Trial Outcomes & Findings for Utilizing Gaming Mechanics to Optimize Telerehabilitation Adherence in Persons With Stroke (NCT NCT03985761)

NCT ID: NCT03985761

Last Updated: 2024-09-19

Results Overview

Total intervention time performed by patient during study period

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 33 participants
• Primary outcome timeframe: Day one through day ninety of intervention period
• Results posted on: 2024-09-19

Participant Flow

48 subjects screened 15 pre-assignment screen failures due to insufficient motor or sensory function

Participant milestones

Measure	Home Telerehabilitation_Motivation Enhanced HTme 12 Weeks Training - Motivation enhanced games	Home Telerehabilitation_Unenhanced (HTu) 12 weeks training - unenhanced, algorithm controlled games,
Overall Study STARTED	17	16
Overall Study COMPLETED	15	13
Overall Study NOT COMPLETED	2	3

Reasons for withdrawal

Measure	Home Telerehabilitation_Motivation Enhanced HTme 12 Weeks Training - Motivation enhanced games	Home Telerehabilitation_Unenhanced (HTu) 12 weeks training - unenhanced, algorithm controlled games,
Overall Study Withdrawal by Subject	2	3

Baseline Characteristics

Utilizing Gaming Mechanics to Optimize Telerehabilitation Adherence in Persons With Stroke

Baseline characteristics by cohort

Measure	Home Telerehabilitation_Motivation Enhanced HTme n=15 Participants 12 Weeks Training - Motivation enhanced games	Home Telerehabilitation_Unenhanced (HTu) n=13 Participants 12 weeks training - unenhanced, algorithm controlled games,	Total n=28 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	10 Participants n=5 Participants	11 Participants n=7 Participants	21 Participants n=5 Participants
Age, Categorical >=65 years	5 Participants n=5 Participants	2 Participants n=7 Participants	7 Participants n=5 Participants
Age, Continuous	58 years STANDARD_DEVIATION 11.1 • n=5 Participants	55.9 years STANDARD_DEVIATION 14.5 • n=7 Participants	56.7 years STANDARD_DEVIATION 12.7 • n=5 Participants
Sex: Female, Male Female	13 Participants n=5 Participants	9 Participants n=7 Participants	22 Participants n=5 Participants
Sex: Female, Male Male	2 Participants n=5 Participants	4 Participants n=7 Participants	6 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	2 Participants n=5 Participants	2 Participants n=7 Participants	4 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	13 Participants n=5 Participants	11 Participants n=7 Participants	24 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	1 Participants n=5 Participants	2 Participants n=7 Participants	3 Participants n=5 Participants
Race (NIH/OMB) White	13 Participants n=5 Participants	10 Participants n=7 Participants	23 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Region of Enrollment United States	15 participants n=5 Participants	13 participants n=7 Participants	28 participants n=5 Participants
Time since stroke in months	29 Months STANDARD_DEVIATION 28.8 • n=5 Participants	63 Months STANDARD_DEVIATION 84 • n=7 Participants	47.3 Months STANDARD_DEVIATION 64.8 • n=5 Participants
Severity of stroke as measured by Upper Extremity Fugl Meyer Assessment	43 units on a scale STANDARD_DEVIATION 14 • n=5 Participants	43 units on a scale STANDARD_DEVIATION 12 • n=7 Participants	43 units on a scale STANDARD_DEVIATION 13 • n=5 Participants

PRIMARY outcome

Timeframe: Day one through day ninety of intervention period

Total intervention time performed by patient during study period

Outcome measures

Measure	Home Telerehabilitation_Motivation Enhanced HTme n=15 Participants 12 Weeks Training - Motivation enhanced games	Home Telerehabilitation_Unenhanced (HTu) n=13 Participants 12 weeks training - unenhanced, algorithm controlled games,
Total Intervention Time	966 Minutes Interval 442.0 to 1570.0	680 Minutes Interval 412.0 to 902.0

PRIMARY outcome

Timeframe: 12 weeks

Difference between post test and pretest Upper Extremity Fugl Meyer Assessment Scores. Scores between 0 and 66. The Upper Extremity Fugl-Meyer Assessment is a clinical scale that is a composite measure of 33 performance based items, scored 0,1 or 2. Total score reflects the sum of the 33 individual item scores. Higher scores reflect better performance.

Outcome measures

Measure	Home Telerehabilitation_Motivation Enhanced HTme n=15 Participants 12 Weeks Training - Motivation enhanced games	Home Telerehabilitation_Unenhanced (HTu) n=13 Participants 12 weeks training - unenhanced, algorithm controlled games,
Upper Extremity Fugl Meyer Assessment	5.23 units on a scale Standard Deviation 3.2	6.4 units on a scale Standard Deviation 2.5

PRIMARY outcome

Timeframe: 12 weeks

Difference between score measured three months after baseline and the score measured at baseline on the Intrinsic Motivation Inventory. Scores range = 0-84. Higher score equals higher levels of intrinsic motivation.

