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Up to 15 able-bodied individuals will participate in one testing session to evaluate the effectiveness of the A-FES system. Up to 20 individuals with SCI will participate in 12 sessions of A-FES therapy. At each session, participants will stand on a force plate (Accu Sway, AMTI, USA) with the A-FES system (Compex Motion II, Compex Motion, Switzerland) donned. The centre of pressure (COP) will be calculated in real time using the force plate data. The calculated COP will be presented to participants on a monitor and they will be instructed to shift their COP in the indicated directions as represented by a cursor (i.e. training with visual feedback). The intensity of electrical stimulation provided by the A-FES system will be regulated by the measured COP in a closed-loop manner. In this study we propose to develop and evaluate the clinically-feasible A-FES system for the training of standing balance.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Functional Electrical Stimulation | Device | The device used was a prototype closed-loop FES system to improve standing balance by activating the ankle plantar flexors and dorsiflexors (i.e. A-FES system). As a closed-loop system, the body's position and velocity are continually monitored, and the level of stimulation adjusted accordingly on a moment-to-moment basis. This differs from currently available FES units, which do not monitor body movement and therefore, provide a constant level of stimulation unless manually adjusted by the user/PT. The control strategy used in the A-FES system mimics the physiological control system in able-bodied people, meaning it has the potential to "re-educate" normal movement patterns. |
| Measure | Description | Time Frame |
|---|---|---|
| Berg Balance Scale | Assesses static and dynamic standing balance; score 0-56; higher score means a better outcome | Change from Baseline Berg Balance Scale at 8 weeks |
| Mini-Balance Evaluation Systems Test | Assesses four balance control systems, including anticipatory balance, reactive postural control, sensory orientation and dynamic gait | Change from Baseline Mini-Balance Evaluation Systems Test at 8 weeks |
| Activities-specific Balance Confidence Scale | A measure of balance self-efficacy; mean score of 0-100; higher score means a better outcome (i.e. high balance confidence) | Change from Baseline Activities-specific Balance Confidence Scale at 8 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Static standing balance | Postural sway during quiet standing | Through study completion, average of 8 weeks |
| Dynamic standing balance | Assessed by asking participants to lean as far as possible in the forward, backward and sideways directions while standing on a force plate (i.e. limits of stability test) |
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Inclusion Criteria:
Exclusion Criteria:
Participants will be withdrawn from the study if FES irritates their skin.
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| Name | Affiliation | Role |
|---|---|---|
| Kristin E Musselman, PhD | University of Toronto | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Lyndhurst Centre, Toronto Rehabilitation Institute-UHN | Toronto | Ontario | M4G 3V9 | Canada |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33794948 | Derived | Houston DJ, Unger J, Lee JW, Masani K, Musselman KE. Perspectives of individuals with chronic spinal cord injury following novel balance training involving functional electrical stimulation with visual feedback: a qualitative exploratory study. J Neuroeng Rehabil. 2021 Apr 1;18(1):57. doi: 10.1186/s12984-021-00861-z. |
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| ID | Term |
|---|---|
| D013119 | Spinal Cord Injuries |
| D013118 | Spinal Cord Diseases |
| ID | Term |
|---|---|
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D020196 | Trauma, Nervous System |
| D014947 | Wounds and Injuries |
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| Through study completion, average of 8 weeks |
| Semi-structured interview | The guide will include open-ended questions concerning the participant's experience with, and impressions of, A-FES therapy | up to 8 weeks post-intervention |