An interventional study of Self-Directed Therapeutic Rehab using In-room Virtual Entertainment (STRIVE) in Stroke, sponsored by Milap Sandhu. Recruiting at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-08.
Sponsored by Milap Sandhu · Not applicable, Interventional, and Treatment
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.
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.
8,255 studies on the registry are indexed under Stroke; 2,056 are open to participants now.
This study's planned enrollment of 30 is below the median of 49 across 6,024 interventional studies indexed under Stroke.
Browse Stroke studies →Milap Sandhu is the lead sponsor of 5 studies on the registry; 4 are open to participants now.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants using STRIVE
Other: Self-Directed Therapeutic Rehab using In-room Virtual Entertainment (STRIVE)
In-room upper extremity gaming system using markerless motion tracking
Observational Notes
Taken by study staff during session. Notes are entered into structured template.
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)
Adherence Notes
Study staff record days of attempted use and reasons for missed days, when available.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Every session during phase 1 (months 3-4) and phase 4 (months 15-18)
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)
Time frame: All sessions of each participant in phase 4 (months 15-18)
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.
Time frame: 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)
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.
Time frame: 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
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.
Time frame: Every session in phase 4 (months 15-18)
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.
Time frame: 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.
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.
Time frame: 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.
Participant movement smoothness
Movement smoothness of the more affected upper limb during STRIVE gameplay, quantified as log dimensionless jerk from motion data from the STRIVE system. Values are computed per reaching repetition and averaged across all repetitions within a session. Lower (more negative) values indicate smoother movement. This measure is reported in unitless log dimensionless jerk.
Time frame: Every session in phase 1 (months 3-4) and phase 4 (months 15-18)
Plan to share: No
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