search
Back to results

Evaluation of FES+VFBT With Individuals With Lived Experience

Primary Purpose

Spinal Cord Injuries, Stroke

Status
Recruiting
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
FES+VFBT
Sponsored by
University Health Network, Toronto
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Spinal Cord Injuries focused on measuring Balance, Functional Electrical Stimulation

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Individuals with a non-progressive, motor incomplete SCI/D (i.e. American Spinal Injury Association Impairment Scale (AIS) C or D) or a middle cerebral artery (MCA) stroke chronic stage of recovery (i.e. >1 year post-SCI/D or stroke), when natural recovery has plateaued ≥18 years old able to stand independently for 60 seconds moderate level of trunk control as evidenced by the ability to reach forward >2 inches in standing (i.e. score of 1-3 on the Berg Balance Scale Reaching Forward task); free of any other condition besides SCI/D or stroke that significantly affects walking or balance (e.g., no vestibular disorder, significant vision loss) able to understand spoken English Exclusion Criteria: a prior lower extremity fragility fracture an injection of botulinum toxin to leg muscles in the past two weeks or injection planned during treatment period peripheral nerve damage in the legs contraindications for FES (i.e. implanted electronic device, active cancer or radiation in past six months, uncontrolled epilepsy, skin rash/wound at an electrode site, pregnancy, active deep vein thrombosis)31 contraindications for TMS (i.e. history of epilepsy and/or seizures)

Sites / Locations

  • KITE-Toronto Rehabilitation InstituteRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

FES+VFBT

Arm Description

Functional electrical stimulation combined with visual feedback balance training

Outcomes

Primary Outcome Measures

Change in Berg Balance Scale score
Scores range from 0-56, higher score equals greater balance
Change in Activities-specific Balance Confidence Scale score
Scores range from 0-100%, higher score equals greater confidence in balance
Change in strength of the trunk and lower extremity
The force, measured in lbs or kg, of eight lower extremity muscle groups (i.e. hip extensors, hip flexors, hip abductors, hip adductors, knee extensors, knee flexors, ankle plantarflexors and ankle dorsiflexors) will be measured using a hand-held dynamometer. Scores range from 0-40, higher score equals greater strength.
Change in static standing balance
Will be assessed by measuring postural sway during quiet standing on the force sensing mat for 60 seconds under two conditions presented in a random order: eyes open and eyes closed. The amount of body sway, such as COP amplitude and speed, will be quantified to examine the change of static balance as well as reliance on the visual information.
Change in dynamic standing balance
Will be assessed by asking participants to lean as far as possible in the forward, backward and sideways directions while standing on the force sensing mat (i.e. limits of stability test). The maximum centre of pressure (COP) amplitude in the anterior, posterior and mediolateral directions will be recorded. The change of COP amplitude will be assessed. Electromyography will be recorded in the major leg muscles. The change in co-contraction and muscle synergy will be investigated to quantify the change in muscle activation pattern by the intervention.
Questionnaire on the participants' perspectives of the FES+VFBT intervention
Semi-structured interview on the participants' perspectives of the FES+VFBT intervention

Secondary Outcome Measures

Change in cutaneous pressure sensation
Monofilaments of six different thicknesses will be applied in order of descending thickness. Each monofilament will be applied six times with the participant's eyes closed. Participants will indicate when they can feel pressure being applied. Total score is the number of correct responses (maximum score of 72: 6 monofilaments x 6 applications x 2 toes).Scores range from 0-72, greater score equals greater cutaneous pressure sensation.
Change in correct proprioception responses of the first metatarso-phalangeal and ankle joints
With participants' eyes closed, the therapist will slowly move each joint through 10 degrees of range of motion in either the extension/plantarflexion or flexion/dorsiflexion directions. Participants will indicate the direction of the movement (i.e. down or up, respectively). Six movements per joint will be performed, resulting in a total possible score of 24 (6 movements x 4 joints). Scores range from 0-24, greater score equals greater proprioception.
Change of corticospinal excitability
Motor evoked potential induced by transcranial magnetic stimulation (TMS) will be measured during sitting to examine the corticospinal excitability.