Outcome measures

Measure	Home Telerehabilitation_Motivation Enhanced HTme n=15 Participants 12 Weeks Training - Motivation enhanced games	Home Telerehabilitation_Unenhanced (HTu) n=13 Participants 12 weeks training - unenhanced, algorithm controlled games,
Intrinsic Motivation Inventory	5.62 score on a scale Standard Deviation 4.4	4.22 score on a scale Standard Deviation 5.7

SECONDARY outcome

Timeframe: Day one through day ninety of intervention period

Average intervention time performed by the subject

Outcome measures

Measure	Home Telerehabilitation_Motivation Enhanced HTme n=15 Participants 12 Weeks Training - Motivation enhanced games	Home Telerehabilitation_Unenhanced (HTu) n=13 Participants 12 weeks training - unenhanced, algorithm controlled games,
Average Intervention Time Per Intervention Day	20.9 Minutes Standard Deviation 9	20.9 Minutes Standard Deviation 11

SECONDARY outcome

Timeframe: 12 weeks.

Difference between score measured three months after baseline and the score measured at baseline on the Action Research Arm Test. Range = 0 - 57. Higher scores = better function.

Outcome measures

Measure	Home Telerehabilitation_Motivation Enhanced HTme n=15 Participants 12 Weeks Training - Motivation enhanced games	Home Telerehabilitation_Unenhanced (HTu) n=13 Participants 12 weeks training - unenhanced, algorithm controlled games,
Action Research Arm Test	5.62 score on a scale Standard Deviation 4.9	3.47 score on a scale Standard Deviation 3.9

SECONDARY outcome

Timeframe: 12 weeks

Difference between posttest and pretest Box and Blocks Test scores. Score reflects the number of blocks transported from one receptacle to another in sixty seconds using the stroke impaired hand. Higher scores reflect better performance.

Outcome measures

Measure	Home Telerehabilitation_Motivation Enhanced HTme n=15 Participants 12 Weeks Training - Motivation enhanced games	Home Telerehabilitation_Unenhanced (HTu) n=13 Participants 12 weeks training - unenhanced, algorithm controlled games,
Box and Blocks Test	3.7 Blocks moved in 60 seconds Standard Deviation 3.1	2.9 Blocks moved in 60 seconds Standard Deviation 3.0

OTHER_PRE_SPECIFIED outcome

Timeframe: 12 weeks.

Difference between posttest and pretest score on the Stroke Impact Scales Hand Subscale. Range = 0 - 25. Higher score = better recovery. Subscales reported individually.

Outcome measures

Measure	Home Telerehabilitation_Motivation Enhanced HTme n=15 Participants 12 Weeks Training - Motivation enhanced games	Home Telerehabilitation_Unenhanced (HTu) n=13 Participants 12 weeks training - unenhanced, algorithm controlled games,
Stroke Impact Scale - Hand Subscale	1.81 score on a scale Standard Deviation 2.5	0.82 score on a scale Standard Deviation 3.7

OTHER_PRE_SPECIFIED outcome

Timeframe: 12 weeks.

Difference between score measured three months after baseline and the score measured at baseline on the Stroke Impact Scales Activities of Daily Living subscale. Range = 0-50. Higher score = better recovery.

Outcome measures

Measure	Home Telerehabilitation_Motivation Enhanced HTme n=15 Participants 12 Weeks Training - Motivation enhanced games	Home Telerehabilitation_Unenhanced (HTu) n=13 Participants 12 weeks training - unenhanced, algorithm controlled games,
Stroke Impact Scale - Activities of Daily Living Subscale	3.39 score on a scale Standard Deviation 2.2	1.77 score on a scale Standard Deviation 2.9

OTHER_PRE_SPECIFIED outcome

Timeframe: 12 weeks

Number of training sessions performed by subject during training period

Outcome measures

Measure	Home Telerehabilitation_Motivation Enhanced HTme n=15 Participants 12 Weeks Training - Motivation enhanced games	Home Telerehabilitation_Unenhanced (HTu) n=13 Participants 12 weeks training - unenhanced, algorithm controlled games,
Total Training Sessions	47.7 Sessions Standard Deviation 16.4	37.1 Sessions Standard Deviation 18.4

OTHER_PRE_SPECIFIED outcome

Timeframe: 12 weeks.

Difference between score measured three months after baseline and the score measured at baseline on the Stroke Impact Scales Participation Subscale. Range = 0 - 40. Higher scores = higher levels of participation.

Outcome measures

Measure	Home Telerehabilitation_Motivation Enhanced HTme n=15 Participants 12 Weeks Training - Motivation enhanced games	Home Telerehabilitation_Unenhanced (HTu) n=13 Participants 12 weeks training - unenhanced, algorithm controlled games,
Stroke Impact Scales Participation Subscale	2.05 score on a scale Standard Deviation 2.5	1.66 score on a scale Standard Deviation 2.7

Adverse Events

Home Telerehabilitation_Motivation Enhanced HTme

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Home Telerehabilitation_Unenhanced (HTu)

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Gerard G Fluet DPT, PhD

Rutgers The State University of NJ

Phone: (973) 972-8529

Email: fluetge@shp.rutgers.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place