Restoring Upright Mobility After Spinal Cord Injury

NCT04262414 | Completed

• 1 other identifier: 17-5151
• Study Type: interventional
• Target: 5
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Spinal Cord Injuries; Spinal Cord Diseases

Keywords

Balance; Functional Electrical Stimulation

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (3)

• Static standing balance

  Through study completion, average of 8 weeks

• Dynamic standing balance

  Through study completion, average of 8 weeks

• Semi-structured interview

  up to 8 weeks post-intervention

Interventions

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• University Health Network, Toronto: lead

Study Sites (1)

Lyndhurst Centre, Toronto Rehabilitation Institute-UHN

Toronto, Ontario, M4G 3V9, Canada

Location

Related Publications (1)

• 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.

  PMID: 33794948 DERIVED

MeSH Terms

Conditions

Spinal Cord Injuries; Spinal Cord Diseases

Condition Hierarchy (Ancestors)

Central Nervous System Diseases; Nervous System Diseases; Trauma, Nervous System; Wounds and Injuries

Study Officials

• Kristin E Musselman, PhD

  University of Toronto

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 4, 2020
• First Posted: February 10, 2020
• Study Start: April 30, 2017
• Primary Completion: November 14, 2018
• Study Completion: June 5, 2019
• Last Updated: May 23, 2023

Record last verified: 2020-02

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)