Full Information

First Posted
January 18, 2023
Last Updated
April 20, 2023
Sponsor
University Health Network, Toronto
search

1. Study Identification

Unique Protocol Identification Number
NCT05744271
Brief Title
Evaluation of FES+VFBT With Individuals With Lived Experience
Official Title
Evaluation of FES+VFBT With Individuals With Lived Experience
Study Type
Interventional

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Recruiting
Study Start Date
April 1, 2023 (Actual)
Primary Completion Date
December 31, 2024 (Anticipated)
Study Completion Date
August 31, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Health Network, Toronto

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
Falls are an "emerging public health crisis" that cost the Canadian health care system billions of dollars each year. Moreover falls have a significant, detrimental impact on the lives of those who fall. In addition to physical injury and hospital admission, individuals may experience a post-fall syndrome characterized by dependence, depression, and reduced mobility and participation. Individuals living with the effects of neurological disease or injury are at a particularly high risk of falling. For example, 69-78% of individuals with spinal cord injury or disease (SCI/D) and 73% of individuals post-stroke fall at least once per year. Despite this high fall risk, evidence-based initiatives to prevent falls among those with SCI/D or stroke are lacking in neurorehabilitation. Furthermore, little time is dedicated to improving balance during inpatient neurorehabilitation. For example, ambulatory inpatients with SCI/D spend, on average, a mere 2.0±2.0 hours on balance training over the course of their entire inpatient stay. Our team is developing effective solutions to the "high-volume, high-risk and high-cost challenge" of falls. Our long-term objective is to develop an intervention that improves balance in a clinically meaningful and feasible way, facilitating the recovery of safe upright mobility and addressing the current health crisis of falls in individuals living with neurological disease or injury. The intervention will be developed with a focus on neurological populations, as these patient groups have a critical need for balance training; however, the intervention will be transferrable to other populations at risk of falls, such as older able-bodied adults. A probable solution to the gap in balance interventions is functional electrical stimulation (FES), whereby an electrical current is applied to peripheral nerves to facilitate muscle contractions. By applying the appropriate amount of electrical stimulation at the appropriate time during movement execution, the central nervous system can be re-educated, facilitating motor and functional improvements. The investigators developed a closed-loop FES system whose controller mimics the physiological control system. By combining this system with visual feedback balance training (VFBT), the investigators developed a prototype system of FES and VFBT (FES+VFBT). This intervention involves standing on a force plate with one's centre of pressure (COP) presented on a monitor. As the user moves his/her COP in response to a game, FES is delivered to the plantarflexor and dorsiflexor muscles through the device, MyndSearch.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Spinal Cord Injuries, Stroke
Keywords
Balance, Functional Electrical Stimulation

