Trial Outcomes & Findings for Prism Adaptation in Left Brain Stroke (NCT NCT04387162)
NCT ID: NCT04387162
Last Updated: 2025-04-09
Results Overview
Assessment of satisfaction and perceived value of Prism Adaptation Treatment; scores range from 8-32, with higher scores indicating greater satisfaction
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
13 participants
Primary outcome timeframe
Immediately following the two-week treatment (study week 3 in immediate group, study week 5 in delayed group)
Results posted on
2025-04-09
Participant Flow
Eight participants were consented into the study to complete screening procedures and ultimately did not meet eligibility criteria. These eight participants were not assigned to a study group.
Participant milestones
| Measure |
Immediate
Participants will enter treatment after one week baseline
Prism Adaptation Treatment: Spatial retraining treatment
|
Delayed
Participants will enter treatment after two week baseline
Prism Adaptation Treatment: Spatial retraining treatment
|
|---|---|---|
|
Overall Study
STARTED
|
3
|
2
|
|
Overall Study
COMPLETED
|
3
|
2
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Prism Adaptation in Left Brain Stroke
Baseline characteristics by cohort
| Measure |
Immediate
n=3 Participants
Participants will enter treatment after one week baseline
Prism Adaptation Treatment: Spatial retraining treatment
|
Delayed
n=2 Participants
Participants will enter treatment after two week baseline
Prism Adaptation Treatment: Spatial retraining treatment
|
Total
n=5 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
68.3 years
STANDARD_DEVIATION 9.1 • n=5 Participants
|
53.5 years
STANDARD_DEVIATION 3.5 • n=7 Participants
|
62.4 years
STANDARD_DEVIATION 10.5 • n=5 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
3 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
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 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
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 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
|
3 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Immediately following the two-week treatment (study week 3 in immediate group, study week 5 in delayed group)Assessment of satisfaction and perceived value of Prism Adaptation Treatment; scores range from 8-32, with higher scores indicating greater satisfaction
Outcome measures
| Measure |
Immediate
n=3 Participants
Participants will enter treatment after one week baseline
Prism Adaptation Treatment: Spatial retraining treatment
|
Delayed
n=2 Participants
Participants will enter treatment after two week baseline
Prism Adaptation Treatment: Spatial retraining treatment
|
|---|---|---|
|
Client Satisfaction Questionnaire
|
32 score on a scale
Standard Deviation 0
|
27 score on a scale
Standard Deviation 4.2
|
PRIMARY outcome
Timeframe: Immediately following the two-week treatment (study week 3 in immediate group, study week 5 in delayed group)Assessment of whether Prism Adaptation Treatment is believable, convincing and logical (credibility) and the expectations for treatment-induced improvement (expectancy); two rating scales with one scale ranging from 1-9 and from 0%-100%, with higher scores indicating greater credibility and expectancy.
