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Restoring Upright Mobility After Spinal Cord Injury

Primary Purpose

Spinal Cord Injuries, Spinal Cord Diseases

Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Functional Electrical Stimulation
Sponsored by
University Health Network, Toronto
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Spinal Cord Injuries focused on measuring Balance, Functional Electrical Stimulation

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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Participants will be withdrawn from the study if FES irritates their skin.

Sites / Locations

  • Lyndhurst Centre, Toronto Rehabilitation Institute-UHN

Outcomes

Primary Outcome Measures

Berg Balance Scale
Assesses static and dynamic standing balance; score 0-56; higher score means a better outcome
Mini-Balance Evaluation Systems Test
Assesses four balance control systems, including anticipatory balance, reactive postural control, sensory orientation and dynamic gait
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)

Secondary Outcome Measures

Static standing balance
Postural sway during quiet standing
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)
Semi-structured interview
The guide will include open-ended questions concerning the participant's experience with, and impressions of, A-FES therapy

Full Information

First Posted
February 4, 2020
Last Updated
May 19, 2023
Sponsor
University Health Network, Toronto
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1. Study Identification

Unique Protocol Identification Number
NCT04262414
Brief Title
Restoring Upright Mobility After Spinal Cord Injury
Official Title
Restoring Upright Mobility After Spinal Cord Injury Using Functional Electrical Stimulation
Study Type
Interventional

2. Study Status

Record Verification Date
February 2020
Overall Recruitment Status
Completed
Study Start Date
April 30, 2017 (Actual)
Primary Completion Date
November 14, 2018 (Actual)
Study Completion Date
June 5, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Health Network, Toronto

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Spinal Cord Injuries, Spinal Cord Diseases
Keywords
Balance, Functional Electrical Stimulation

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
5 (Actual)

8. Arms, Groups, and Interventions

Intervention Type
Device
Intervention Name(s)
Functional Electrical Stimulation
Intervention Description
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.
Primary Outcome Measure Information:
Title
Berg Balance Scale
Description
Assesses static and dynamic standing balance; score 0-56; higher score means a better outcome
Time Frame
Change from Baseline Berg Balance Scale at 8 weeks
Title
Mini-Balance Evaluation Systems Test
Description
Assesses four balance control systems, including anticipatory balance, reactive postural control, sensory orientation and dynamic gait
Time Frame
Change from Baseline Mini-Balance Evaluation Systems Test at 8 weeks
Title
Activities-specific Balance Confidence Scale
Description
A measure of balance self-efficacy; mean score of 0-100; higher score means a better outcome (i.e. high balance confidence)
Time Frame
Change from Baseline Activities-specific Balance Confidence Scale at 8 weeks
Secondary Outcome Measure Information:
Title
Static standing balance
Description
Postural sway during quiet standing
Time Frame
Through study completion, average of 8 weeks
Title
Dynamic standing balance
Description
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)
Time Frame
Through study completion, average of 8 weeks
Title
Semi-structured interview
Description
The guide will include open-ended questions concerning the participant's experience with, and impressions of, A-FES therapy
Time Frame
up to 8 weeks post-intervention

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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). Exclusion Criteria: 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kristin E Musselman, PhD
Organizational Affiliation
University of Toronto
Official's Role
Principal Investigator
Facility Information:
Facility Name
Lyndhurst Centre, Toronto Rehabilitation Institute-UHN
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M4G 3V9
Country
Canada

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
33794948
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.
Results Reference
derived

Learn more about this trial

Restoring Upright Mobility After Spinal Cord Injury

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