Clinical trial NCT04262414: Restoring Upright Mobility After Spinal Cord Injury
Official title: Restoring Upright Mobility After Spinal Cord Injury Using Functional Electrical Stimulation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Spinal Cord Injuries
Spinal Cord Diseases
Keywords: Balance
Functional Electrical Stimulation
Lead sponsor: University Health Network, Toronto
Sponsor class: OTHER
First posted: 2020-02-10
Enrollment: 5
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: Berg Balance Scale
timeFrame: Change from Baseline Berg Balance Scale at 8 weeks
measure: Mini-Balance Evaluation Systems Test
timeFrame: Change from Baseline Mini-Balance Evaluation Systems Test at 8 weeks
measure: Activities-specific Balance Confidence Scale
timeFrame: Change from Baseline Activities-specific Balance Confidence Scale at 8 weeks
Secondary outcomes:
measure: Static standing balance
timeFrame: Through study completion, average of 8 weeks
measure: Dynamic standing balance
timeFrame: Through study completion, average of 8 weeks
measure: Semi-structured interview
timeFrame: up to 8 weeks post-intervention
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: Lyndhurst Centre, Toronto Rehabilitation Institute-UHN
state: Ontario
Study officials:
affiliation: University of Toronto
name: Kristin E Musselman, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.