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Completed

NCT Number: NCT04262414

Restoring Upright Mobility After Spinal Cord Injury

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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Key information

Conditions

Spinal Cord Injuries Central Nervous System Diseases Nervous System Diseases Spinal Cord Diseases Trauma, Nervous System Wounds and Injuries

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Lyndhurst Centre, Toronto Rehabilitation Institute-UHN

Toronto, Ontario, M4G 3V9, Canada

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • A traumatic or non-traumatic, non-progressive (AIS) C or D SCI;
  • ≥18 years old;
  • Able to stand independently for 60s;
  • Moderate level of trunk control as evidenced by the ability to reach forward >2 inches in standing (i.e. score of 2 on the BBS Reaching Forward task50,51); and
  • Free of any other condition besides SCI that significantly affects walking or balance (e.g., no vestibular disorder, significant vision loss, stroke).

Exclusion criteria

  • Severe spasticity in the legs;
  • Contractures in the lower extremities that prevent achieving a neutral hip and ankle position, or extended knee;
  • A prior lower extremity fragility fracture;
  • An injection of botulinum toxin to leg muscles in the past six months;
  • Peripheral nerve damage in the legs (i.e. leg muscles unresponsive to electrical stimulation);
  • A pressure sore (>grade 2) on the pelvis or trunk where the safety harness is applied; o
  • Contraindications for FES52 (i.e. implanted electronic device, active cancer or radiation in past 6 months, epilepsy, skin rash/wound at a potential electrode site).

Participants will be withdrawn from the study if FES irritates their skin.

Treatment and study plan

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.

Primary outcomes

  1. Berg Balance Scale

    Time frame: Change from Baseline Berg Balance Scale at 8 weeks

    Assesses static and dynamic standing balance; score 0-56; higher score means a better outcome

  2. Mini-Balance Evaluation Systems Test

    Time frame: Change from Baseline Mini-Balance Evaluation Systems Test at 8 weeks

    Assesses four balance control systems, including anticipatory balance, reactive postural control, sensory orientation and dynamic gait

  3. Activities-specific Balance Confidence Scale

    Time frame: Change from Baseline Activities-specific Balance Confidence Scale at 8 weeks

    A measure of balance self-efficacy; mean score of 0-100; higher score means a better outcome (i.e. high balance confidence)

Secondary outcomes

  1. Static standing balance

    Time frame: Through study completion, average of 8 weeks

    Postural sway during quiet standing

  2. Dynamic standing balance

    Time frame: Through study completion, average of 8 weeks

    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)

  3. Semi-structured interview

    Time frame: up to 8 weeks post-intervention

    The guide will include open-ended questions concerning the participant's experience with, and impressions of, A-FES therapy

Sponsors and collaborators

Lead sponsor

University Health Network, Toronto

Other

Registry information

Official study title

Restoring Upright Mobility After Spinal Cord Injury Using Functional Electrical Stimulation

Important dates

Study start
2017
Primary completion
2018
Study completion
2019
First posted
Feb 10, 2020
Registry last updated
May 23, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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