Restoring Upright Mobility After Spinal Cord Injury

NCT ID: NCT04262414

Last Updated: 2023-05-23

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 5 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-04-30
• Study Completion Date: 2019-06-05

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Interventions

Functional Electrical Stimulation

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.

Intervention Type: DEVICE

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University Health Network, Toronto

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Kristin E Musselman, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Toronto

Locations

Lyndhurst Centre, Toronto Rehabilitation Institute-UHN

Toronto, Ontario, Canada

Countries

Canada

References

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.

Reference Type: DERIVED

PMID: 33794948 (View on PubMed)

Other Identifiers

17-5151

Identifier Type: -

Identifier Source: org_study_id