N/A
N=1
Effects of Post-Stroke Upper Extremity Assistance
Arm Weakness as a Consequence of Stroke
Bottom Line
View on ClinicalTrials.gov: NCT05036642 ↗Enrolled (actual)
1
Serious AEs
0.0%
Results posted
Oct 2023
Primary outcome: Primary: Wolf Motor Function Test - Change in Functional Score by Task (WMFT) — 7; 3; 5 Tasks
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Compliant Passive Arm Support (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Stanford University
- Primary completion
- Sep 2022
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Wolf Motor Function Test - Change in Functional Score by Task (WMFT) |
7; 3; 5 | — |
| PRIMARY Wolf Motor Function Test - Change in Completion Time by Task |
3; 0; 12 | — |
| PRIMARY Wolf Motor Function Test - Weight Lifted |
4.6; 6.1 | — |
| PRIMARY Percentage of Successful Motions |
57.5; 69.84 | 0.02 sig |
| PRIMARY Reachable Workspace - Mean Distance From Trunk, Successful Motions |
-0.07; -0.05 | 0.01 sig |
| PRIMARY Reachable Workspace - Area, Successful Motions |
0.078; 0.082 | 0.48 |
| PRIMARY Reachable Workspace - Mean Distance From Trunk, All Motions |
-0.14; -0.12 | — |
| SECONDARY Participant Satisfaction Survey |
3; 4; 1; 1; 1; 4 | — |
Summary
The purpose of this study is to quantify the improvement of post- stroke individuals' ability to move their arms during and after robot assisted therapy.
While researchers know that robot assisted therapies improve motor performance over the course of weeks, they do not know how motor performance is affected over the course of minutes or hours. A better understanding of how robot assisted therapies affect motor performance on short time scales may help us to prescribe more effective therapy doses to maximize motor recovery after neurological injury.
The study will allow us to obtain a detailed understanding of the performance of the device as described above.
Eligibility Criteria
Inclusion Criteria
- greater than 6 months post-stroke
- passive abduction to 90 degrees at shoulder
- reduced active (retro)flexion/extension at shoulder when abducted at 90 degrees
- reduced active flexion/extension at elbow
Exclusion Criteria
- unable to give informed consent
- unable to comprehend and follow instructions
- have a condition (other than stroke) affecting sensorimotor function
- show evidence of unilateral spatial neglect
- unable to sit in a chair without armrests for 2 hours
Data sourced from ClinicalTrials.gov (NCT05036642). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.