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Self-Directed Upper Extremity Gaming in Inpatients With Stroke

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

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07806097
Enrollment
30
Registered
2026-09-08
Start date
2026-07-20
Completion date
2027-12-20
Last updated
2026-09-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Stroke

Keywords

gaming, upper extremity, occupational therapy, dosage, reps

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.

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.

Interventions

OTHERSelf-Directed Therapeutic Rehab using In-room Virtual Entertainment (STRIVE)

In-room upper extremity gaming system using markerless motion tracking

Sponsors

Milap Sandhu
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* 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

Exclusion criteria

* 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

Design outcomes

Primary

MeasureTime frameDescription
Observational NotesDuring every session throughout phase 1 (months 3-4) --and during at least 2 sessions for every participant during phase 4 (months 15-18)Taken by study staff during session. Notes are entered into structured template.
Adherence NotesThroughout all sessions during phase 4 (months 15-18)Study staff record days of attempted use and reasons for missed days, when available.
System Usability Scale (SUS)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.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.
Quebec User Evaluation of Satisfaction with Assistive Technology (QUEST)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.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.
STRIVE system logsThroughout phase 1 (months 3-4) and phase 4 (months 15-18)STRIVE will automatically record data that includes session start/end time, duration, active play time, number of sessions completed, and performance metrics.
Total time of Engagement for StriveEvery session during phase 1 (months 3-4) and phase 4 (months 15-18)STRIVE will automatically record data that includes session start/end time. Duration will be calculated via END\_TIME-START\_TIME.

Secondary

MeasureTime frameDescription
Rates and incidentsAll sessions of each participant in phase 4 (months 15-18)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)
Intrinsic Motivation Inventory (IMI)- short formAll 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.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.
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.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.
Number of STRIVE Sessions CompletedEvery session in phase 4 (months 15-18)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.
Participant-Rated Acceptability of the STRIVE SystemAll 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.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.
Semi-Structured Qualitative InterviewAll 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.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.

Countries

United States

Contacts

CONTACTRachel A Kalvakota, OTD, OTR/L
rkalvakota@sralab.org3122383947
PRINCIPAL_INVESTIGATORMilap Sandhu

Shirley Ryan AbilityLab

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Sep 9, 2026