Trial Outcomes & Findings for Motor Control Physical Therapist Support Stroke (NCT NCT04856527)
NCT ID: NCT04856527
Last Updated: 2024-08-21
Results Overview
The amount of displacement of the location of the (resultant) vertical ground reaction force vector. Results only presented as the mean difference between groups, as only the paretic limb was used for this portion of the study. There are no results to report for the non-paretic limb.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
25 participants
Primary outcome timeframe
10 minutes of practice
Results posted on
2024-08-21
Participant Flow
Unit of analysis: Limbs (Paretic/Non-Paretic)
Participant milestones
| Measure |
Experimental Group
Participants will receive physical therapist support to reduce postural sway while completing a precision aiming task in virtual reality, whether or not they require the support.
Physical therapist support: Participants will receive physical therapist support to reduce postural sway variability while completing an upper limb precision aiming task in virtual reality.
|
Control Group
Participants will receive no physical therapist support while completing the task.
|
|---|---|---|
|
Overall Study
STARTED
|
13 26
|
12 24
|
|
Overall Study
COMPLETED
|
11 22
|
12 24
|
|
Overall Study
NOT COMPLETED
|
2 4
|
0 0
|
Reasons for withdrawal
| Measure |
Experimental Group
Participants will receive physical therapist support to reduce postural sway while completing a precision aiming task in virtual reality, whether or not they require the support.
Physical therapist support: Participants will receive physical therapist support to reduce postural sway variability while completing an upper limb precision aiming task in virtual reality.
|
Control Group
Participants will receive no physical therapist support while completing the task.
|
|---|---|---|
|
Overall Study
Unable to complete experimental task
|
2
|
0
|
Baseline Characteristics
Motor Control Physical Therapist Support Stroke
Baseline characteristics by cohort
| Measure |
Experimental Group
n=11 Participants
Participants will receive physical therapist support to reduce postural sway while completing a precision aiming task in virtual reality, whether or not they require the support.
Physical therapist support: Participants will receive physical therapist support to reduce postural sway variability while completing an upper limb precision aiming task in virtual reality.
|
Control Group
n=12 Participants
Participants will receive no physical therapist support while completing the task.
|
Total
n=23 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
57 years
STANDARD_DEVIATION 4.3 • n=5 Participants
|
50.8 years
STANDARD_DEVIATION 8.4 • n=7 Participants
|
53.7 years
STANDARD_DEVIATION 7.3 • n=5 Participants
|
|
Sex: Female, Male
Female
|
7 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
17 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
4 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
11 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
23 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
|
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
|
4 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
7 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
12 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
|
PRIMARY outcome
Timeframe: 10 minutes of practicePopulation: Difference between path length during practice.
The amount of displacement of the location of the (resultant) vertical ground reaction force vector. Results only presented as the mean difference between groups, as only the paretic limb was used for this portion of the study. There are no results to report for the non-paretic limb.
Outcome measures
| Measure |
Experimental Group
n=11 Participants
Participants will receive physical therapist support to reduce postural sway while completing a precision aiming task in virtual reality, whether or not they require the support.
Physical therapist support: Participants will receive physical therapist support to reduce postural sway variability while completing an upper limb precision aiming task in virtual reality.
|
Control Group
n=12 Participants
Participants will receive no physical therapist support while completing the task.
|
Experimental Group: Non-Paretic Limb
Participants will receive physical therapist support to reduce postural sway while completing a precision aiming task in virtual reality, whether or not they require the support.
Physical therapist support: Participants will receive physical therapist support to reduce postural sway variability while completing an upper limb precision aiming task in virtual reality.
|
Control Group Non-Paretic Limb
Participants will receive no physical therapist support while completing the task.
|
|---|---|---|---|---|
|
Center of Pressure Path Length
|
98.5 cm^2
Standard Error 17.5
|
156.1 cm^2
Standard Error 16.8
|
—
|
—
|
PRIMARY outcome
Timeframe: After 10 minutes of practicePopulation: Post-test results from when participants were aiming with each upper limb.
Variability of center of pressure trajectory.
Outcome measures
| Measure |
Experimental Group
n=11 Participants
Participants will receive physical therapist support to reduce postural sway while completing a precision aiming task in virtual reality, whether or not they require the support.
Physical therapist support: Participants will receive physical therapist support to reduce postural sway variability while completing an upper limb precision aiming task in virtual reality.
|
Control Group
n=12 Participants
Participants will receive no physical therapist support while completing the task.
|
Experimental Group: Non-Paretic Limb
n=11 Participants
Participants will receive physical therapist support to reduce postural sway while completing a precision aiming task in virtual reality, whether or not they require the support.
Physical therapist support: Participants will receive physical therapist support to reduce postural sway variability while completing an upper limb precision aiming task in virtual reality.
|
Control Group Non-Paretic Limb
n=12 Participants
Participants will receive no physical therapist support while completing the task.
|
|---|---|---|---|---|
|
Standard Deviation of Center of Pressure
|
.70 cm
Standard Error .06
|
.53 cm
Standard Error .05
|
.69 cm
Standard Error .04
|
.53 cm
Standard Error .04
|
PRIMARY outcome
Timeframe: After 10 minutes of practicePopulation: Post-test results
Quantifies the patterning, non-stationarity, and complexity of biological time series through the analysis of local recurrences in a reconstructed phase space. Highter values of percent determinism indicate more regularity in postural sway.
