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Behavioural Intervention
Balance Training + Electrical Stimulation for Spinal Cord Injury
N/A
Recruiting
Led By Kristin E Musselman, PhD
Research Sponsored by University Health Network, Toronto
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Participant requires physical assistance, a gait aid or a brace to ambulate 10 meters (i.e. self-selected score of 1-19 on the Walking Index for Spinal Cord Injury (WISCI) II)
Participant is able to stand for >30 seconds without upper limb support or assistance (i.e. scores 2/4 on item two of the Berg Balance Scale, Standing Unsupported)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up change from baseline to 6-month follow-up
Awards & highlights
Study Summary
This trial will test the efficacy of a modified balance training that includes electrical stimulation for people with incomplete spinal cord injuries, who are at high risk for falls.
Who is the study for?
This trial is for adults over 18 with chronic motor spinal cord injury at T12 or above, who can stand unassisted for more than 30 seconds and need help to walk. They must be able to attend three sessions a week for six weeks but cannot join if they have lower limb fractures, conditions affecting balance other than iSCI, certain contraindications to electrical stimulation, or severe pressure injuries.Check my eligibility
What is being tested?
The study tests reactive balance training (RBT) combined with functional electrical stimulation (RBT+FES) against RBT alone in preventing falls among those with incomplete spinal cord injury. Participants will undergo training thrice weekly for six weeks and their balance, strength, proprioception and fall frequency will be assessed before, after and six months post-training.See study design
What are the potential side effects?
Potential side effects may include discomfort from the functional electrical stimulation (FES), skin irritation where devices are attached or harnesses worn during training sessions. The exact side effects aren't detailed but could relate to physical exertion involved in the balance training.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I need help or a device to walk 10 meters.
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I can stand for more than 30 seconds without help.
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I had a spinal cord injury above T12 and can move some muscles.
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I am 18 years old or older.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ change from baseline to 6-month follow-up
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~change from baseline to 6-month follow-up
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Activities-specific Balance Confidence Scale
Berg Balance Scale
Falls Efficacy Scale - International
+5 moreTrial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Reactive balance training plus functional electrical stimulationExperimental Treatment1 Intervention
Group II: Reactive balance trainingActive Control1 Intervention
Find a Location
Who is running the clinical trial?
University Health Network, TorontoLead Sponsor
1,466 Previous Clinical Trials
484,334 Total Patients Enrolled
Kristin E Musselman, PhDPrincipal InvestigatorUniversity Health Network, Toronto
3 Previous Clinical Trials
45 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have conditions like a vestibular disorder or brain injury that affect my balance besides iSCI.I need help or a device to walk 10 meters.I have had a fracture in my leg due to weak bones.I can stand for more than 30 seconds without help.My injury happened over a year ago.I do not have an implanted electronic device, recent radiation, active DVT, or am not pregnant.I have a severe skin injury on my pelvis, trunk, or foot.I can attend three training sessions a week for six weeks.I had a spinal cord injury above T12 and can move some muscles.I am 18 years old or older.
Research Study Groups:
This trial has the following groups:- Group 1: Reactive balance training
- Group 2: Reactive balance training plus functional electrical stimulation
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 new volunteers being accepted for this clinical trial?
"From what is published on clinicaltrials.gov, this trial is still open and looking for participants. The trial was initially posted on September 27th, 2021 and has not been updated since."
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