Outcome measures
| Measure |
Immediate
n=3 Participants
Participants will enter treatment after one week baseline
Prism Adaptation Treatment: Spatial retraining treatment
|
Delayed
n=2 Participants
Participants will enter treatment after two week baseline
Prism Adaptation Treatment: Spatial retraining treatment
|
|---|---|---|
|
Credibility/Expectancy Questionnaire
Credibility
|
6.2 score on a scale
Standard Deviation 1.6
|
8.0 score on a scale
Standard Deviation .89
|
|
Credibility/Expectancy Questionnaire
Expectancy
|
56.7 score on a scale
Standard Deviation 30.6
|
75.0 score on a scale
Standard Deviation 7.1
|
PRIMARY outcome
Timeframe: Weekly from baseline to follow-up (study week 7); baseline to immediate post-treatment (study week 3 in immediate group, study week 5 in delayed group), baseline to two weeks post-treatment (study week 7)Assessment of functional disability by activities of daily living; scores range from 0-100, with higher score indicating greater independence and less functional disability
Outcome measures
| Measure |
Immediate
n=3 Participants
Participants will enter treatment after one week baseline
Prism Adaptation Treatment: Spatial retraining treatment
|
Delayed
n=2 Participants
Participants will enter treatment after two week baseline
Prism Adaptation Treatment: Spatial retraining treatment
|
|---|---|---|
|
Barthel Index
Baseline
|
70.8 Score on a scale
Standard Deviation 23.5
|
86.9 Score on a scale
Standard Deviation 10.9
|
|
Barthel Index
Immediate Post-Treatment
|
75.0 Score on a scale
Standard Deviation 22.9
|
82.5 Score on a scale
Standard Deviation 10.6
|
|
Barthel Index
Two Weeks Post-Treatment
|
71.7 Score on a scale
Standard Deviation 24.7
|
85.0 Score on a scale
Standard Deviation 7.1
|
PRIMARY outcome
Timeframe: Weekly from baseline to follow-up (study week 7); baseline to immediate post-treatment (study week 3 in immediate group, study week 5 in delayed group), baseline to two weeks post-treatment (study week 7)Assessment of cognitive and motor function; scores range from 18-126, with a higher score indicating greater functional independence
Outcome measures
| Measure |
Immediate
n=3 Participants
Participants will enter treatment after one week baseline
Prism Adaptation Treatment: Spatial retraining treatment
|
Delayed
n=2 Participants
Participants will enter treatment after two week baseline
Prism Adaptation Treatment: Spatial retraining treatment
|
|---|---|---|
|
Functional Independence Measure
Baseline
|
88.2 Score on a scale
Standard Deviation 18.9
|
97.7 Score on a scale
Standard Deviation 9.1
|
|
Functional Independence Measure
Immediate Post-Treatment
|
94.7 Score on a scale
Standard Deviation 21.7
|
98.5 Score on a scale
Standard Deviation 13.4
|
|
Functional Independence Measure
Two Weeks Post-Treatment
|
95.0 Score on a scale
Standard Deviation 20.9
|
99.5 Score on a scale
Standard Deviation 13.4
|
PRIMARY outcome
Timeframe: Weekly from baseline to follow-up (study week 7); baseline to immediate post-treatment (study week 3 in immediate group, study week 5 in delayed group), baseline to two weeks post-treatment (study week 7)Assessment of spatial neglect; scores range from 0-146, with lower scores indicating more severe spatial neglect
Outcome measures
| Measure |
Immediate
n=3 Participants
Participants will enter treatment after one week baseline
Prism Adaptation Treatment: Spatial retraining treatment
|
Delayed
n=2 Participants
Participants will enter treatment after two week baseline
Prism Adaptation Treatment: Spatial retraining treatment
|
|---|---|---|
|
Behavioral Inattention Test- Conventional Subtest
Baseline
|
115.3 Score on a scale
Standard Deviation 45.7
|
120.4 Score on a scale
Standard Deviation 5.3
|
|
Behavioral Inattention Test- Conventional Subtest
Immediate Post-Treatment
|
127.6 Score on a scale
Standard Deviation 24.9
|
119.0 Score on a scale
Standard Deviation 19.8
|
|
Behavioral Inattention Test- Conventional Subtest
Two Weeks Post-Treatment
|
127.3 Score on a scale
Standard Deviation 26.3
|
123.5 Score on a scale
Standard Deviation 3.5
|
PRIMARY outcome