Outcome measures
| Measure |
Experimental Group
n=11 Participants
Participants will receive physical therapist support to reduce postural sway while completing a precision aiming task in virtual reality, whether or not they require the support.
Physical therapist support: Participants will receive physical therapist support to reduce postural sway variability while completing an upper limb precision aiming task in virtual reality.
|
Control Group
n=12 Participants
Participants will receive no physical therapist support while completing the task.
|
Experimental Group: Non-Paretic Limb
n=11 Participants
Participants will receive physical therapist support to reduce postural sway while completing a precision aiming task in virtual reality, whether or not they require the support.
Physical therapist support: Participants will receive physical therapist support to reduce postural sway variability while completing an upper limb precision aiming task in virtual reality.
|
Control Group Non-Paretic Limb
n=12 Participants
Participants will receive no physical therapist support while completing the task.
|
|---|---|---|---|---|
|
Percent Determinism of Postural Sway
|
.99 percent determinism
Standard Error .001
|
.99 percent determinism
Standard Error .001
|
.99 percent determinism
Standard Error .001
|
.99 percent determinism
Standard Error .001
|
PRIMARY outcome
Timeframe: After 10 minutes of practicePopulation: Post-test results
Evaluates the predictability of the next state of a system, given what is known about the current state of a system. Higher values of SampEn indicate less regularity; lower values indicate more regularity. Outcome measure reported as a ratio of anterior-posterior to medial-lateral SampEn values.
Outcome measures
| Measure |
Experimental Group
n=11 Participants
Participants will receive physical therapist support to reduce postural sway while completing a precision aiming task in virtual reality, whether or not they require the support.
Physical therapist support: Participants will receive physical therapist support to reduce postural sway variability while completing an upper limb precision aiming task in virtual reality.
|
Control Group
n=12 Participants
Participants will receive no physical therapist support while completing the task.
|
Experimental Group: Non-Paretic Limb
n=11 Participants
Participants will receive physical therapist support to reduce postural sway while completing a precision aiming task in virtual reality, whether or not they require the support.
Physical therapist support: Participants will receive physical therapist support to reduce postural sway variability while completing an upper limb precision aiming task in virtual reality.
|
Control Group Non-Paretic Limb
n=12 Participants
Participants will receive no physical therapist support while completing the task.
|
|---|---|---|---|---|
|
Entropy (Sample Entropy)
|
1.2 ratio of AP:ML
Standard Error .19
|
1.54 ratio of AP:ML
Standard Error .18
|
1.4 ratio of AP:ML
Standard Error .18
|
1.1 ratio of AP:ML
Standard Error .19
|
PRIMARY outcome
Timeframe: After 10 minutes of practicePopulation: Post-test results
Percent time on target.
Outcome measures
| Measure |
Experimental Group
n=11 Participants
Participants will receive physical therapist support to reduce postural sway while completing a precision aiming task in virtual reality, whether or not they require the support.
Physical therapist support: Participants will receive physical therapist support to reduce postural sway variability while completing an upper limb precision aiming task in virtual reality.
|
Control Group
n=12 Participants
Participants will receive no physical therapist support while completing the task.
|
Experimental Group: Non-Paretic Limb
n=11 Participants
Participants will receive physical therapist support to reduce postural sway while completing a precision aiming task in virtual reality, whether or not they require the support.
Physical therapist support: Participants will receive physical therapist support to reduce postural sway variability while completing an upper limb precision aiming task in virtual reality.
|
Control Group Non-Paretic Limb
n=12 Participants
Participants will receive no physical therapist support while completing the task.
|
|---|---|---|---|---|
|
Percent Correct
|
.66 percentage of time on target
Standard Error .08
|
.74 percentage of time on target
Standard Error .06
|
.95 percentage of time on target
Standard Error .01
|
.91 percentage of time on target
Standard Error .01
|
Adverse Events
Experimental Group
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Control Group
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Experimental Group
n=11 participants at risk
Participants will receive physical therapist support to reduce postural sway while completing a precision aiming task in virtual reality, whether or not they require the support.
Physical therapist support: Participants will receive physical therapist support to reduce postural sway variability while completing an upper limb precision aiming task in virtual reality.
|
Control Group
n=12 participants at risk
Participants will receive no physical therapist support while completing the task.
|
|---|---|---|
|
Musculoskeletal and connective tissue disorders
Fall
|
0.00%
0/11 • No adverse events occurred during the study (1 hour, single session). Participants were only assessed for adverse events during the 1-hour single session
There was no risk of death, a life-threatening adverse event, inpatient hospitalization or prolongation of existing hospitalization, a persistent or significant incapacity or substantial disruption of the ability to conduct normal functions, or a congenital anomaly/birth defect by participating in this study.
|
0.00%
0/12 • No adverse events occurred during the study (1 hour, single session). Participants were only assessed for adverse events during the 1-hour single session
There was no risk of death, a life-threatening adverse event, inpatient hospitalization or prolongation of existing hospitalization, a persistent or significant incapacity or substantial disruption of the ability to conduct normal functions, or a congenital anomaly/birth defect by participating in this study.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place