Restoring Upright Mobility After Spinal Cord Injury

Spinal Cord Injuries Clinical Trial

Official title:

Restoring Upright Mobility After Spinal Cord Injury Using Functional Electrical Stimulation

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04262414
• Other study ID #: 17-5151
• Status: Completed
• Phase: N/A
• Start date: April 30, 2017
• Est. completion date: June 5, 2019

Study information

• Verified date: February 2020
• Source: University Health Network, Toronto
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 5
• Est. completion date: June 5, 2019
• Est. primary completion date: November 14, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Spinal Cord Diseases
• Spinal Cord Injuries
• Wounds and Injuries

Intervention

Device:
• 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.

Locations

Country	Name	City	State
Canada	Lyndhurst Centre, Toronto Rehabilitation Institute-UHN	Toronto	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
University Health Network, Toronto

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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	Static standing balance	Postural sway during quiet standing	Through study completion, average of 8 weeks
Secondary	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
Secondary	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