chicago, Illinois, 60611-3167

    Rachel A Kalvakota, OTD, OTR/L, 3122383947, rkalvakota@sralab.org

    Recruiting

Other trials in United States

About this study

Official title: Self-Directed Upper Extremity Gaming in Inpatients With Stroke: A Feasibility Study

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.

Read the detailed description

This is a prospective, single-arm feasibility study using a four-phase co-design protocol adapted from Clanchy et al. Phase 1 (n=20): inpatient stroke survivors complete one supervised session; think-aloud methods capture usability barriers. Phase 2: a multidisciplinary translation team rates issues on clinical significance and technical feasibility. Phase 3: prioritized issues are translated into design changes, producing STRIVEv2, with each change traceable to a user-identified barrier. Phase 4 (n=20): a separate group uses STRIVEv2 over three or more consecutive daily sessions under naturalistic conditions to evaluate usability readiness.

An occupational therapist sets up equipment, calibrates, and runs a supervised practice session so participants can start, pause, and stop safely. Sessions occur only when participants are awake, alert, and medically stable. The system logs only de-identified session metadata (timestamps, duration, active play time, task attempts and completions, game scores). No video, audio, or images are recorded.

Conditions
Stroke
Being tested
Self-Directed Therapeutic Rehab using In-room Virtual Entertainment (STRIVE)
Keywords
gaming, upper extremity, occupational therapy, dosage, reps
Medical subject headings
Stroke

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

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

    In-room upper extremity gaming system using markerless motion tracking

Study groups in NCT07806097
Study groupRoleWhat they receive
STRIVE participantsExperimentalParticipants using STRIVE
Receives: Other: Self-Directed Therapeutic Rehab using In-room Virtual Entertainment (STRIVE)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Observational Notes

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

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

  2. Adherence Notes

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

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

  3. 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.

    Measured: 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.

  4. 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.

    Measured: 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.

  5. 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.

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

  6. 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.

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

Secondary outcomes (6)

  1. Rates and incidents

    Adverse events (recorded as note to files), safety events (recorded as note to files), staff support time required (recorded total minutes per staff per participant)

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

  2. Intrinsic Motivation Inventory (IMI)- short form

    Descriptive assessment of interest/enjoyment and perceived competence. 8-14 items. Items are rated on a likert scale of 1-7, where the higher the score, with a 7 indicating the participant strongly agrees the item statement.

    Measured: 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.

  3. Pittsburgh Rehabilitation Participation Scale (PRPS)

    Rated via observation of participant engaging in STRIVE during a typical session by a member of the study team. 6- point Likert-type scale, with a 0 indicating no participation, and 6 indicating excellent participation.

    Measured: 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.

  4. Number of STRIVE Sessions Completed

    Feasibility of the STRIVE intervention, measured as the number of STRIVE sessions each participant completed over the intervention period. A session is considered completed if the participant engaged with the STRIVE system for at least 30 minutes per day and the session is logged by the system. Sessions that were started but did not meet this threshold, and sessions missed for any reason, are counted as not completed. Each participant is assigned a single count, and the number of completed sessions is reported as a mean across participants. Higher values indicate greater intervention uptake.

    Measured: Every session in phase 4 (months 15-18)

  5. Participant-Rated Acceptability of the STRIVE System

    Acceptability of STRIVE rated by participants on a custom 10-item questionnaire administered verbally or on paper. Each item is scored on a 5-point Likert scale from 1 to 5, and item scores are averaged to yield a single mean score ranging from 1 to 5. Higher scores indicate greater acceptability. This is a non-validated instrument developed for this study.

    Measured: 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.

  6. Semi-Structured Qualitative Interview

    Participants complete a semi-structured qualitative interview with open-ended prompts addressing acceptability, perceived benefit, barriers to independent use, and suggestions for improvement. Responses are transcribed and coded. The reported value is the count of distinct usability issues identified across participants, where an issue is defined as a discrete, non-redundant barrier to independent system use.

    Measured: 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.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted8 Sep 2026
  2. Study start20 Jul 2026
  3. Primary completion20 Jul 2027 (estimated)
  4. Study completion20 Dec 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
30 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07806097
Sponsor's protocol ID
STU00224942
Status last verified
Sep 2026
First submitted
21 Jul 2026
Last updated
8 Sep 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing Self-Directed Therapeutic Rehab using In-room Virtual Entertainment (STRIVE) in people with Stroke, run by Milap Sandhu at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 8 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Rachel A Kalvakota, OTD, OTR/L (3122383947, rkalvakota@sralab.org), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Observational Notes (time frame: During every session throughout phase 1 (months 3-4) --and during at least 2 sessions for every participant during phase 4 (months 15-18)). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07806097.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Sep 2026; AzTrials last refreshed its copy on 30 Oct 2026.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Keep searching with a free account

You’ve used your 3 free searches for this session. Log in or create a free AzTrials account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in