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Rehabilitation Exercises for Stroke Recovery (Boost Trial)

Q: Is the elderly population being considered for this trial?

This clinical trial has set the age of eligibility between 18 and 84. Qualified minors can apply for 39 different studies, while 1131 trials are available to seniors over 65 years old.

Q: How many participants is this study recruiting?

Affirmative. As outlined on clinicaltrials.gov, this medical trial which originated on August 1st 2023 is still actively enrolling patients and the last edit was made on November 16th of the same year. The research aims to recruit 60 individuals from 3 distinct sites.

Q: Is it possible to enroll in this clinical exploration at present?

Correct. According to the details available on clinicaltrials.gov, this medical study commenced recruitment on August 1st 2023 and was last updated November 16th 2023. The team aim to enroll roughly 60 patients from 3 different locations.

Q: To which demographic is this clinical trial open?

This research is recruiting sixty <a href="https://www.withpower.com/clinical-trials/stroke">stroke</a> victims from the ages of eighteen to eighty-four. Applicants should not have experienced a stroke in the past three weeks, possess a UE Fugl-Meyer Motor Score lower than 42/66, lack severe shoulder <a href="https://www.withpower.com/clinical-trials/pain">pain</a> while using wheelchairs (rated less than 6 on visual analog scales), demonstrate minimal spasticity at their affected upper extremity (scored below 4 with Modified Ashworth Scales) and be able to sit comfortably in a wheelchair for at least half an hour prior to acceptance into Acute Rehabilitation programs.

N/A

Recruiting

Led By Emily Rosario, PhD

Research Sponsored by University of California, Irvine

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Experienced a single stroke or multiple strokes >3 days and < 3 weeks prior to study enrollment, and currently admitted or accepted into Acute Rehabilitation program for stroke.

Absence of severe tone at the affected UE (score <4 on the Modified Ashworth Spasticity Scale)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline upon admission (assessed within 3 days upon admission), post-intervention evaluation at discharge (assessed within 3 days before discharge), and 3-month post-stroke evaluation (assessed within 3 days before or after 3-month post stroke date)

Awards & highlights

Boost Trial Summary

This trial will compare two arm exercises during rehab to measure their effects on arm function. One is custom exercises by a therapist and the other involves moving the arm in a wheelchair.

Who is the study for?

This trial is for stroke survivors aged 18-84, within 3 days to 3 weeks post-stroke, admitted into an Acute Rehabilitation program. They should have a certain level of arm motor function (Fugl-Meyer score <42), be able to sit in a wheelchair, and not suffer from severe pain or muscle stiffness in the affected arm.Check my eligibility

What is being tested?

The study measures how effective two additional arm exercise methods are compared to standard rehab exercises. One method uses customized hand and arm exercises designed by therapists; the other involves using a moveable wheelchair armrest called Boost.See study design

What are the potential side effects?

There may be minimal side effects such as mild discomfort or fatigue due to increased physical activity during rehabilitation exercises. However, individuals with moderate to severe shoulder pain or high muscle tone were excluded to minimize risks.

Boost Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I had a stroke between 3 days and 3 weeks ago and am now in a rehab program for it.

Select...

My arm stiffness is mild (score less than 4 on a spasticity scale).

Select...

I don't have severe shoulder pain when using a wheelchair armrest (<6/10 pain).

Select...

I am between 18 and 84 years old.

