N/A
N=10
Exercise-primed Upper Extremity Motor Practice in Chronic Stroke
Stroke
Bottom Line
View on ClinicalTrials.gov: NCT04259424 ↗Enrolled (actual)
10
Serious AEs
0.0%
Results posted
May 2023
Primary outcome: Primary: Change in Upper Extremity Impairment as Assessed by the Fugl-Meyer Assessment - Upper Extremity — 2.6 units on a scale — p=.15
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Aerobic Exercise + Duck Duck Punch (Device)
- Age
- Adult, Older Adult · 21+ yrs
- Sex
- All
- Sponsor
- Medical University of South Carolina
- Primary completion
- Mar 2022
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Upper Extremity Impairment as Assessed by the Fugl-Meyer Assessment - Upper Extremity |
2.6 | .15 |
| SECONDARY Change in Upper Extremity as Assessed by the Wolf Motor Function Test |
.1 | — |
| SECONDARY Change in Physical Function and Health-related Quality of Life as Assessed by Stroke Impact Scale |
8.5; -0.5 | — |
Summary
The purpose of this project is to establish initial feasibility and tolerability of a combined aerobic exercise (AEx) and upper extremity motor practice intervention on upper extremity (UE) function in chronic stroke survivors. This novel intervention pairs AEx with a virtual reality-based upper extremity rehabilitation game, Duck Duck Punch (DDP). AEx has been shown to improve overall brain function and promote a healthy brain environment; thus it may serve as an effective 'primer' and enhance the effects of DDP. Movement-based priming for rehabilitation involves performing movement or exercise before, or simultaneous to, an intervention with the goal of improving the effectiveness of the intervention. AEx combined with UE rehabilitation can improve UE function and self-reported health status in chronic stroke survivors. However, gaps remain regarding the clinical applicability of an AEx priming session and the mechanisms contributing to changes in UE functions in response to AEx-primed UE rehabilitation. Therefore, the aim of this project is to: 1) demonstrate the feasibility of pairing AEx + DDP in stroke survivors; 2) quantify the magnitude of the effect of the AEx + DDP intervention on UE function; 3) examine relationship of biomarkers of the nervous system and response to AEx + DDP.
Eligibility Criteria
Inclusion Criteria
- experienced unilateral stroke at least 6 months, but no more than 120 months prior
- voluntary shoulder flexion of the affected arm ≥20° with simultaneous elbow extension ≥10°
- moderate arm movement impairment (UE Fugl-Meyer Assessment > 21 but 200 mmHg and diastolic >110 mmHg at rest
- history of, or current, depression and for brain stimulation procedures only
- women of child-bearing potential
- electronic or metallic implants
- history of seizures
Data sourced from ClinicalTrials.gov (NCT04259424). 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.