Timeframe: Weekly from baseline to follow-up (study week 7); baseline to immediate post-treatment (study week 3 in immediate group, study week 5 in delayed group), baseline to two weeks post-treatment (study week 7)Assessment of spatial neglect; scores range from 0-30, with higher scores indicating more severe spatial neglect
Outcome measures
| Measure |
Immediate
n=3 Participants
Participants will enter treatment after one week baseline
Prism Adaptation Treatment: Spatial retraining treatment
|
Delayed
n=2 Participants
Participants will enter treatment after two week baseline
Prism Adaptation Treatment: Spatial retraining treatment
|
|---|---|---|
|
Catherine Bergego Scale Via the Kessler Foundation Neglect Assessment Process
Baseline
|
3.6 Score on a scale
Standard Deviation 2.6
|
3.2 Score on a scale
Standard Deviation 2.4
|
|
Catherine Bergego Scale Via the Kessler Foundation Neglect Assessment Process
Immediate Post-Treatment
|
1.5 Score on a scale
Standard Deviation 2.6
|
1.5 Score on a scale
Standard Deviation 2.1
|
|
Catherine Bergego Scale Via the Kessler Foundation Neglect Assessment Process
Two Weeks Post-Treatment
|
1.5 Score on a scale
Standard Deviation 2.6
|
2.5 Score on a scale
Standard Deviation 3.5
|
PRIMARY outcome
Timeframe: Weekly from baseline to follow-up (study week 7); baseline to immediate post-treatment (study week 3 in immediate group, study week 5 in delayed group), baseline to two weeks post-treatment (study week 7)Assessment of motor function; scores range from 0-75, with higher scores indicating less impairment in motor function
Outcome measures
| Measure |
Immediate
n=3 Participants
Participants will enter treatment after one week baseline
Prism Adaptation Treatment: Spatial retraining treatment
|
Delayed
n=2 Participants
Participants will enter treatment after two week baseline
Prism Adaptation Treatment: Spatial retraining treatment
|
|---|---|---|
|
Wolf Motor Function Test
Baseline
|
35.5 Score on a scale
Standard Deviation 30.7
|
54.3 Score on a scale
Standard Deviation 22.8
|
|
Wolf Motor Function Test
Immediate Post-Treatment
|
35.7 Score on a scale
Standard Deviation 34.2
|
63.0 Score on a scale
Standard Deviation 14.1
|
|
Wolf Motor Function Test
Two Weeks Post-Treatment
|
35.0 Score on a scale
Standard Deviation 34.7
|
65.0 Score on a scale
Standard Deviation 12.7
|
PRIMARY outcome
Timeframe: Weekly from baseline to follow-up (study week 7); baseline to immediate post-treatment (study week 3 in immediate group, study week 5 in delayed group), baseline to two weeks post-treatment (study week 7)Assessment of pain; scores range from 0-10, with higher scores indicating more severe pain
Outcome measures
| Measure |
Immediate
n=3 Participants
Participants will enter treatment after one week baseline
Prism Adaptation Treatment: Spatial retraining treatment
|
Delayed
n=2 Participants
Participants will enter treatment after two week baseline
Prism Adaptation Treatment: Spatial retraining treatment
|
|---|---|---|
|
Defense and Veterans Pain Rating Scale
Baseline
|
0.5 Score on a scale
Standard Deviation 0.84
|
3.7 Score on a scale
Standard Deviation 2.2
|
|
Defense and Veterans Pain Rating Scale
Immediate Post-Treatment
|
0.0 Score on a scale
Standard Deviation 0.0
|
3.5 Score on a scale
Standard Deviation 2.8
|
|
Defense and Veterans Pain Rating Scale
Two Weeks Post-Treatment
|
0.7 Score on a scale
Standard Deviation 1.2
|
1.5 Score on a scale
Standard Deviation 2.1
|
PRIMARY outcome
Timeframe: BaselinePopulation: Unable to obtain records to complete this analysis
Assessment of whether lesion is "frontal" or "nonfrontal"
Outcome measures
| Measure |
Immediate
n=3 Participants
Participants will enter treatment after one week baseline
Prism Adaptation Treatment: Spatial retraining treatment
|
Delayed
n=2 Participants
Participants will enter treatment after two week baseline
Prism Adaptation Treatment: Spatial retraining treatment
|
|---|---|---|
|
Classification of Lesion Location
|
0 Participants
|
0 Participants
|
Adverse Events
Immediate
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Delayed
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
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place