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Behavioural Intervention

Balance Training + Electrical Stimulation for Spinal Cord Injury

N/A
Waitlist Available
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)
Must not have
Participant presents with other conditions besides iSCI that affect balance (e.g. vestibular disorder, brain injury)
Participant has a history of a lower limb fragility fracture
Timeline
Screening 3 weeks
Treatment Varies
Follow Up change from baseline to 6-month follow-up
Awards & highlights
No Placebo-Only Group

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.
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.
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 below
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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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have conditions like a vestibular disorder or brain injury that affect my balance besides iSCI.
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I have had a fracture in my leg due to weak bones.
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I have a severe skin injury on my pelvis, trunk, or foot.
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I do not have an implanted electronic device, recent radiation, active DVT, or am not pregnant.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~change from baseline to 6-month follow-up
This trial's timeline: 3 weeks for screening, Varies for treatment, and change from baseline to 6-month follow-up for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Isometric strength
Lean-and-Release Test
Proprioception of the ankle joints
+1 more

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial 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
1,526 Previous Clinical Trials
503,225 Total Patients Enrolled
Kristin E Musselman, PhDPrincipal InvestigatorUniversity Health Network, Toronto
3 Previous Clinical Trials
45 Total Patients Enrolled

Media Library

Reactive Balance Training (Behavioural Intervention) Clinical Trial Eligibility Overview. Trial Name: NCT04881565 — N/A
Spinal Cord Injury Research Study Groups: Reactive balance training, Reactive balance training plus functional electrical stimulation
Spinal Cord Injury Clinical Trial 2023: Reactive Balance Training Highlights & Side Effects. Trial Name: NCT04881565 — N/A
Reactive Balance Training (Behavioural Intervention) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04881565 — N/A
~0 spots leftby Dec 2024
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