Self-Directed Upper Extremity Gaming in Inpatients With Stroke

ConditionStroke
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorMilap Sandhu

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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 design

Design model

Single group

Treatments tested in this trial

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

    Other intervention

    In-room upper extremity gaming system using markerless motion tracking

Treatment groups

30 Participants
are divided into 1 treatment group
Group A: STRIVE participantsExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

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)
2

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)
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.

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.
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.

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.

Secondary outcomes

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)

Time frame
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.

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.
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.

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.
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.

Time frame
Every session in phase 4 (months 15-18)

Other outcomes

1

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)

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Milap Sandhu

Lead sponsor

Shirley Ryan AbilityLab

Sponsor institution