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Exoskeleton
Backward Gait Training for Stroke Rehabilitation
N/A
Recruiting
Led By Soo Yeon Sun
Research Sponsored by Alvernia University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
18 years of age or older
Diagnosis of first stroke (intracerebral hemorrhage or acute ischemic stroke)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline
Awards & highlights
Study Summary
This trial will investigate the effect of using a robotic exoskeleton for backward gait training on motor function and depression in adults who have had a cerebrovascular accident (stroke).
Who is the study for?
Adults who've had their first stroke and are referred to outpatient PT at Reading Rehabilitation Hospital can join. They must be over 18, able to understand English or Spanish, and follow simple commands. People with severe physical limitations like amputations, extreme spasticity, heart disease, or those too heavy for the exoskeleton cannot participate.Check my eligibility
What is being tested?
The study tests how walking backward with a robotic suit (EksoNR) affects motor function and depression in stroke survivors. It also looks at whether social factors and depression influence sticking with physical therapy.See study design
What are the potential side effects?
Potential side effects may include discomfort from wearing the exoskeleton, skin issues where it touches the body, muscle fatigue due to training exercises, and possible balance problems during use.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am 18 years old or older.
Select...
I have had one stroke, either a bleed or a clot in the brain.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ during the intervention
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~during the intervention
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Changes in Berg Balance Scale
Changes in Functional Ambulation Category
Changes in Patient Health Questionnaire-9
+3 moreOther outcome measures
Adherence to physical therapy
Educational attainment
Language spoken at home
+2 moreTrial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Standard Care with Ekso and Backward Walking GroupExperimental Treatment2 Interventions
Participants in the SCBWG (n=31) will attend two 45-minute treatment sessions per week for a minimum of 8 and a maximum of 10 total sessions. Once a week, each participant will receive standard care as described in the standard care with Ekso group.Once a week, each participant will receive backward walking training with EksoNR during their treatment session.
Group II: Standard Care with Ekso GroupActive Control1 Intervention
Participants in the SCG (n=31) will attend two 45-minute treatment sessions per week for a minimum of 8 and a maximum of 10 total sessions. For each participant, an individualized plan of care consistent with evidence-based practice standards will be provided based on rehabilitation goals. The interventions during each treatment session will include forward gait training with EksoNR, neuromuscular movement-related tasks, mobility tasks, and interventions using products and technology, and education for caregivers, family, and friends.
Find a Location
Who is running the clinical trial?
Alvernia UniversityLead Sponsor
3 Previous Clinical Trials
98 Total Patients Enrolled
The Reading Hospital and Medical CenterOTHER
13 Previous Clinical Trials
1,474 Total Patients Enrolled
Soo Yeon SunPrincipal InvestigatorAlvernia University
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have a colostomy.I have bone growth in my muscles or tendons that affects my leg movement.Your skin in contact with the EksoNRTM is not healthy.I speak English or Spanish.I am referred to the Reading Rehab Hospital for outpatient physical therapy.I have an ongoing deep vein clot.I am 18 years old or older.I have severe stiffness in my arms or legs.You have mental or thinking problems that could make it hard to use the exoskeleton.I do not have severe heart disease.I cannot stand for more than a minute due to pain or dizziness.I cannot walk even with help.I cannot follow simple instructions.I use a lower limb prosthesis or have had a lower limb amputation.I have had one stroke, either a bleed or a clot in the brain.I weigh more than 220 pounds.I have movement restrictions that affect my normal walking.I am shorter than 5'0" or taller than 6'4".My balance score is above 42.I have severe muscle stiffness.I have an unstable spine or fractures in my pelvis/limbs that haven't healed.I can't move my ankle upwards when my knee is slightly bent.My upper leg is over 0.5 inches longer than the other, or my lower leg is over 0.75 inches longer.
Research Study Groups:
This trial has the following groups:- Group 1: Standard Care with Ekso Group
- Group 2: Standard Care with Ekso and Backward Walking Group
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.
Are there still patient vacancies available for this experimental research?
"Yes, the details revealed on clinicaltrials.gov indicate that this medical trial is actively recruiting participants since its initial posting date of August 25th 2022 and last update on August 29th 2022. The study requires 62 patients to be recruited from 1 healthcare institution."
Answered by AI
What is the current quota for participants in this medical experiment?
"Affirmative. The information hosted on clinicaltrials.gov affirms that this experiment is presently recruiting participants, having originally been posted on the 25th of August 2022 and edited most recently 4 days later. 62 people are required to be enrolled at one medical location in total."
Answered by AI
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