50 Participants NeededMy employer runs this trial

activPAL Device for Stroke

(RIsE Trial)

JR
SK
Overseen BySahra Khan, BS
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: Wake Forest University Health Sciences
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to understand how patients with severe strokes move during their hospital stay. Researchers will use a small wearable device called activPAL to track movements and compare them with usual care mobility data. The goal is to learn about typical movement patterns after a stroke and assess how well patients meet their mobility goals. This information could help improve long-term mobility treatments for stroke patients. The trial is suitable for adults hospitalized with a severe ischemic stroke who can move with assistance and do not have severe mobility limitations from other conditions. As an unphased trial, it offers patients the opportunity to contribute to research that could enhance future mobility treatments for stroke survivors.

Do I have to stop taking my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that the activPAL device is safe for stroke patients?

Research has shown that the activPAL device is generally easy to use and comfortable. This small, wearable gadget tracks movement and has undergone testing in several studies. These studies evaluated its effectiveness and ease of use for patients after a stroke.

Regarding safety, no major issues have emerged. The device has been used with various groups, including older adults, and has proven reliable in measuring activities like sitting, standing, and walking. Reports of serious side effects or discomfort from wearing it have not surfaced.

Based on the available information, the activPAL device appears safe for tracking movement in patients with severe stroke.12345

Why are researchers excited about this trial?

Researchers are excited about the use of the activPAL device for stroke patients because it offers a unique way to monitor and understand mobility patterns. Unlike traditional treatments for ischemic stroke, which often focus on medication and physical therapy, the activPAL device provides real-time data on how patients move during recovery. This can help tailor rehabilitation programs more precisely to each patient's needs, potentially improving outcomes. The device's ability to offer continuous, detailed tracking sets it apart from standard care options, offering new insights into patient mobility that could enhance recovery strategies.

What evidence suggests that the activPAL device is effective for tracking mobility in stroke patients?

Research has shown that the activPAL device effectively tracks movement, particularly in individuals who have experienced a severe stroke. In this trial, researchers will observe hospitalized adult patients with severe acute ischemic stroke using the activPAL4pro device to monitor mobility patterns during hospitalization. This small, wearable gadget records data on the quantity and quality of patient movement, including posture and limb movements. This information aids in understanding normal movement patterns and their changes during hospital stays. Analyzing this data allows healthcare providers to enhance treatment plans, ultimately improving stroke patients' mobility over time. While the device does not treat the stroke itself, it provides valuable insights that could lead to better recovery strategies.13467

Who Is on the Research Team?

RK

Rahul Karamchandani, MD

Principal Investigator

Wake Forest University Health Sciences

Are You a Good Fit for This Trial?

This trial is for adults (18+) who are hospitalized with a recent severe stroke, have significant movement or disability from the stroke, but were mostly independent before it happened.

Inclusion Criteria

I am 18 years old or older.
I am currently hospitalized for an acute ischemic stroke.
* Initial National Institutes of Health Stroke Scale (NIHSS) score of 10 or greater
See 2 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1 week

Observation

Participants are observed for mobility patterns using the activPAL4pro device and routine clinical mobility assessments during hospitalization

2 weeks
Daily monitoring

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • activPAL device

Trial Overview

The study uses a small wearable device called activPAL to track how much and how well patients move during their hospital stay after a severe stroke. This information will be compared to standard mobility data already collected in care.

How Is the Trial Designed?

1

Treatment groups

Experimental Treatment

Group I: Severe Acute Ischemic Stroke PatientsExperimental Treatment1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Wake Forest University Health Sciences

Lead Sponsor

Trials
1,432
Recruited
2,506,000+

Citations

Study Details | NCT07638462 | RIsE Stroke Mobility Study

The activPAL4pro provides data on posture, limb movement, sleep, sitting and ambulatory movement. For this reason, the activPAL4pro device will ...

activPAL Device for Stroke · Info for Participants

The study uses a small wearable device called activPAL to track how much and how well patients move during their hospital stay after a severe ...

3.

pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/10680803/

Effectiveness of t-PA in acute ischemic stroke

Results: Of 68 consecutively treated patients (with a mean baseline NIHSS score of 15 +/- 6), 26 (38%) made a full recovery and 39 (57%) made an independent ...

(PDF) Acute Hospital Admission for Stroke Is Characterised ...

Demographic and ActivPal™data are described. Results. Seventy-eight stroke survivors were recruited of whom 54 had complete data for 3 days ...

5.

palt.com

palt.com/

activPAL – Research bred, research led, est. 2001

The activPAL measures physical activities. When you move, it moves generating totals for the time spent lying, sitting, standing and stepping, every second of ...

Feasibility and Outcomes of Device and Self-Reported ...

Feasibility outcomes included proportion of the IPAQ collected, and proportion of activPAL devices returned and days of valid data. To ...

Test–retest reliability of step counts with the ActivPAL™ ...

Data loss in this study (10–13%) was higher than previously reported. Conclusions: The ActivPAL is reliable for treadmill walking, jogging and self-paced ...