Restoring Upright Mobility After Spinal Cord Injury

Not Applicable

Completed

• Conditions: Spinal Cord Diseases; Spinal Cord Injuries

• Registration Number: NCT04262414
• Lead Sponsor: University Health Network, Toronto

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2017-04-30
• Primary Completion: 2018-11-14
• Study Completion: 2019-06-05
• Status Verified: 2020-02
• Study First Submitted: 2020-02-04
• Study First Submitted QC: 2020-02-07
• Study First Posted: 2020-02-10
• Last Update Submitted: 2023-05-19
• Last Update Posted: 2023-05-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 5

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).

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Mini-Balance Evaluation Systems Test	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
Activities-specific Balance Confidence Scale	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)
Berg Balance Scale	Change from Baseline Berg Balance Scale at 8 weeks	Assesses static and dynamic standing balance; score 0-56; higher score means a better outcome

Secondary Outcome Measures

Name	Time	Method
Static standing balance	Through study completion, average of 8 weeks	Postural sway during quiet standing
Dynamic standing balance	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)
Semi-structured interview	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

Trial Locations

Locations (1)

Lyndhurst Centre, Toronto Rehabilitation Institute-UHN; 🇨🇦 Toronto, Ontario, Canada