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Behavioural Intervention
Body Weight Support with Balance Training for Balance Impairment
N/A
Waitlist Available
Led By Pete Grevelding, MSPT
Research Sponsored by Gaylord Hospital, Inc
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up the highest perturbation level achieved by the participant achieved will be recorded immediately after each intervention session.
Awards & highlights
Study Summary
This trial is testing if a robotic body weight support system is more effective in improving postural control when balance perturbations are induced during therapy sessions, compared to the system without perturbations.
Who is the study for?
This trial is for adults who've had a stroke and are in rehab, can walk with moderate fall risk or better, understand consent forms (with translation if needed), weigh under 450 pounds, and can do up to six half-hour therapy sessions using the ZeroG body weight support system.Check my eligibility
What is being tested?
The study tests whether adding balance challenges while patients use the ZeroG body weight support system improves their posture control more than just walking with the system alone. Participants will be randomly assigned to one of two groups and undergo several therapy sessions.See study design
What are the potential side effects?
Since this trial involves physical therapy exercises rather than medication, side effects may include muscle soreness or fatigue from the activities. The harness system should prevent falls but might cause discomfort at points where it supports the body.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ the care tool will be administered within 48 hours before discharge.
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~the care tool will be administered within 48 hours before discharge.
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
10 Meter Walk Test (10MWT) Post-intervention Scores
10 Meter Walk Test (10MWT) Pre-intervention Scores
Activities Specific Balance Scale (ABC) Post-intervention Scores
+3 moreSecondary outcome measures
Continuity Assessment Record and Evaluation (CARE) Self-Care Admission Scores
Continuity Assessment Record and Evaluation (CARE) Self-Care Discharge Scores
Continuity Assessment Record and Evaluation (CARE) Tool Mobility Admission Scores
+2 moreTrial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Body weight support system with balance perturbationsExperimental Treatment1 Intervention
The BWSS with balance perturbations (BWSS-P) experimental intervention group will also conduct 2 to 6, 30 minute sessions, over two-weeks. Participants in the BWSS-P group will conduct the same balance and gait exercises as the control group, including: marching, side-stepping, retro-ambulation, step-taps, step-ups, ambulation over the ground, going up and down stairs, and performing sit-to-stand transitions. However, each sessions will include eight, resistive or assistive, balance perturbations, two in each cardinal direction (lateral, anterior, and posterior).
Group II: Body weight support system control groupActive Control1 Intervention
The Body weight support system (BWSS) active comparator control group will conduct 2 to 6, 30 minute sessions, over two-weeks. To be as pragmatic and clinically relevant as possible, treatment sessions will be incorporated directly to the participants' normal care. Furthermore, participants are allowed to complete 2 to 6 sessions as dictated by short or unexpected changes to the discharge planning timeline. During each session, participants will conduct balance exercises, including: marching, side-stepping, retro-ambulation, step-taps, and step-ups. Participants will also conduct various standard gait exercises, including: ambulation over the ground, going up and down stairs, and performing sit-to-stand transitions.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Body weight support system with balance perturbations
2019
N/A
~40
Find a Location
Who is running the clinical trial?
Gaylord Hospital, IncLead Sponsor
6 Previous Clinical Trials
192 Total Patients Enrolled
2 Trials studying Stroke
62 Patients Enrolled for Stroke
Medstar Health Research InstituteOTHER
189 Previous Clinical Trials
115,447 Total Patients Enrolled
5 Trials studying Stroke
3,592 Patients Enrolled for Stroke
St. Luke's Rehabilitation InstituteOTHER
3 Previous Clinical Trials
198 Total Patients Enrolled
1 Trials studying Stroke
52 Patients Enrolled for Stroke
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You have seizures that are happening often.You have had spine stabilization using halos.Your blood pressure is not well controlled, either too high or too low.You have unstable skin structures, such as skin grafts.Recent removal of a limb.You have a balance problem related to the inner ear.Conditions you had before that might affect your balance.You currently have issues with standing up without feeling dizzy or lightheaded.You have a good balance, as shown by a score of 21 or higher on the Berg Balance Scale.Patients who have a Barthel Index score of 21 or higher and are expected to stay in the hospital for 10 days or more may be asked to join the study.You have normal thinking and memory skills.You weigh more than 450 pounds, which is too heavy for the ZeroG system to support.This criterion is too brief for me to rewrite clearly. Can you please provide more context or clarify what you are asking for?You have recently broken ribs or bones in your legs.You have very severe osteoporosis.Participants who should not have pressure applied to their abdomen, thighs, groin, or shoulders.You have trouble understanding and making decisions about the study.You need more than 50% high flow oxygen according to hospital treatment guidelines.
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
What are the desired outcomes of this research endeavor?
"The primary purpose of this clinical trial, to be evaluated through the Activities Specific Balance Scale upon consent, is to assess pre-intervention Berg Balance Scale scores. Supporting objectives include Continuity Assessment Record and Evaluation (CARE) Mobility Discharge Scores on a 1-6 scale with higher numbers suggesting greater autonomy; CARE Self Care Admission Scores measured similarly; and finally, CARE Tool Mobility Admission Scores which will also contrast patients' dependence levels numerically."
Answered by AI
Are there multiple sites participating in this scientific investigation within the state?
"Currently, this clinical trial is running in 4 different locations such as Providence St. Luke's Rehabilitation Medical Center in Spokane, Gaylord Hospital in Wallingford, and MedStar National Rehabilitation Hospital in Washington that are being supplemented by other sites."
Answered by AI
Are any individuals currently being enrolled in this research endeavor?
"Data published on clinicaltrials.gov affirms that the trial is not presently recruiting patients, having first been posted in December 2021 and most recently edited in November 2022. However, 1226 other medical studies are now open for enrolment."
Answered by AI
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