Restoring Upright Mobility After Spinal Cord Injury

Restoring Upright Mobility After Spinal Cord Injury Using Functional Electrical Stimulation

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.

Study Overview

• Status: Completed
• Conditions: Spinal Cord Diseases; Spinal Cord Injuries
• Intervention / Treatment: Device: Functional Electrical Stimulation

• Study Type: Interventional
• Enrollment (Actual): 5
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Canada
  • Ontario
    • Toronto, Ontario, Canada, M4G 3V9
      • Lyndhurst Centre, Toronto Rehabilitation Institute-UHN

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. A traumatic or non-traumatic, non-progressive (AIS) C or D SCI;
2. ≥18 years old;
3. Able to stand independently for 60s;
4. 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
5. Free of any other condition besides SCI that significantly affects walking or balance (e.g., no vestibular disorder, significant vision loss, stroke).

Exclusion Criteria:

1. Severe spasticity in the legs;
2. Contractures in the lower extremities that prevent achieving a neutral hip and ankle position, or extended knee;
3. A prior lower extremity fragility fracture;
4. An injection of botulinum toxin to leg muscles in the past six months;
5. Peripheral nerve damage in the legs (i.e. leg muscles unresponsive to electrical stimulation);
6. A pressure sore (>grade 2) on the pelvis or trunk where the safety harness is applied; o
7. 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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)	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

Collaborators and Investigators

• Sponsor: University Health Network, Toronto
• Investigators: Principal Investigator: Kristin E Musselman, PhD, University of Toronto

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): April 30, 2017
• Primary Completion (Actual): November 14, 2018
• Study Completion (Actual): June 5, 2019

Study Registration Dates

• First Submitted: February 4, 2020
• First Submitted That Met QC Criteria: February 7, 2020
• First Posted (Actual): February 10, 2020

Study Record Updates

• Last Update Posted (Actual): May 23, 2023
• Last Update Submitted That Met QC Criteria: May 19, 2023
• Last Verified: February 1, 2020

More Information

Terms related to this study

• Keywords: Balance; Functional Electrical Stimulation
• Additional Relevant MeSH Terms: Central Nervous System Diseases; Nervous System Diseases; Trauma, Nervous System; Wounds and Injuries; Spinal Cord Diseases; Spinal Cord Injuries
• Other Study ID Numbers: 17-5151

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No