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
A single-subject design will be used, allowing each participant to be his/her own control. Repeated assessments will be taken over three periods: a baseline (i.e. no intervention), intervention, and follow-up.
Masking
None (Open Label)
Masking Description
Performance on clinical measures will be evaluated by a physical therapist who is blind to the study purpose, design, and intervention.
Allocation
N/A
Enrollment
20 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
FES+VFBT
Arm Type
Experimental
Arm Description
Functional electrical stimulation combined with visual feedback balance training
Intervention Type
Device
Intervention Name(s)
FES+VFBT
Intervention Description
Standing balance training with the FES+VFBT system will occur 3x/week for six weeks (i.e. 18 sessions). Electrodes will be placed on the participants' plantarflexors and dorsiflexors bilaterally and FES will be administered using the device, MyndSearch, during the balance training exercises. Each session will last one hour, including 15 min to identify motor thresholds and maximum tolerable stimulation levels, 5 min to don/doff the safety harness, 5 min to calibrate the FES+VFBT exercises, 20 min to complete the FES+VFBT exercises, and 10-15 min to take rest breaks between exercises as needed.
Primary Outcome Measure Information:
Title
Change in Berg Balance Scale score
Description
Scores range from 0-56, higher score equals greater balance
Time Frame
Baseline, after three weeks of the intervention, immediately after the intervention, 6-week follow-up after the intervention, 12-week follow-up after the intervention
Title
Change in Activities-specific Balance Confidence Scale score
Description
Scores range from 0-100%, higher score equals greater confidence in balance
Time Frame
Baseline, after three weeks of the intervention, immediately after the intervention, 6-week follow-up after the intervention, 12-week follow-up after the intervention
Title
Change in strength of the trunk and lower extremity
Description
The force, measured in lbs or kg, of eight lower extremity muscle groups (i.e. hip extensors, hip flexors, hip abductors, hip adductors, knee extensors, knee flexors, ankle plantarflexors and ankle dorsiflexors) will be measured using a hand-held dynamometer. Scores range from 0-40, higher score equals greater strength.
Time Frame
Baseline, after three weeks of the intervention, immediately after the intervention, 6-week follow-up after the intervention, 12-week follow-up after the intervention
Title
Change in static standing balance
Description
Will be assessed by measuring postural sway during quiet standing on the force sensing mat for 60 seconds under two conditions presented in a random order: eyes open and eyes closed. The amount of body sway, such as COP amplitude and speed, will be quantified to examine the change of static balance as well as reliance on the visual information.
Time Frame
Baseline, after three weeks of the intervention, immediately after the intervention, 6-week follow-up after the intervention, 12-week follow-up after the intervention
Title
Change in dynamic standing balance
Description
Will be assessed by asking participants to lean as far as possible in the forward, backward and sideways directions while standing on the force sensing mat (i.e. limits of stability test). The maximum centre of pressure (COP) amplitude in the anterior, posterior and mediolateral directions will be recorded. The change of COP amplitude will be assessed. Electromyography will be recorded in the major leg muscles. The change in co-contraction and muscle synergy will be investigated to quantify the change in muscle activation pattern by the intervention.
Time Frame
Baseline, after three weeks of the intervention, immediately after the intervention, 6-week follow-up after the intervention, 12-week follow-up after the intervention
Title
Questionnaire on the participants' perspectives of the FES+VFBT intervention
Time Frame
Immediately after the intervention
Title
Semi-structured interview on the participants' perspectives of the FES+VFBT intervention
Time Frame
Immediately after the intervention
Secondary Outcome Measure Information:
Title
Change in cutaneous pressure sensation
Description
Monofilaments of six different thicknesses will be applied in order of descending thickness. Each monofilament will be applied six times with the participant's eyes closed. Participants will indicate when they can feel pressure being applied. Total score is the number of correct responses (maximum score of 72: 6 monofilaments x 6 applications x 2 toes).Scores range from 0-72, greater score equals greater cutaneous pressure sensation.
Time Frame
Baseline, after three weeks of the intervention, immediately after the intervention, 6-week follow-up after the intervention, 12-week follow-up after the intervention
Title
Change in correct proprioception responses of the first metatarso-phalangeal and ankle joints
Description
With participants' eyes closed, the therapist will slowly move each joint through 10 degrees of range of motion in either the extension/plantarflexion or flexion/dorsiflexion directions. Participants will indicate the direction of the movement (i.e. down or up, respectively). Six movements per joint will be performed, resulting in a total possible score of 24 (6 movements x 4 joints). Scores range from 0-24, greater score equals greater proprioception.
Time Frame
Baseline, after three weeks of the intervention, immediately after the intervention, 6-week follow-up after the intervention, 12-week follow-up after the intervention
Title
Change of corticospinal excitability
Description
Motor evoked potential induced by transcranial magnetic stimulation (TMS) will be measured during sitting to examine the corticospinal excitability.
Time Frame
Baseline, after three weeks of the intervention, immediately after the intervention, 6-week follow-up after the intervention, 12-week follow-up after the intervention

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Individuals with a non-progressive, motor incomplete SCI/D (i.e. American Spinal Injury Association Impairment Scale (AIS) C or D) or a middle cerebral artery (MCA) stroke chronic stage of recovery (i.e. >1 year post-SCI/D or stroke), when natural recovery has plateaued ≥18 years old able to stand independently for 60 seconds moderate level of trunk control as evidenced by the ability to reach forward >2 inches in standing (i.e. score of 1-3 on the Berg Balance Scale Reaching Forward task); free of any other condition besides SCI/D or stroke that significantly affects walking or balance (e.g., no vestibular disorder, significant vision loss) able to understand spoken English Exclusion Criteria: a prior lower extremity fragility fracture an injection of botulinum toxin to leg muscles in the past two weeks or injection planned during treatment period peripheral nerve damage in the legs contraindications for FES (i.e. implanted electronic device, active cancer or radiation in past six months, uncontrolled epilepsy, skin rash/wound at an electrode site, pregnancy, active deep vein thrombosis)31 contraindications for TMS (i.e. history of epilepsy and/or seizures)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Kristin E Musselman, PhD
Phone
4165973422
Ext
6190
Email
kristin.musselman@uhn.ca
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kristin E Musselman, PhD
Organizational Affiliation
KITE-Toronto Rehabilitation Institute, UHN
Official's Role
Principal Investigator
Facility Information:
Facility Name
KITE-Toronto Rehabilitation Institute
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M4G 3V9
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kristin E Musselman, PhD
Phone
416-597-3422
Ext
6190
Email
kristin.musselman@uhn.ca

12. IPD Sharing Statement

Learn more about this trial

Evaluation of FES+VFBT With Individuals With Lived Experience

We'll reach out to this number within 24 hrs