Boost Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline upon admission (assessed within 3 days upon admission), post-intervention evaluation at discharge (assessed within 3 days before discharge) , and 3-month post-stroke evaluation (assessed within 3 days before or after 3-month post stroke date)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline upon admission (assessed within 3 days upon admission), post-intervention evaluation at discharge (assessed within 3 days before discharge) , and 3-month post-stroke evaluation (assessed within 3 days before or after 3-month post stroke date)

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline upon admission (assessed within 3 days upon admission), post-intervention evaluation at discharge (assessed within 3 days before discharge) , and 3-month post-stroke evaluation (assessed within 3 days before or after 3-month post stroke date) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Fugl-Meyer Arm Motor Assessment Score (FMAMA)

Secondary outcome measures

Box and Blocks Test

Modified Ashworth Spasticity Scale

Shoulder subluxation Distance

Boost Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Boost - Moveable wheelchair Arm restExperimental Treatment1 Intervention

Movable wheelchair arm rest device group: participants in this group will be provided with a wheelchair equipped with movable wheelchair arm rest device and will be trained by training therapists on how to use the device. Therapists will determine if the participant is capable of using the device in either a stationary mode or overground mode. Afterwards, participants will be allowed to utilize the device within the inpatient facility on their own. The investigators encourage at least 30 minutes per day of device use, although this is not required or limited to 30 minutes. Therapists may adjust the difficulty of the device utilize to provide additional challenge as they deem suitable for the participant. Once participants are discharged from the unit, they will be allowed to keep the movable wheelchair arm rest devices until their 3-month post stroke follow up visit, the last visit of the study.

Group II: Electronic Arm ExercisesActive Control1 Intervention

Electronic exercise program designed by training therapists. These exercises will be assigned to the participants electronically using a commercial home exercise program platform commonly used by hospital systems (i.e.: Medbridge). They will be encouraged to exercise for 30 min/day in addition to the regular rehabilitation therapy at Acute Rehab Unit (ARU), although this is not required or limited to 30 minutes. Therapists may adjust the difficulty of exercise program to provide additional challenge as they deem suitable for the participant. Once participants are discharged from the unit, they will be allowed to keep the electronic exercise program until their 3-month post stroke follow up visit, the last visit of the study.

0 / 4Eligibility criteria met

Find a Location

Who is running the clinical trial?

Casa Colina Hospital and Centers for HealthcareOTHER

9 Previous Clinical Trials

241 Total Patients Enrolled

5 Trials studying Stroke

159 Patients Enrolled for Stroke

University of California, IrvineLead Sponsor

544 Previous Clinical Trials

1,922,983 Total Patients Enrolled

19 Trials studying Stroke

1,787 Patients Enrolled for Stroke

Flint Rehabilitation Devices, LLCIndustry Sponsor

5 Previous Clinical Trials

126 Total Patients Enrolled

2 Trials studying Stroke

77 Patients Enrolled for Stroke

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is the elderly population being considered for this trial?

"This clinical trial has set the age of eligibility between 18 and 84. Qualified minors can apply for 39 different studies, while 1131 trials are available to seniors over 65 years old."

Answered by AI

How many participants is this study recruiting?

"Affirmative. As outlined on clinicaltrials.gov, this medical trial which originated on August 1st 2023 is still actively enrolling patients and the last edit was made on November 16th of the same year. The research aims to recruit 60 individuals from 3 distinct sites."

Answered by AI

Is it possible to enroll in this clinical exploration at present?

"Correct. According to the details available on clinicaltrials.gov, this medical study commenced recruitment on August 1st 2023 and was last updated November 16th 2023. The team aim to enroll roughly 60 patients from 3 different locations."

Answered by AI

To which demographic is this clinical trial open?

"This research is recruiting sixty stroke victims from the ages of eighteen to eighty-four. Applicants should not have experienced a stroke in the past three weeks, possess a UE Fugl-Meyer Motor Score lower than 42/66, lack severe shoulder pain while using wheelchairs (rated less than 6 on visual analog scales), demonstrate minimal spasticity at their affected upper extremity (scored below 4 with Modified Ashworth Scales) and be able to sit comfortably in a wheelchair for at least half an hour prior to acceptance into Acute Rehabilitation programs."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Comparing Different Rehabilitation Exercise Strategies for Improving Arm Recovery After Stroke

An Do 2023. "Comparing Different Rehabilitation Exercise Strategies for Improving Arm Recovery After Stroke". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05880940.